Readiness For Decannulation Research Articles

Weaning strategies for children on home invasive mechanical ventilation.

Children who require home mechanical ventilation (HMV) with an artificial airway or invasive mechanical ventilation (HMV) have a possibility of successful weaning due to the potential of compensatory lung growth. Internationally accepted guidelines on how to wean from HMV in children is not available, we summarize the weaning strategies from the literature reviews combined with our 27-year experience in the Pediatric Home Respiratory Care program at the tertiary care center in Thailand. The readiness to wean is considered in patients with hemodynamic stability, having effective cough measured by maximal inspiratory pressure, requiring a fraction of inspired oxygen (FiO2) < 40%, positive end expiratory pressure <5 cmH2O, and acceptable arterial blood gases. The strategies of weaning is start weaning during the daytime while the child is awake and close monitoring is feasible. Disconnect time is gradually increased through naps and sleeping hours. Weaning from the conventional mechanical ventilator to Bilevel PAP or CPAP are optional. Factors affected the successful weaning are mainly the underlying diseases, complications, growth and development, caregivers, and resources. Weaning should be stopped during acute illness or increased work of breathing. The readiness for decannulation could be determined by using the speaking devices, tracheostomy capping, and measurement of end-expiratory pressure. Polysomnography and airway evaluation by bronchoscopy are recommended before decannulation.Weaning when the child is ready is crucial because living with HMV can be challenging and stressful. Failure to remove a tracheostomy when indicated can result in delayed speech, social problems as well as risk for infection.

Transtracheal Pressure for Evaluation of Decannulation Readiness.

Pediatric tracheostomy decannulation protocols vary among institutions and may include toleration of Passy Muir Valve (PMV), microlaryngoscopy and bronchoscopy (MLB) findings, and polysomnography evaluation. Transtracheal pressure (TTP) is an objective measurement utilized to evaluate PMV toleration. We aimed to investigate the role of TTP in decannulation candidates and compare TTP measurements with polysomnography and MLB findings. A retrospective cohort study of children who underwent TTP measurement during PMV trial between December 2012 and November 2022. A total of 79 patients underwent TTP measurement and MLB evaluation; of these, 16 (20.3%) patients had a capped polysomnography. Twenty-eight (35.4%) patients had TTPs ≤10 cm H2O, and 51 (64.6%) patients had TTPs >10 cm H2O. The most common indication for tracheostomy was upper airway obstruction (n = 41, 51.9%), followed by a need for mechanical ventilation (n = 24, 30.4%). Twenty-five (31.6%) patients were decannulated. Patients with TTPs ≤10 cm H2O had a mean Apnea-Hypopnea Index of 0.17 ± 0.26/h compared with 6.93 ± 7.67/h in those with TTPs >10 cm H2O, p = 0.0365. Patients with TTPs >10 cm H2O were found to have a significantly higher occurrence of airway obstruction (96.1% vs. 46.4%, p < 0.0001) and multilevel airway obstruction (70.6% vs. 21.4%, p < 0.0001) on MLB. Neither TTP measured at time of PMV assessment nor capped polysomnography was associated with successful decannulation. TTP measurements at time of PMV evaluation are associated with polysomnography and MLB findings. One-time PMV measurements were not indicative of decannulation success. 4 Laryngoscope, 134:3377-3383, 2024.

Weaning assessment of veno-arteriovenous (V-AV) extracorporeal membrane oxygenation (ECMO)

Currently, there is a lack of methods for simultaneous assessment of readiness for decannulation of the veno-venous (V-V) and veno-arterial (V-A) components during veno-arteriovenous (V-AV) extracorporal membrane oxygenation (ECMO) support. We describe a novel approach using a simultaneous off-sweep and controlled backflow test to assess readiness for decannulation from V-AV ECMO. This method needs testing in future clinical trials.

0526 Utility of polysomnography in tracheostomy decannulation process in children

Abstract Introduction Different approaches have been used to assess decannulation readiness including clinical observation with gradual tracheostomy downsizing, capping, and microlaryngoscopy and bronchoscopy. Polysomnograms with tracheostomy capping are being used at some centers prior to decannulation. We have previously shown that polysomnography is an important additional tool to predict successful decannulation. However, this study was based on a relatively small number of children. Thus the aim of this study is to review the polysomnographic features that predict decannulation outcomes in a large cohort of children with various conditions. Methods A retrospective chart review of polysomnography and medical records was performed for children 0-18 years of age preparing for tracheostomy decannulation from Feb. 2005 to June 2019 at Cincinnati Children’s Hospital Medical Center. Subjects with less than four hours of sleep time were excluded from the study. Results A total of 128 subjects were included in the study with 74 in the successful decannulation group (SD), 48 in the no decannulation group (ND) and 6 in the unsuccessful decannulation group. Underlying diagnosis included history of prematurity 41 (32%), genetic disorders 39 (30.5%), neurological disorders 17 (13.3%), airway abnormalities 108 (84.4%), and cardiac disease 24 (18.8%). Average age at the time of tracheostomy was 1.8±3.4 years and at decannulation was 5.7±3.6 years in the SD group. Favorable microlaryngoscopy/bronchoscopy (MLB) was significantly higher in SD group 73.8% vs. ND group 26.2% (p&amp;lt;0.001). Comparing polysomnographic respiratory sleep parameters showed significant differences between ND and SD groups for apnea hypopnea index (AHI)&amp;gt;10/h (88% [ND] vs. 12% [SD]; p&amp;lt;0.001) and obstructive apnea hypopnea index (OAHI)&amp;gt; 5/h (75.6% [ND] vs. 24.4% [SD]; p&amp;lt;0.001). Alveolar hypoventilation (CO2&amp;gt;50 for &amp;gt;25% of TST) was also significantly higher in the ND group (70.6%) vs. SD group (29.4%) (p&amp;lt;0.009). Conclusion In our large cohort of children undergoing decannulation, there were several differences in polysomnographic characteristics including AHI, obstructive AHI and CO2 parameters between those who were and were not successfully decannulated. In addition to unfavorable findings on airway evaluation, children who did not undergo decannulation were more likely to have moderate to severe degree of sleep disordered breathing and alveolar hypoventilation. Support (If Any) This study was supported by Cincinnati Children’s Hospital Research Fund.

Comprehensive Monitoring in Patients With Dual Lumen Right Atrium to Pulmonary Artery Right Ventricular Assist Device.

Right ventricular assist devices (RVADs) can be used in patients with acute right heart failure. A novel device that has recently been deployed is the right atrium to pulmonary artery (RA-PA) dual lumen single cannula (DLSC). One of the limitations is that it occupies a large proportion of the right ventricular outflow tract and PA; therefore, standard continuous hemodynamic monitoring with a pulmonary artery catheter is commonly not used. Serial echocardiography is pivotal for device deployment, monitoring device position, assessing RV readiness for decannulation, and surveilling for short-term complications. We performed a retrospective case series of 24 patients with RA-PA DLSC RVAD assessing echocardiographic RV progression and vasoactive infusion requirements. The overall survival was 66.6%. The average vasoactive infusion score at the time of cannulation was 24.9 ± 43.9, at decannulation in survivors 4.6 ± 4.9 vs . 25.4 ± 21.5 in nonsurvivors, and 2.7 ± 4.9 at 48 hours post decannulation. On echocardiography, the average visual estimate of RV systolic function encoded (0 = none and 5 = severe) in survivors was 3.9 ± 1.2, 2.8 ± 1.6, 2.5 ± 1.7, and 2.8 ± 1.9, respectively, and in nonsurvivors 3.8 ± 1.6 and 3.4 ± 1.8, respectively. This demonstrated an RV systolic function improvement over time in survivors as opposed to nonsurvivors. This was also demonstrated in RV size visual estimate, respectively. Quantitatively, at the predefined four timepoints, the RV:LV, tricuspid annular plane systolic excursion, and fractional area change all improve over time and there is statistically significant difference in survivors versus nonsurvivors. In this study, we describe a cohort of patients treated with RA-PA DLSC RVAD. We illustrate the critical nature of echocardiographic measures to rate the progression of RV function, improvement in vasoactive infusion requirements, and ventilator parameters with the RA-PA DLSC.

17 Decannulation Following Tracheostomy in Children: A Systematic Review

Abstract Primary Subject area Respirology Background Despite the large morbidity and potential mortality associated with tracheostomy tube decannulation failure, there are currently no consensus guidelines on pediatric tracheostomy decannulation. This has led to wide practice variation that is largely based on expert option. This is the largest review of pediatric decannulation protocols. Objectives To systematically review the literature on existing pediatric decannulation protocols, including the role of polysomnography, and their clinical outcomes. Design/Methods Five online databases were searched for relevant studies from database inception to May 29, 2020. Study inclusion was limited to publications that evaluated tracheostomy decannulation in children 18 years of age and younger. Independent reviewers extracted data, including patient demographics and primary indication for tracheostomy. Methods used to assess readiness for decannulation were noted, including the use of bronchoscopy, tracheostomy tube modifications, and gas exchange measurements. After decannulation, details regarding mode of ventilation, location and length of observation period, and clinical outcomes were also collected. Quality assessment of included studies was performed using the Newcastle-Ottawa Scale (NOS) tool. Descriptive statistical analyses were performed. Results Twenty-three studies with 1328 children were included (Figure 1). Tracheostomy indications included upper airway obstruction at a well-defined anatomic site (37%), upper airway obstruction not at a well-defined site (13%), and need for long-term ventilation (50%). Bronchoscopy was routinely used in 96% of protocols. Tracheostomy tube modifications in the protocols included capping (83%), downsizing (57%), and fenestrations (9%). Measurements of gas exchange in the protocols included polysomnography (72%), oximetry (61%), blood gases (17%), and capnography with end-tidal CO2 (17%). After tracheostomy decannulation, children in 92% of protocols were transitioned to room air, and 38% of protocols used non-invasive ventilation. Most children (76%) were observed in hospital for 48 hours or less. Of all decannulation attempts, 79% were successful. Overall risk of bias in included studies was low. Conclusion The absence of clear evidence-based guidelines in pediatric tracheostomy decannulation has led to large variability in clinical practice. Most protocols include bronchoscopy, tube modifications, gas exchange measurements, and brief hospital admission. Polysomnography plays an integral role in assessing the majority of children for tracheostomy removal. Evidence-based guidelines to standardize pediatric tracheostomy care remain an urgent priority.

Preparation for decannulation of children with the consequences of cervical vertebrospinal cord injuries in surgical hospitals

BACKGROUND: Approximately 40 million people worldwide suffer from vertebrospinal cord injuries every year. According to different authors, children account for 1% to 5% of those injured. The relevance of developing a protocol for preparing children with vertebrospinal cord injuries for decannulation is due to the frequency of respiratory disorders and the peculiarities of the mechanism of their occurrence in patients with cervical spinal cord injuries, the lack of clear recommendations on preparing the patient for decannulation, and early comprehensive rehabilitation measures that contribute to restoring or compensating respiratory, muscular function, and the need for a unique approach to performing rehabilitation measures that consider the age of the child.&#x0D; AIM: This study aims to develop a preparation protocol and an algorithm for decannulation of children with cervical vertebrospinal cord injuries and assess the efficiency of early rehabilitative measures in the preparation process.&#x0D; MATERIALS AND METHODS: This study included 74 children with vertebrospinal cord injuries admitted to the Emergency Childrens Surgery and Traumatology Research Institute from 2014 to 2019. The patients were divided into two groups depending on the time of admission. Group 1 consisted of children admitted to the institute in the acute and early periods of vertebrospinal cord injuries. Group 2 included children in the intermediate and recovery periods. All patients were prepared for spontaneous breathing according to the protocol.&#x0D; RESULTS AND DISCUSSION: Group 1 patients with C2C4 vertebrospinal cord injury levels were decannulated on days 110140 after the injury. One child was diagnosed with an overgrowth of granulations over the tracheostomy tube, which required medical correction followed by successful decannulation. Group 1 patients with C5C8 vertebrospinal cord injury levels were decannulated on days 1541 after the injury. All Group 1 patients underwent early rehabilitation measures, which began immediately after stabilizing vital functions.&#x0D; On days 97110 after the injury, 12 patients of Group 2 with С5С8 vertebrospinal cord injury levels were decannulated. In contrast to Group 1 patients with the same injuries, Group 2 patients did not undergo early rehabilitation measures in primary inpatient settings. Therefore, they required much more time to adapt to spontaneous breathing.&#x0D; CONCLUSIONS: Compliance with the proposed protocol allows determining the patients readiness for decannulation, reduces the risk of potential complications that may arise due to the untimely removal of the tracheostomy tube, increases the effectiveness of rehabilitation measures in this patient category, and reduces the length of the hospital stay. The preparation algorithm for decannulation may serve as a practical guide for specialists involved in treating and rehabilitating children with vertebrospinal cord injuries.

Decannulation following tracheostomy in children: A systematic review of decannulation protocols.

To provide a systematic review of the existing pediatric decannulation protocols, including the role of polysomnography, and their clinical outcomes. Five online databases were searched from database inception to May 29, 2020. Study inclusion was limited to publications that evaluated tracheostomy decannulation in children 18 years of age and younger. Data extracted included patient demographics and primary indication for tracheostomy. Methods used to assess readiness for decannulation were noted including the use of bronchoscopy, tracheostomy tube modifications, and gas exchange measurements. After decannulation, details regarding mode of ventilation, location, and length of observation period, and clinical outcomes were also collected. Descriptive statistical analyses were performed. A total of 24 studies including 1395 children were reviewed. Tracheostomy indications included upper airway obstruction at a well-defined anatomic site (35%), upper airway obstruction not at a well-defined site (12%) and need for long-term ventilation and pulmonary care (53%). Bronchoscopy was routinely used in 23 of 24 (96%) protocols. Tracheostomy tube modifications in the protocols included capping (n = 20, 83%), downsizing (n = 14, 58%), and fenestrations (n = 2, 8%). Measurements of gas exchange included polysomnography (n = 13/18, 72%), oximetry (n = 10/18, 56%), blood gases (n = 3,17%), and capnography (n = 3, 17%). After decannulation, children in 92% of protocols were transitioned to room air. Observation period of 48 h or less was used in 76% of children. There exists large variability in pediatric decannulation protocols. Polysomnography plays an integral role in assessing most children for tracheostomy removal. Evidence-based guidelines to standardize pediatric tracheostomy care remain an urgent priority.

Standardized Endoscopic Swallowing Evaluation for Tracheostomy Decannulation in Critically Ill Neurologic Patients \u2013 a prospective evaluation

BackgroundRemoval of a tracheostomy tube in critically ill neurologic patients is a critical issue during intensive care treatment, particularly due to severe dysphagia and insufficient airway protection. The “Standardized Endoscopic Evaluation for Tracheostomy Decannulation in Critically Ill Neurologic Patients” (SESETD) is an objective measure of readiness for decannulation. This protocol includes the stepwise evaluation of secretion management, spontaneous swallowing, and laryngeal sensitivity during fiberoptic endoscopic evaluation of swallowing (FEES). Here, we first evaluated safety and secondly effectiveness of the protocol and sought to identify predictors of decannulation success and decannulation failure.MethodsA prospective observational study was conducted in the neurological intensive care unit at Münster University Hospital, Germany between January 2013 and December 2017. Three hundred and seventy-seven tracheostomized patients with an acute neurologic disease completely weaned from mechanical ventilation were included, all of whom were examined by FEES within 72 h from end of mechanical ventilation. Using regression analysis, predictors of successful decannulation, as well as decannulation failure were investigated.ResultsTwo hundred and twenty-seven patients (60.2%) could be decannulated during their stay according to the protocol, 59 of whom within 24 h from the initial FEES after completed weaning. 3.5% of patients had to be recannulated due to severe dysphagia or related complications. Prolonged mechanical ventilation showed to be a significant predictor of decannulation failure. Lower age was identified to be a significant predictor of early decannulation after end of weaning. Transforming the binary SESETD into a 4-point scale helped predicting decannulation success in patients not immediately ready for decannulation after the end of respiratory weaning (optimal cutoff ≥1; sensitivity: 64%, specifity: 66%).ConclusionsThe SESETD showed to be a safe and efficient tool to evaluate readiness for decannulation in our patient collective of critically ill neurologic patients.

International Pediatric Otolaryngology Group (IPOG) management recommendations: Pediatric tracheostomy decannulation

ObjectivesTo provide recommendations to otolaryngologists, pulmonologists, and allied clinicians for tracheostomy decannulation in pediatric patients. MethodsAn iterative questionnaire was used to establish expert recommendations by the members of the International Pediatric Otolaryngology Group. ResultsTwenty-six members completed the survey. Recommendations address patient criteria for decannulation readiness, airway evaluation prior to decannulation, decannulation protocol, and follow-up after both successful and failed decannulation. ConclusionTracheostomy decannulation recommendations are aimed at improving patient-centered care, quality and safety in children with tracheostomies.

High-Flow Oxygen with Capping or Suctioning for Tracheostomy Decannulation

BackgroundWhen patients with a tracheostomy tube reach a stage in their care at which decannulation appears to be possible, it is common practice to cap the tracheostomy tube for 24 hours to see whether they can breathe on their own. Whether this approach to establishing patient readiness for decannulation leads to better outcomes than one based on the frequency of airway suctioning is unclear.MethodsIn five intensive care units (ICUs), we enrolled conscious, critically ill adults who had a tracheostomy tube; patients were eligible after weaning from mechanical ventilation. In this unblinded trial, patients were randomly assigned either to undergo a 24-hour capping trial plus intermittent high-flow oxygen therapy (control group) or to receive continuous high-flow oxygen therapy with frequency of suctioning being the indicator of readiness for decannulation (intervention group). The primary outcome was the time to decannulation, compared by means of the log-rank test. Secondary outcomes included decannulation failure, weaning failure, respiratory infections, sepsis, multiorgan failure, durations of stay in the ICU and hospital, and deaths in the ICU and hospital.ResultsThe trial included 330 patients; the mean (±SD) age of the patients was 58.3±15.1 years, and 68.2% of the patients were men. A total of 161 patients were assigned to the control group and 169 to the intervention group. The time to decannulation was shorter in the intervention group than in the control group (median, 6 days [interquartile range, 5 to 7] vs. 13 days [interquartile range, 11 to 14]; absolute difference, 7 days [95% confidence interval, 5 to 9]). The incidence of pneumonia and tracheobronchitis was lower, and the duration of stay in the hospital shorter, in the intervention group than in the control group. Other secondary outcomes were similar in the two groups.ConclusionsBasing the decision to decannulate on suctioning frequency plus continuous high-flow oxygen therapy rather than on 24-hour capping trials plus intermittent high-flow oxygen therapy reduced the time to decannulation, with no evidence of a between-group difference in the incidence of decannulation failure. (REDECAP ClinicalTrials.gov number, NCT02512744.)

Inter-rater and test-retest reliability of the \u201cstandardized endoscopic swallowing evaluation for tracheostomy decannulation in critically ill neurologic patients\u201d

BackgroundRemoval of a tracheostomy tube in critically ill neurologic patients is a difficult issue, particularly due to the high incidence of oropharyngeal dysphagia. For an objective evaluation of decannulation readiness the “Standardized Endoscopic Swallowing Evaluation for Tracheostomy Decannulation in Critically Ill Neurologic Patients” (SESETD) – a stepwise evaluation of ‘secretion management’, ‘spontaneous swallows’ and ‘laryngeal sensibility/cough’ – has been introduced. With the recent study detailed data on inter-rater and test-retest reliability are presented.MethodsTo obtain inter-rater reliability levels both in a group of raters with at least 5 years of experience (‘experts’) and in a group of raters with no or only minor experience using the SESETD (‘non-experts’), for each single item of the protocol and the sum score α-, respectively κ-levels were determined. The ‘experts’ assessed the same videos after a four-week interval to determine test-retest reliability. Ten videos from tracheostomized neurological patients completely weaned from mechanical ventilation were assessed independently by six ‘experts’. 27 ‘non-experts’ applied the SESETD on 5 videos from the same patient population after introduction to the protocol in a one-hour workshop.ResultsFor the items ‘secretion management’ and ‘spontaneous swallows’ α-levels were identified at > 0.800 both in the group of ‘experts’ and ‘non-experts’. With regard to the item ‘laryngeal sensibility/cough’ in both groups, the α-level was ≥0.667. With κ-levels of 1.0 for ‘secretion management’, 0.93 for ‘spontaneous swallows’ and 0.76 for ‘laryngeal sensibility/cough’ test-retest reliability showed at least substantial agreement for each item. Intraclass correlation coefficient for the sum score was excellent in both groups (α ≥ 0.90).ConclusionsThe SESETD demonstrates good to excellent agreement for each single item included as well as the sum score in experienced and unexperienced raters supporting its usefulness for implementation in daily clinical routine and as an outcome measure for clinical trials.

Tracheostomy decannulation methods and procedures for assessing readiness for decannulation in adults: a systematic scoping review.

Despite the undisputable benefits of tracheostomy, it has been reported to have links with impaired communication, reduced quality of life and a risk of health complications such as bleeding, tracheal stenosis and in some cases resulting in mortality. There is a paucity of literature on tracheostomy decannulation methods and procedures, leaving the decision to expert opinion and institutional guidelines. This study aimed to map evidence on methods and procedures of tracheostomy decannulation in adults and assessment of readiness for decannulation, to reveal knowledge gaps and inform further research. We conducted a systematic search of peer reviewed and grey literature on PubMed/MEDLINE, Google Scholar, Union Catalogue of Theses and Dissertations via SABINET Online, World Cat Dissertations and Theses via OCLC, WHO library and governmental websites from 1985 to present. Following title screening, abstract and full article screening was performed by two independent reviewers guided by the eligibility criteria. Data from included studies were extracted, collated, summarized and synthesized into the following themes: assessment, removal, monitoring and definition of failure of decannulation. Quality of the included studies was assessed using the Mixed Methods Appraisal Tool version 2011. Twenty-five out of 51 screened articles were eligible for data extraction. There was wide variation in the assessment methods employed across and within similar patient groups. The common themes that emerged in the assessment for readiness for decannulation are informed consent, clinical stability, airway patency, physiological decannulation, swallowing assessment, level of consciousness, effectiveness of cough and clearance of secretions. In conclusion, the current body of evidence is inadequate and requires further research, particularly validation of different parameters used. A protocol approach to decannulation may be inappropriate but rather an algorithmic approach using validated parameters.

The role of polysomnography in decannulation of children with brain and spinal cord injuries.

The objective of this retrospective review was to determine the utility of polysomnography (PSG) in influencing the decision to decannulate pediatric patients with brain and spinal cord injuries in an inpatient rehabilitation hospital setting. Between 2010 and 2016, data were collected on pediatric patients with brain and/or spinal cord injuries who had PSG performed with the goal of decannulation. Patients underwent a decannulation protocol involving toleration of continuous tracheostomy capping and bedside tracheoscopy by otolaryngology. Decision to decannulate was determined with input from multiple disciplines. Associations were examined between decannulation success and findings on PSG as well as demographic factors, injury characteristics, otolaryngology findings, and timeline from initial injury to selected events. A total of 46 patients underwent PSG, after which 38 (83%) were deemed appropriate and eight (17%) were deemed inappropriate for decannulation. Individuals who were deemed ready for decannulation had significantly lower obstructive apnea hypopnea indexes (AHI) (1.7 vs 5.4 events/h, P = 0.03), respiratory disturbance indexes (RDI) (2.4 vs 7.6 events/h, P = 0.006), and peak end tidal carbon dioxide (CO2 ) levels (50.0 vs 58.7 torr, P = 0.009) on PSG compared to those who were not decannulated. There were no complications following decannulation prior to discharge. PSG provided important additional information as part of a multidisciplinary team assessment of clinical readiness for decannulation in pediatric patients with brain and spinal cord injuries who underwent a decannulation protocol. Obstructive AHI, RDI, and peak end tidal CO2 level were associated with successful decannulation prior to discharge from inpatient rehabilitation.

PHAryngeal electrical STimulation for early decannulation in TRACheotomised stroke patients with neurogenic dysphagia (PHAST-TRAC): a prospective randomised single-blinded trial

Background Dysphagia after stroke is common, especially in severely affected, tracheotomised patients. In a pilot trial, pharyngeal electrical stimulation (PES) improved swallowing function in this group of patients. The PHAryngeal electrical STimulation for early decannulation in TRACheotomised stroke patients with neurogenic dysphagia trial (PHAST-TRAC) was designed to replicate and extend this single-centre experience. Methods Patients with recent stroke who required tracheotomy were randomised to receive three days of PES or sham. All patients had the stimulation catheter inserted; sham treatment was applied by connecting the base station to a simulator box instead of the catheter. Randomisation was done via a computerised interactive system with randomisation (stratified by site) in blocks of 4 patients per site. Patients and investigators applying PES were not masked. The primary-endpoint was assessed blinded to treatment assignment by a separate investigator at each site. The primary outcome was readiness for decannulation 24-72 hours post-treatment, assessed using fiberoptic endoscopic evaluation of swallowing and based on a standardised protocol including absence of massive saliva, presence of spontaneous swallows and laryngeal sensation. We planned a sequential statistical analysis of superiority for the primary endpoint. Interim analyses were to be performed after primary outcome data were available for 50 patients (futility), 70 patients, and every additional 10 patients thereafter up to 140. Analysis was by intention-to-treat. The trial was registered as ISRCTN18137204. Findings From 29th May 2015 to 5th July 2017, 69 patients (PES 35, sham 34) from 9 sites (7 acute care hospitals, 2 rehabilitation facilities) in Germany, Austria and Italy were included: PES group mean age 61.7 (SD 13.0) years, 8 (23%) patients with haemorrhagic stroke, median time onset to randomisation 28.0 [IQR 20, 49] days; sham group age 66.8 (10.3) years, 12 (35%) patients with haemorrhagic stroke, onset to randomisation 28.0 [18, 40] days). The Independent Data & Safety Monitoring Board recommended to stop the trial early for efficacy after 70 patients had been recruited and primary endpoint data of 69 patients were available. This decision was approved by the steering committee. PES was associated with more patients being ready for decannulation as compared to sham: 17 (49%) vs. 3 (9%), odds ratio (OR) 7.00 (2.41-19.88), p=0.00082). No patient required recannulation within 48 hours or during their documented follow-up period up to 30 days or hospital discharge. Adverse events (AEs) were reported in 24 patients (69%) of the PES group and 24 patients (71%) of the sham group. The number of patients with at least one serious adverse event (SAE) did not differ between the groups: 10 (29%) vs. 8 (23%), OR 1.3 (0.44-3.83), p=0.7851). 7 patients (20%) from the PES group and 3 patients (9%) from the sham group died during the study period. None of the patient deaths or SAEs reported were judged to be PES-treatment- or investigational device-related. Interpretation PES increased the proportion of patients with stroke and subsequent tracheotomy who were ready for decannulation in this study population, many of whom received PES within a month of their stroke. Future trials should confirm whether PES is beneficial in tracheostomised patients who receive stimulation similarly early after stroke and explore its effects in other cohorts.

Pharyngeal electrical stimulation for early decannulation in tracheotomised patients with neurogenic dysphagia after stroke (PHAST-TRAC): a prospective, single-blinded, randomised trial

Dysphagia after stroke is common, especially in severely affected patients who have had a tracheotomy. In a pilot trial, pharyngeal electrical stimulation (PES) improved swallowing function in this group of patients. We aimed to replicate and extend this single-centre experience. We did a prospective, single-blind, randomised controlled trial across nine sites (seven acute care hospitals, two rehabilitation facilities) in Germany, Austria, and Italy. Patients with recent stroke who required tracheotomy were randomly assigned to receive 3 days of either PES or sham treatment (1:1). All patients had the stimulation catheter inserted; sham treatment was applied by connecting the PES base station to a simulator box instead of the catheter. Randomisation was done via a computerised interactive system (stratified by site) in blocks of four patients per site. Patients and investigators applying PES were not masked. The primary endpoint was assessed by a separate investigator at each site who was masked to treatment assignment. The primary outcome was readiness for decannulation 24-72 h after treatment, assessed using fibreoptic endoscopic evaluation of swallowing and based on a standardised protocol, including absence of massive pooling of saliva, presence of one or more spontaneous swallows, and presence of at least minimum laryngeal sensation. We planned a sequential statistical analysis of superiority for the primary endpoint. Interim analyses were to be done after primary outcome data were available for 50 patients (futility), 70 patients, and every additional ten patients thereafter, up to 140 patients. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN18137204. From May 29, 2015, to July 5, 2017, of 81 patients assessed, 69 patients from nine sites were randomly assigned to receive PES (n=35) or sham (n=34) treatment. Median onset to randomisation time was 28 days (IQR 19-41; PES 28 [20-49]; sham 28 [18-40]). The Independent Data and Safety Monitoring Board recommended that the trial was stopped early for efficacy after 70 patients had been recruited and primary endpoint data for 69 patients were available. This decision was approved by the steering committee. More patients were ready for decannulation in the PES group (17 [49%] of 35 patients) than in the sham group (three [9%] of 34 patients; odds ratio [OR] 7·00 [95% CI 2·41-19·88]; p=0·0008). Adverse events were reported in 24 (69%) patients in the PES group and 24 (71%) patients in the sham group. The number of patients with at least one serious adverse event did not differ between the groups (ten [29%] patients in the PES group vs eight [23%] patients in the sham group; OR 1·30 [0·44-3·83]; p=0·7851). Seven (20%) patients in the PES group and three (9%) patients in the sham group died during the study period (OR 2·58 [0·61-10·97]; p=0·3059). None of the deaths or serious adverse events were judged to be related to PES. In patients with stroke and subsequent tracheotomy, PES increased the proportion of patients who were ready for decannulation in this study population, many of whom received PES within a month of their stroke. Future trials should confirm whether PES is beneficial in tracheotomised patients who receive stimulation similarly early after stroke and explore its effects in other cohorts. Phagenesis Ltd.

Impact of functional status and medical comorbidities on tracheostomy decannulation in pediatric patients.

To determine if medical or functional factors influence the ability of a pediatric patient with a tracheostomy to tolerate decannulation. Retrospective evaluation of patients at a tertiary Children's Hospital undergoing evaluation with capped tracheostomy polysomnogram (cPSG) for possible tracheostomy decannulation. Charts were reviewed for demographic information, functional status, cPSG characteristics, and success or failure of decannulation. Statistical analysis was performed to determine which patient factors were predictive of successful decannulation. A total of 139 sleep studies were analyzed in 104 unique children followed for at least 1 year after a cPSG was performed to determine readiness for decannulation. At 1 year after most recent PSG, 79.8% of children were decannulated. There was no significant association between any single comorbid condition and the ability to decannulate. There was no association between individual or total functional status score and successful decannulation. Patients with at least 3 comorbid conditions investigated and a total functional score less than 7 were less likely to be decannulated successfully than other patients (71% vs. 93%, p= 0.04). Functional status and comorbid conditions do not independently predict successful decannulation. Regular multi-disciplinary team reevaluation is indicated in patients with lower functional status, as removal of tracheostomy tube may be successfully accomplished.

The role of polysomnography in tracheostomy decannulation of the paediatric patient

IntroductionTracheostomy decannulation in the paediatric patient is usually considered when there is resolution or significant improvement in the original indication for the tracheostomy. The child's cardiorespiratory function needs to be optimized and assessment of the readiness for decannulation is generally by endoscopic evaluation to confirm airway patency and vocal cord mobility. Functional airway assessment procedures include downsizing the tracheostomy, adding fenestration, speaking valves and capping the tracheostomy tube.Few objective measures have been demonstrated to accurately predict the likelihood of successful decannulation. This study aims to evaluate the usefulness of polysomnography (PSG) with a capped tracheostomy tube, as an adjunct to airway endoscopy and traditional decannulation procedures, to predict decannulation outcome. MethodsA retrospective review was conducted for patients who underwent “capped” PSG prior to a trial of tracheostomy decannulation at the Sydney Children's Hospitals Network. The charts were reviewed for clinical data and PSG results. Results30 children with a total of 40 PSG reports were included in this study. There was a statistically significant difference in mean oxygen saturation, minimum oxygen saturation, total apnoea/hypopnoea index, desaturations >3%, and desaturations >3% index between those that had successful decannulation compared to failed decannulation. The measures with the greatest significance, and therefore, the best predictors of decannulation outcome were total apnoea/hypopnoea index (3.35events/h vs. 18.5events/h, p=0.004) and desaturation events (20.33 events vs. 192 events, p=0.001). ConclusionsPSG with a capped tracheostomy tube is a useful, objective tool to complement endoscopy and functional airway assessment in the consideration of decannulation in the paediatric population.

Pediatric tracheotomy decannulation

Pediatric tracheotomy is a common procedure. Given the risk of morbidity and mortality associated with long-term placement, it is imperative that decannulation is considered once the indication for tracheotomy placement is corrected or resolved. In this article, we discuss the critical steps necessary for the assessment of readiness for decannulation, and we review the recent literature that supports several methods of evaluation that may be incorporated into a protocol for decannulation. Recent literature related to the topics of pediatric tracheotomy and decannulation is limited to case series and retrospective reviews, though relatively large patient populations are encompassed within individual studies. The data presented support the use of routine predecannulation endoscopic exam, as well as progressive daytime and overnight inpatient capping trials to ensure adequate airway patency, capped polysomnography for patients with underlying obstructive sleep apnea and/or dynamic airway disease, and 24-h inpatient observation after decannulation to determine tolerance and detect early failures requiring tracheotomy replacement. Although the assessment of readiness for decannulation may be challenging, several evaluative steps are recommended to ensure safe and effective decannulation in pediatric patients. Apparent variation in decannulation outcomes by underlying cause may herald the development of indication-specific decannulation protocols in the future.

The value of cough peak flow measurements in the assessment of extubation or decannulation readiness

Insufficient cough strength has a major role in extubation and decannulation outcomes.Cough capacity can be easily evaluated by measuring flows during coughing. Values vary depending on whether cough flows are measured through the mouth or through a tracheostomy or endotracheal tube. It is important to standardize these measurements and start using them routinely in the extubation and decannulation processes. Values of cough peak flow >160L/min measured at the mouth or a value of cough PEF >60L/min measured at the endotracheal tube suggest successful decannulation or extubation.