CAP Trial Research Articles

A Simplified Protocol for Tracheostomy Decannulation in Patients Weaned off Prolonged Mechanical Ventilation.

Introduction The criteria for the removal of the tracheostomy tube (decannulation) vary from center to center. Some perform an endoscopic evaluation under anesthesia or computed tomography, which adds to the cost and discomfort. We use a simple two-part protocol to determine the eligibility and carry out the decannulation: part I consists of airway and swallowing assessment through an office-based flexible laryngotracheoscopy, and part II involves a tracheostomy capping trial. Objective The primary objective was to determine the safety and efficacy of the simplified decannulation protocol followed at our center among the patients who were weaned off the mechanical ventilator and exhibited good swallowing function clinically. Methods Of the patients considered for decannulation between November 1st, 2018, and October 31st, 2020, those who had undergone tracheostomy for prolonged mechanical ventilation were included. The efficacy to predict successful decannulation was calculated by the decannulation rate among patients who had been deemed eligible for decannulation in part I of the protocol, and the safety profile was defined by the protocol's ability to correctly predict the chances of risk-free decannulation among those submitted to part II of the protocol. Results Among the 48 patients included (mean age: 46.5 years; male-to-female ratio: 3:1), the efficacy of our protocol in predicting the successful decannulation was of 87.5%, and it was was safe or reliable in 95.45%. Also, in our cohort, the decannulation success and the duration of tracheotomy dependence were significantly affected by the neurological status of the patients. Conclusion The decannulation protocol consisting of office-based flexible laryngotracheoscopy and capping trial of the tracheostomy tube can safely and effectively aid the decannulation process.

Effect of Speaking Valves on Tracheostomy Decannulation.

Introduction Despite several pediatric tracheostomy decannulation protocols there remains tremendous variability in practice. The effect of tracheostomy capping on decannulation has been studied but the role of speaking valves (SVs) is unknown. Objective Given the positive benefits SVs have on rehabilitation, we hypothesized that SVs would decrease time to tracheostomy decannulation. The purpose of the present study was to evaluate this in a subset of patients with chronic lung disease of prematurity (CLD). Methods A retrospective chart review was performed at a tertiary care children's hospital. A total of 105 patients with tracheostomies and CLD were identified. Data collected included demographics, gestational age, congenital cardiac disease, airway surgeries, granulation tissue excisions, SV and capping trials, tracheitis episodes, and clinic visits. Statistics were performed with logistic and linear regression. Results A total of 75 patients were included. The mean gestational age was 27 weeks (standard deviation [SD] = 3.6) and the average birthweight was 1.1 kg (SD = 0.6). The average age at tracheostomy was 122 days (SD = 63). A total of 70.7% of the patients underwent decannulation and the mean time to decannulation (TTD) was 37 months (SD = 19). A total of 77.3% of the patients had SVs. Those with an SV had a longer TTD compared to those without (52 versus 35 months; p = 0.008). Decannulation was increased by 2 months for every increase in the number of hospital presentations for tracheitis ( p = 0.011). Conclusion The present study is the first, to our knowledge, to assess the effect of SVs on tracheostomy decannulation in patients with CLD showing a longer TTD when SVs are used.

Pediatric tracheostomy decannulation: what's the evidence?

Pediatric decannulation failure can be associated with large morbidity and mortality, yet there are no published evidence-based guidelines for pediatric tracheostomy decannulation. Tracheostomy is frequently performed in medically complex children in whom it can be difficult to predict when and how to safely decannulate. Published studies regarding pediatric decannulation are limited to reviews and case series from single institutions, with varying populations, indications for tracheostomy, and institutional resources. This article will provide a review of published decannulation protocols over the past 10 years. Endoscopic airway evaluation is required to assess the patency of the airway and address any airway obstruction prior to decannulation. There is considerable variability in tracheostomy tube modification between published protocols, though the majority support a capping trial and downsizing of the tracheostomy tube to facilitate capping. Most protocols include overnight capping in a monitored setting prior to decannulation with observation ranging from 24 to 48 h after decannulation. There is debate regarding which patients should have capped polysomnography (PSG) prior to decannulation, as this exam is resource-intensive and may not be widely available. Persistent tracheocutaneous fistulae are common following decannulation. Excision of the fistula tract with healing by secondary intention has a lower reported operative time, overall complication rate, and postoperative length of stay. Pediatric decannulation should occur in a stepwise process. The ideal decannulation protocol should be safe and expedient, without utilizing excessive healthcare resources. There may be variability in protocols based on patient population or institutional resources, but an explicitly described protocol within each institution is critical to consistent care and quality improvement over time. Further research is needed to identify selection criteria for who would most benefit from PSG prior to decannulation to guide allocation of this limited resource.

Safety evaluation of a stepwise tracheostomy decannulation program in pediatric patients.

In the event of failed tracheostomy decannulation, patients might have a tragic course of events. We retrospectively evaluated our stepwise tracheostomy decannulation program and examined its safety. A 12-year retrospective study of pediatric patients was conducted. The decannulation program was performed on patients who had airway patency by laryngobronchoscopy and whose cannula could be capped during the day. A stepwise decannulation program was performed: continuous 48-h capping trial during hospitalization (Phase 1), removal of the tracheostomy tube for 48h during hospitalization (Phase 2), and outpatient observation (Phase 3). If a persistent tracheocutaneous fistula existed, the fistula was closed by surgery (Phase 4). The 77 patients in the study underwent 86 trials. The age at the first time of the decannulation program was 6.5 ± 3.6years. Sixteen trials failed (18.6%): 8 trials in Phase 1, 2 trials in Phase 2, 4 trials in Phase 3, and 2 trials in Phase 4. Most decannulation failures were due to desaturation in Phase 1/2 and dyspnea in Phase 3/4. The time to reintubation after decannulation was 15-383days in Phase 3/4. Patients could fail at every phase of the program, suggesting that a stepwise decannulation program contributes to safety.

Tracheal airway pressure in tracheostomy tube capping trials: an experimental study

BackgroundTracheostomy tube capping is a commonly used test to determine if the tracheostomy tube can be removed. The success of the capping trial depends on the patient’s ability to maintain sufficient spontaneous breathing with an occluded tracheostomy tube. The impact of an occluded tracheotomy tube on airway resistance is currently unknown. The aim of this study was to investigate tracheal pressure during capping or stoma button insertion and potential determinants concerning cuff.MethodsEight cuffed and uncuffed tracheostomy tubes and three stoma buttons of various manufacturers and sizes were inserted into the trachea model. Cuffs were completely deflated or contained atmospheric pressure. The trachea was ventilated bidirectional with a respirator in volume-controlled mode and volume flows 15–60 L/min. Tracheal pressure drop during inspiration as a parameter of pressure required to move gas through the airway was measured.ResultsTracheal pressure drops occurred linearly or irregularly during capping trials to a maximum of 4.2 kPa at flow rates of 60 L/min for atmospheric pressure cuffs. In tracheostomy tubes with completely deflated cuffs, pressure drop in the trachea reaches a maximum of 3.4 kPa at a flow rate of 60 L/min. For tracheostomy tubes with cuff smaller inner or outer diameters do not regularly result in lower tracheal pressure drop. The pressure drop varies between different tracheostomy tubes depending on the manufacturer. In cuffed tracheostomy tubes, we observed three phenomena: sail-like positioning, folding over, and tightening of the cuff during flow. The maximum tracheal pressure drop during stoma button insertion reaches 0.014 kPa.ConclusionsThe cuff is a central element for the pressure drop in the airway and thus airway resistance during spontaneous translaryngeal breathing with a capped TT. Complete deflation reduces the pressure drop in the trachea. Due to deformation of the cuff, measured pressures are irregular as the volume flow is increased. Incomplete deflated cuffs and material characteristics of tracheostomy tubes and cuffs in addition to anatomical and clinical variables may cause unsuccessful capping trials due to increased airway resistance. All stoma buttons showed that pressure drop and thus airway resistance due to stoma buttons has no clinical relevance.

AGI grade-guided chaiqin chengqi decoction treatment for predicted moderately severe and severe acute pancreatitis (CAP trial): study protocol of a randomised, double-blind, placebo-controlled, parallel-group, pragmatic clinical trial

BackgroundAcute pancreatitis (AP) is a common digestive disease with increased incidence globally but without internationally licenced pharmacological therapy. Moderately severe and severe acute pancreatitis (MSAP/SAP) contributes predominately for its morbidities and mortality and has been managed in West China Hospital for decades using the traditional Chinese medicinal formula chaiqin chengqi decoction (CQCQD). The current study tests whether the early administration of CQCQD will result in improved clinical outcomes in predicted MSAP/SAP patients.MethodsThis is a single-centre, randomised, controlled, double-blind pragmatic clinical trial. AP patients aged 18–75 admitted within 72 h of onset will be assessed at admission for enrolment. We excluded the predicted mild acute pancreatitis (Harmless Acute Pancreatitis Score > 2 at admission) and severe organ failure (Sequential Organ Failure Assessment [SOFA] score of respiratory, cardiovascular, or renal systems > 3) at admission. Eligible patients will be randomly allocated on a 1:1 basis to CQCQD or placebo control administration based on conventional therapy. The administration of CQCQD and placebo is guided by the Acute Gastrointestinal Injury grade-based algorithm. The primary outcome measure will be the duration of respiratory failure (SOFA score of respiratory system ≥ 2) within 28 days after onset. Secondary outcome measures include occurrence of new-onset any organ failure (SOFA score of respiratory, cardiovascular, or renal system ≥ 2) and new-onset persistent organ failure (organ failure lasts > 48 h), dynamic surrogate biochemical markers and clinical severity scores, gut-centred treatment modalities, local complications status, intensive care need and duration, surgical interventions, mortality, and length of hospital stay. Follow-up will be scheduled on 6, 12, and 26 weeks after enrolment to assess AP recurrence, local complications, the requirement for surgical interventions, all-cause mortality, and patient-reported outcomes.DiscussionThe results of this study will provide high-quality evidence to appraise the efficacy of CQCQD for the early management of AP patients.Trial registrationChictr.org.cn Registry (ChiCTR2000034325). Registered on 2 July, 2020.

Prostate-specific antigen testing and opportunistic prostate cancer screening: a cohort study in England, 1998-2017.

BackgroundProstate cancer is a leading cause of cancer- related death. Interpreting the results from trials of screening with prostate-specific antigen (PSA) is complex in terms of defining optimal prostate cancer screening policy.AimTo assess the rates of, and factors associated with, the uptake of PSA testing and opportunistic screening (that is, a PSA test in the absence of any symptoms) in England between 1998 and 2017, and to estimate the likely rates of pre-randomisation screening and contamination (that is, unscheduled screening in the ‘control’ arm) of the UK-based Cluster Randomised Trial of PSA Testing for Prostate Cancer (CAP).Design and settingOpen cohort study of men in England aged 40–75 years at cohort entry (1998–2017), undertaken using the QResearch database.MethodEligible men were followed for up to 19 years. Rates of PSA testing and opportunistic PSA screening were calculated; Cox regression was used to estimate associations.ResultsThe cohort comprised 2 808 477 men, of whom 631 426 had a total of 1 720 855 PSA tests. The authors identified that 410 724 men had opportunistic PSA screening. Cumulative proportions of uptake of opportunistic screening in the cohort were 9.96% at 5 years’, 22.71% at 10 years’, and 44.13% at 19 years’ follow-up. The potential rate of contamination in the CAP control arm was estimated at 24.50%.ConclusionA substantial number of men in England opt in to opportunistic prostate cancer screening, despite uncertainty regarding its efficacy and harms. The rate of opportunistic prostate cancer screening in the population is likely to have contaminated the CAP trial, making it difficult to interpret the results.

When to start and stop caffeine and why respiratory status matters

Caffeine as tested in the CAP trial is safe and effective for preterm infants with birthweights less than 1250 g. Evidence for its use beyond the indications and timing used in this trial is of low quality and conflicting. Some studies suggest that earlier use of caffeine increases the risk of mortality while others suggest it has important benefits. It appears that infants with apnea of prematurity and those receiving assisted ventilation are the most likely to benefit from caffeine. Based on currently available evidence, routine early prescription of caffeine does not appear to be indicated. Infants continue to have potentially damaging episodes of hypoxia secondary to apnea beyond 34 weeks’ postmenstrual age. It is unclear whether prolonged use of caffeine improves outcomes in these infants. Randomized trials to resolve these uncertainties are required. They need to be large, at least the size of the CAP trial, and include neurodevelopmental outcomes.

History of caffeine use in neonatal medicine and the role of the CAP trial

History of caffeine use in neonatal medicine and the role of the CAP trial

Estimation of successful capping with complete aspiration of bladder via nephroureterostomy tube.

BACKGROUNDUreteral stent and nephroureterostomy tube (NUT) are treatments of ureteral obstruction. Ureteral stent provides better quality of life. Internalization of NUT is desired whenever possible.AIMTo assess outcomes of capping trial among cancer patients with complete aspiration of retained contrast from bladder via NUT.METHODSOur Institutional Review Board approved retrospective review of all NUT placement, NUT exchange and conversion of nephrostomy catheter into NUT performed during June 2013 to June 2015 (n = 578). Cases were excluded due to lack of imaging of bladder (n = 37), incomplete aspiration of bladder (n = 324), no attempt at capping NUT (n = 166), and patients with confounding factors interfering with results of capping trial including non-compliant bladder, bladder outlet obstruction and catheter malposition (n = 14). Study group consisted of 37 procedures in 34 patients (male 19, female 15, age 2-83 years, average 58, median 61) most with cancer (prostate 8, endometrial 5, bladder 4, colorectal 4, breast 2, gastric 2, neuroblastoma 2, cervical 1, ovarian 1, renal 1, sarcoma 1, urothelial 1 and testicular 1) and one with Crohn’s disease. Medical records were reviewed to assess outcomes of capping trial. Exact 95% confidence intervals (95%CI) were calculated.RESULTSAmong patients with complete aspiration of retained contrast, 30 (81%, 95%CI: 0.65-0.92) catheters were successfully capped (range 12-94 d, average 40, median 24.5) until planned conversion to internal stent (23), routine exchange (5), removal (1) or death unrelated to catheter (1). Seven capping trials (19%, 95%CI: 0.08-0.35) were unsuccessful (range 2-22 d, average 12, median 10) due to leakage (3), elevated creatinine (2), fever/hematuria (1) and nausea/vomiting (1).CONCLUSIONCapping trial success among patients with complete aspiration of retained contrast/ urine from bladder via NUT appears high.

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.)

Expiratory airflow obstruction due to tracheostomy tube: A spirometric study in 50 patients

Tracheostomy is commonly used in intensive care units and in head and neck departments. Airway obstruction due to occluded cuffless tracheostomy tubes themselves remains unknown, although capping trials are commonly used before decannulation. The aim of this study was to evaluate the extent to which airway obstruction can be caused by occluded cuffless tubes in patients who underwent head and neck surgery. Prospective Research Outcome. University teaching hospital. Fifty patients requiring transient tracheostomy after head and neck surgery. A flow-volume loop (FVL) through the mouth using a portable spirometer, with the occluded fenestrated cuffless tube, was measured before and immediately after decannulation, by obstructing the orifice of tracheostomy tube. The measurement of FVL recorded the forced vital capacity (FVC), forced expiratory volume in 1second (FEV1 ), peak expiratory flow (PEF), forced expiratory flow at 50% of FVC, peak inspiratory flow (PIF) and forced inspiratory flow at 50% of FVC. A statistically significant difference between all spirometric parameters was found. Mean PEF and PIF, respectively, increased from 2.8 to 4.5L/s (P<.0001) and 2.3 to 2.7L/s (P<.01) before and after decannulation, with a strong positive correlation (r=0.7; P<.05). A mean expiratory (34%) and inspiratory (9%) airflow reduction was observed due to cannula. Occluded cuffless tracheostomy tubes cause a dramatic airflow obstruction, mainly in the expiratory phase of FVL. This should be taken into account during capping trials.

PSAscreening and molecular markers

Prostate cancer (PCA) is the most common type of cancer in men. The significant increase in incidence is most likely caused by the overdiagnosis of prostate cancer by widespread prostate-specific antigen (PSA) screening. This article reviews the three largest randomized trials of PSA-based prostate cancer screening and the benefits and disadvantages of general PSA screening. It gives an overview about the strategies to avoid the harms from overdetection and overtreatment without missing clinically relevant tumors. This review article is based on aliterature search in the PubMed database on PSA-based screening, molecular serum markers and risk-adapted PSA screening. In contrast to the CAP and PLCO trial, the ERSPC study reports areduced relative and absolute mortality risk. Furthermore, the use of the PSA was associated with significantly lower risk of metastatic disease. In order to avoid unnecessary biopsy and overtreatment including treatment of insignificant prostate cancer, anumber of tests have been proposed to improve the specificity of the PSA screening including the PHI, the 4Kscore and the risk-adapted PSA screening. The assessment of a baseline PSA level in the fifth decade allows subsequent risk-adapted PSA screening intervals. This concept is currently evaluated by the largest prospective multicenter trial, the PROBASE-trial. Neither acomplete rejection of aPSA-based screening nor ageneral PSA testing is afinal solution to this dilemma. Arisk-adapted PSA screening according to abaseline PSA as well as serum markers may reduce unnecessary diagnostic and therapeutic interventions and its attendant morbidities without adecrease in sensitivity.

A genetic risk score to personalize prostate cancer screening, applied to population data.

181 Background: Genetic risk stratification may inform the decision of whether—and at what age—a man should undergo prostate cancer (PCa) screening. We previously validated a polygenic hazard score (PHS) for accurate prediction of age of onset of aggressive PCa and for improved screening PSA performance. The PHS is a weighted sum of 54 SNP genotypes. Here, we applied the PHS to population data to assess its potential impact on individualized screening. Methods: Age-specific PCa incidence data were obtained for men aged 40-70 years from the United Kingdom (Cancer Research UK, 2013-2015) and fit to an exponential curve as a continuous model of age-specific PCa incidence. Using hazard ratios estimated from ProtecT study data, annualized incidence rate curves were calculated for the following percentiles of genetic risk: 1, 5, 20, 50, 80, 95, and 99. The proportion of incidence classified as aggressive (Gleason score ≥7) was estimated as 59.7%, the reported result from the CAP trial. PHS was combined with incidence data to give a risk-equivalent age, when a man with given PHS percentile will have the same risk of aggressive PCa as that of a typical man at age 50 years. Results: The age-specific incidence rate of PCa for the UK population was modeled as: 0.004 e0.203(age-40) ( R2 = 0.957, p = 0.001). Table shows risk-equivalent age for each genetic risk percentile. For example, a man with a PHS in the 95th percentile reached PCa risk equivalent to a typical 50-year-old man at age 44 years; conversely, a man with a PHS in the first percentile does not reach this risk level until age 60 years. Initiation of screening discussions could be adjusted accordingly. Conclusions: PHS may inform PCa screening with individualized estimates of risk-equivalent age for aggressive PCa. Risk-equivalent age for aggressive prostate cancer, by PHS percentile. [Table: see text]

Abstract No. 542 Can cystic duct patency be a reliable indicator in the management of the a cholecystostomy tube?

Routinely, cholecystostomy tubes are placed in the septic patent who would otherwise be unfit for surgical management. Classical thought is that the patient should progress to cholecystectomy after recovery from the acute illness. However, with greater attention on outcomes, it seems that cholecystostomy tubes may be remaining in-situ for a longer duration. The goal of this study is to identify if patency of the cystic duct is a viable indicator for the removal of a cholecystostomy tube. We retrospectively reviewed all cholecystostomy tube placements between 2015 to 2016 at our institution. Cases where excluded tube placement was for an obstructing mass, palliative, prior cholecystostomy tube, or lost to follow-up. Data collected include indication for placement, age, duration until cystic duct opening and total tube time in situ, underwent a capping trial and outcome, surgery status, if the tube dislodged, and if died with tube in situ. Data was compared with a Cox Regression survival analysis and descriptive measures. 31 people (45.6% of eligible cholecystostomy tube placements) were identified to have a patent cystic duct during placement or with routine management. Half of the population had patency by 37 days after placement. There was no significance difference in time for the cystic duct to open between acute calculous versus acalculous cholecystitis as the indication for placement. As for outcomes, 45.3% proceeded with cholecystectomy, 12.9% passed with tube in-situ, and 42% where able to have the tube removed. Of those removed, 2 people (15.4%) had a recurrent cholecystitis at a mean of 246 days, who went on to tube replacement and subsequent tube removal at patency of cystic duct. Our analysis suggests that cystic duct patency may be a valid indicator for the management of a cholecystostomy tube without a large proportion of the population having to have re-intervention.

Are women with history of pre-eclampsia starting a new pregnancy in good nutritional status in South Africa and Zimbabwe?

BackgroundMaternal nutritional status before and during pregnancy is an important contributor to pregnancy outcomes and early child health. The aim of this study was to describe the preconceptional nutritional status and dietary intake during pregnancy in high-risk women from South Africa and Zimbabwe.MethodsThis is a prospective observational study, nested to the CAP trial. Anthropometric measurements before and during pregnancy and dietary intake using 24-h recall during pregnancy were assessed. The Intake Distribution Estimation software (PC-SIDE) was used to evaluate nutrient intake adequacy taking the Estimated Average Requirement (EAR) as a cut-off point.ResultsThree hundred twelve women who had pre-eclampsia in their last pregnancy and delivered in hospitals from South Africa and Zimbabwe were assessed. 73.7 and 60.2% women in South Africa and Zimbabwe, respectively started their pregnancy with BMI above normal (BMI ≥ 25) whereas the prevalence of underweight was virtually non-existent. The majority of women had inadequate intakes of micronutrients. Considering food and beverage intake only, none of the micronutrients measured achieved the estimated average requirement. Around 60% of pregnant women reported taking folic acid or iron supplements in South Africa, but almost none did so in Zimbabwe.ConclusionWe found a high prevalence of overweight and obesity and high micronutrient intake inadequacy in pregnant women who had the previous pregnancy complicated with pre-eclampsia. The obesity figures and micronutrient inadequacy are issues of concern that need to be addressed. Pregnant women have regular contacts with the health system; these opportunities could be used to improve diet and nutrition.Trial registrationPACTR201105000267371. Registered 06 December 2010.

Abstract No. 574 Ability to aspirate retained contrast from bladder via nephroureterostomy tube (NUT) is a predictor of successful capping trial

Abstract No. 574 Ability to aspirate retained contrast from bladder via nephroureterostomy tube (NUT) is a predictor of successful capping trial

Cross-sectional study evaluating data quality of the National Cancer Registration and Analysis Service (NCRAS) prostate cancer registry data using the Cluster randomised trial of PSA testing for Prostate cancer (CAP)

ObjectivesTo compare the completeness and agreement of prostate cancer data recorded by the National Cancer Registration and Analysis Service (NCRAS) with research-level data specifically abstracted from medical records from the...

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.

Long-Term Outcomes of a Benign Biliary Stricture Protocol

PurposeTo evaluate long-term outcomes of a structured protocol for percutaneous treatment of benign biliary stricture. Materials and MethodsSeventy-one patients (37 men, 34 women; mean age, 54 y; age range, 23–84 y) entered the protocol, which consisted of staged upsizing of internal/external biliary catheters, balloon dilation (nominally 8 mm), and prolonged stent treatment (6 mo) at maximal catheter size (nominally 18 F). It concluded with a capping trial and catheter removal if the stricture remained patent. Fifty-three patients completed the protocol and 18 did not (6 died, 6 underwent alternative treatment, 4 were lost to follow-up, and 2 underwent repeat transplantation). Stricture features, treatment parameters, complications, and outcomes were reviewed, and Kaplan–Meier analysis was conducted. ResultsStrictures were anastomotic in 45 patients (64%), intrahepatic in 14 (20%), extrahepatic in 7 (10%), and multiple (intra- and extrahepatic) in 5 (7%). A right-sided approach was used in 47 patients (66%) patients, a left-sided approach in 18 (25%), and a bilateral approach in 6 (9%). Forty-six patients who entered the protocol (65%) and 46 patients who completed the protocol (87%) showed stricture patency. Four of 7 patients in whom a capping trial failed underwent surgical revision, 2 required chronic biliary drainage, and 1 received a metal stent. Follow-up (range, 0–12 y; mean, 4.7 y) was obtained for 42 of 53 patients who completed the protocol (79%). Kaplan–Meier analysis showed stricture patency probabilities of 84% at 1 year after treatment, 78% at 2 years, 74% at 5 years, and 67% at 10 years. ConclusionsUse of a structured protocol for the percutaneous treatment of benign biliary strictures yields durable long-term results, suggesting that percutaneous treatment is an effective therapy.