Airway Clearance Devices in Pediatrics: A Future Reality?

Airway clearance management in people with bronchiectasis: data from the European Bronchiectasis Registry (EMBARC).

BackgroundForeign body airway obstructions (FBAOs, choking) are a significant cause of preventable mortality. Abdominal thrusts, back blows, and chest compressions are traditional interventions. However, suction-based airway clearance devices (ACDs) have recently been marketed as an alternative. Of note, there is limited published evidence regarding their efficacy and safety. Our research has two aims: (1) to investigate what situational and patient factors are frequently identified, and which are associated with relief of the FBAO and survival in individuals with FBAOs treated with an ACD; and (2) to describe the experience of individuals who have used ACDs in response to a FBAO and identify facilitators and barriers to the use of ACDs compared to traditional interventions.Methods and analysisA prospective database will be developed using an online reporting system to capture ACD uses, independent of manufacturers, from July 1st, 2021 to December 31st, 2023. Descriptive statistics will be used to summarize cases, outcomes, and adverse events. Clinically important subgroups will be stratified for analysis, including the severity of obstruction, patient demographics, and training of ACD users. Semi-structured interviews will also be conducted with a subset of ACD users to describe in detail their experience using the device. Themes from these interviews will be assessed using the theoretical domains framework.DiscussionThis study will improve the evidence surrounding ACDs and compare it to current data for traditional techniques, with the aim of optimizing FBAO treatment. Data on ACDs are urgently needed as these devices are already being used by parents, caregivers, lay rescuers, and healthcare professionals to respond to choking emergencies. This evaluation will provide important information about their effectiveness and any safety concerns which can inform the public, resuscitation guidelines, and future research studies.

Knowledge and skills of pediatric residents in managing pediatric foreign body airway obstruction using novel airway clearance devices in Spain: A randomized simulation trial

A 2-year prospective evaluation of airway clearance devices in foreign body airway obstructions

Respiratory treatment for cystic fibrosis (CF) patients includes use of respiratory devices. Contamination of airway clearance devices has not been adequately explored. We aimed to determine whether airway clearance devices are contaminated after use and whether cleaning guidelines for nebulizers are as effective for airway clearance devices. Patients brought their airway clearance devices to the clinic. Swabs from the devices were taken before and after cleaning and were cultured for bacterial counts. Total colony-forming units (CFU) was determined, and predominant colonies were identified using Matrix-Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry technology. Thirty devices were collected from 23 patients. Most of the devices (28/30) were contaminated when brought to the clinic. Complete bacterial eradication was achieved in 15 (50%) samples and partial eradication in 9 (30%). The cleaning was totally ineffective in four samples. Median CFU decreased significantly from 1250 (IQR 25–75% 175–10.000) to 0 (IQR 25–75% 0–700) before and after cleaning (p < 0.0001). The predominant organisms were identified in five samples only, and there was no concordance with sputum culture results. Airway clearance devices are contaminated after use, and appropriate cleaning can reduce contamination. The effect on disease progression in CF patients is unclear. There is a need for infection prevention and control guidelines for the growing number of respiratory devices.

Productive cough with sputum is a prominent sign generally associated with respiratory diseases, including chronic obstructive pulmonary disease (COPD). Airway clearance devices are an option for COPD management, but physicians' preferences for and clinical practice with them are not known. This study aims to explore preferences for and clinical practice with airway clearance devices among physicians in Saudi Arabia. An observational, cross-sectional survey. A self-administered questionnaire was conducted between October 2022 and September 2023, which included a review of respiratory medication prescriptions by physicians for patients with COPD. The analysis was performed using the Statistical Package for the Social Sciences. The participants were 445 physicians. The majority were female, accounting for 64.3% of the sample. Flutter and Acapella were the most commonly preferred airway clearance devices (45.8% and 20.7%, respectively). Among the participants, 12.6% reported unfamiliarity with any of the mentioned devices. Of the participants, 43.6% "usually" suggested the devices for patients with daily, difficult-to-clear, thick sputum, while 27% "sometimes" recommended them to COPD patients who had experienced four exacerbations or more. In routine clinical practice, physicians prescribe pharmacological therapies as the main treatment. The prescribing data showed that in the last year, there was no record of prescribed airway clearance devices for COPD by physicians. Family and pulmonary physicians prefer Flutter and Acapella devices, but a significant number of physicians are unaware of such devices. Prescribing data showed no record of prescribed airway clearance devices for COPD management. Further initiatives are needed to increase awareness in clinical practice.

Background: Choking is a prevalent source of injury and mortality worldwide. Traditional choking interventions, including abdominal thrusts and back blows, have remained the standard of care for decades despite limited published data. Suction-based airway clearance devices (ACDs) are becoming increasingly popular and there is an urgent need to evaluate their role in choking intervention. The aim of this study was to describe the effectiveness (i.e., resolution of choking symptoms) and safety (i.e., adverse events) of identified airway clearance devices interventions to date. Methods: This retrospective descriptive analysis included any individual who self-identified to manufacturers as having used an ACD as a choking intervention prior to 1 July 2021. Records were included if they contained three clinical variables (patient’s age, type of foreign body, and resolution of choking symptoms). Researchers performed data extraction using a standardized form which included patient, situational, and outcome variables. Results: The analysis included 124 non-invasive (LifeVac©) and 61 minimally invasive (Dechoker©) ACD interventions. Median patient age was 40 (LifeVac©, 2–80) and 73 (Dechoker©, 5–84) with extremes of age being most common [<5 years: LifeVac© 37.1%, Dechoker© 23.0%; 80+ years: 27.4%, 37.7%]. Food was the most frequent foreign body (LifeVac© 84.7%, Dechoker© 91.8%). Abdominal thrusts (LifeVac© 37.9%, Dechoker© 31.1%) and back blows (LifeVac© 39.5%, Dechoker© 41.0%) were often co-interventions. Resolution of choking symptoms occurred following use of the ACD in 123 (LifeVac©) and 60 (Dechoker©) cases. Three adverse events (1.6%) were reported: disconnection of bellows/mask during intervention (LifeVac©), a lip laceration (Dechoker©), and an avulsed tooth (Dechoker©). Conclusion: Initial available data has shown ACDs to be promising in the treatment of choking. However, limitations in data collection methods and quality exist. The second phase of this evaluation will be an industry independent, prospective assessment in order to improve data quality, and inform future choking intervention algorithms.

Introduction: Airway clearance devices (ACDs) may improve symptoms and lung function in Chronic Obstructive Pulmonary Disease (COPD) with mucus hyperproduction or bronchiectasis but innovation needs to be evaluated. Aim: Aim of study was to assess feasibility and effects of a new ACD in hospitalized COPD patients suffering from chest congestion despite optimal medical treatment. Methods: 32 patients with AECOPD and symptoms of excessive mucus congestion were treated during 6 days with medical treatment, pulmonary rehabilitation and airway clearance with either manual chest physiotherapy (control; n=13) or new ACD (Simeox, Physio-Assist; n=19) that facilitates bronchial drainage by generating pulses of negative air pressure during relaxed exhalations. Usability, spirometry, CAT score, safety and tolerance were evaluated. Results: Baseline: age 67.3 6.7, 69% male, GOLD 2/3/4: 19%/31%/50%, GOLD B/C/D: 3%/19%/78%, 31% bronchiectasis (BE), 66% had ICS/LABA/LAMA, CAT score 29.0±3.3. Patient training required 15 min during the first session. No adverse event nor pain was reported. FEV1 increased by 19±10% and 14±5% in device and control group (NS), respectively. However, improvement of CAT score was higher in device group (-34±9% vs control: -24±4%; p Conclusion: These results confirmed the feasibility of this new technology to manage mucus problems in COPD and suggested that it may contribute to improve respiratory symptoms and quality of life in the most severe patients

Background: Effective airway clearance is a critical component of COPD management. Airway clearance devices (ACDs) can assist this, but their effectiveness relies on consistent use in clinical practice. Objectives: To identify awareness and clinical practice related to device use for people with COPD among respiratory therapists and physiotherapists in Saudi Arabia. Design: A cross-sectional survey. Setting: Primary and secondary care in Saudi Arabia Material and Methods: An online survey was conducted among respiratory care and physiotherapy practitioners working in various healthcare settings across Saudi Arabia. The survey assessed familiarity with, attitudes towards, and utilisation of different types of ACDs in different clinical scenarios. Results: A total of 423 healthcare practitioners were invited to complete the survey, which included 43% female participants, a median age range of 20-30 years, 89.4% Saudi citizens, 82.5% with a bachelor’s degree, 84.2% who are respiratory therapists, and 58.9% employed in governmental hospitals. Almost all participants were aware of at least one ACD, with Flutter devices (58%) being the most recognised, followed by Acapella (30%). 77.5% of participants reported always or usually using devices in patients with daily difficulty in clearing thick sputum, but there was less consistency where the sputum burden was not as severe. The Acapella device was preferred by 56%, with 18% preferring the Flutter. 85% of participants reported basing device use on clinical practice guidelines, with the GOLD guidelines being the most cited. Conclusion: Awareness of sputum clearance devices is high among this group of healthcare professionals in Saudi Arabia, but variation in practice highlights the need for further research. Keywords: Chronic Obstructive Pulmonary Disease, Airway Clearance Devices, Adjunct for Sputum Clearance, Respiratory Therapy, Physiotherapy, Saudi Arabia

Background: Foreign body airway obstruction (FBAO; choking) can quickly lead to respiratory arrest&amp;death. As FBAOs occur in prehospital settings, survival depends heavily on bystander intervention. Suction-based airway clearance devices (ACDs) are marketed as safer alternatives to traditional maneuvers such as abdominal thrusts. While a previous mannequin study found the LifeVac ACD more effective than AT among healthcare professionals, laypersons are the intended users. Research Question: Among laypersons, which FBAO intervention—abdominal thrusts (AT), LifeVac ACD (LV), or Dechoker ACD (DC)—is most efficacious at relieving an FBAO within one minute? Methods: We conducted a simulation-based, open-label, randomized crossover trial in Alberta, Canada. Adult laypersons received standardized in-person instruction on AT, LV, and DC. Each participant responded to three separate simulated FBAO events (one per intervention), with random assignment to one of six intervention order groups. The outcomes were FBAO relief at one minute (primary) and at four minutes (secondary). Attempts were videotaped and outcomes were assessed by two independent hypothesis-blinded adjudicators. A mixed-effects logistic regression model estimated odds ratios (OR) for FBAO relief, adjusted for sequence, carryover, and period effects. Skill retention was evaluated 90–120 days later without retraining, using the same simulation protocol. Target sample size was 132. Results: Over 7 months, 136 participants were enrolled; 132 were eligible and randomized. Most were female (66%), with a median age of 39 (IQR:26-56). Sixty-eight participants (52%) had current first aid certification, while 40 (30%) had never received first aid training. Adjudicators had perfect outcome agreement (Cohen’s k=1.0). FBAO relief at one minute occurred in 86% (LV), 62% (DC), and 49% (AT) of cases; at four minutes: 97% (LV), 81% (DC), 52% (AT). Compared to AT, LV (OR=12.4; 95%CI: 5.6–27.2) and DC (OR=2.1; 95%CI: 1.2–3.8) had higher odds of one-minute relief. Results were similar at four minutes. In the retention phase, 39 participants returned. At one minute, LV remained superior (OR=97.7; 95%CI: 6.3–1549), while DC did not (OR=1.4; 95%CI: 0.5–4.0); similar findings were observed at four minutes. Conclusion: After brief training, both ACDs were more efficacious than abdominal thrusts in relieving a simulated FBAO among laypersons. However, at 3–4 months post-training, only LifeVac ACD retained superior efficacy.

BackgroundChest physiotherapy plays a crucial role in managing cystic fibrosis, especially during pulmonary exacerbations. This study evaluated the effects of adding a new airway clearance device to chest physiotherapy in subjects with cystic fibrosis hospitalised due to pulmonary exacerbations.MethodsThis prospective open-label study was carried out at the Pediatric Cystic Fibrosis Centre in Poland between October 2017 and August 2018. Cystic fibrosis patients aged 10 to 18 years who were admitted to the hospital and required intravenous antibiotic therapy due to pulmonary exacerbations were consecutively allocated (1:1) to either chest physiotherapy alone or chest physiotherapy with a new airway clearance device (Simeox; PhysioAssist). Patients performed spirometry and multiple-breath nitrogen washout for lung clearance index assessment upon admission and prior to discharge.ResultsForty-eight cystic fibrosis patients were included (24 in each group). Spirometry parameters in both groups improved significantly after intravenous antibiotic therapy. A significant improvement in the maximum expiratory flow at 25% of forced vital capacity was observed only in the group with a new airway clearance device (p < 0.01 vs. baseline). Trends towards a lower lung clearance index ratio were similar in both groups. No adverse events were observed in either group.ConclusionsSpirometry parameters increased significantly in cystic fibrosis patients treated for pulmonary exacerbations with intravenous antibiotic therapy and intensive chest physiotherapy. The new airway clearance device was safe and well tolerated when added to chest physiotherapy and may be another option for the treatment of pulmonary exacerbation in cystic fibrosis.

Introduction: Airway clearance devices (ACDs) assist in mobilizing retained secretions in lung diseases by increasing the velocity of expiratory flow. Aim: Aim of this study was to characterize oscillatory flow and negative expiratory pressure pulses generated by a new ACD in healthy subjects. Methods: 10 healthy adults activated a device (Simeox, PhysioAssist) generating intermittent pulses of intrapulmonary negative air pressure during relaxed exhalations. The procedure was repeated twice with 4 settings (25% or 100% power at 6 or 12 Hz frequency). Oscillatory flow and pressure pulses were measured at the mouth with a flow sensor (TSI, Certifier FA plus) to assess Maximal expiratory flow (MEF), maximal mid-expiratory flow (MMEF), Mean expiratory flow (EFmean), maximal expiratory flow amplitude (MEFamp), peak of negative expiratory pressure (NEPpeak) and maximal expiratory pressure amplitude (MEPamp). Results: 60% male, 34±12y, FEV1/FVC 90±14%. Data are presented in table 1. MEF (60 to 120 l/min) and MEFamp (70 to140 l/min) rates supported generation of high airflow velocity during exhalation over power range. Oscillatory flow was maintained at mid-exhalation. Low variability of data showed high reproducibility of flow and negative pressure pulses generated with Simeox during procedure. Range of pressure was safe (-10 to -60 mbar). Conclusions: These data suggest that Simeox may be an efficient and secure technology for airway clearance therapy.

Foreign Body Airway Obstruction (FBAO) is a medical emergency that can result in death, particularly if swift, appropriate action is not taken. It can be a frightening experience for all involved. DeChoker, an Airway Clearance Device (ACD), might provide an additional alternative in the management of choking; however, limited evidence around its safety and effectiveness makes adoption controversial.Objectives: An independent evaluation to explore the experiences of health and care professionals who used DeChoker in real-life adult choking emergencies, focusing on the product's safety, efficacy and ease of application.Design: Retrospective mixed methods case study, with multiple embedded units of analysis.Setting: UK adult care homes.Participants: Twenty seven incidents of adult choking emergencies self-reported by care home staff where DeChoker was used. This data was augmented by an in-depth exploration of four individual choking incidences.Results: The choking victim's ages range: 45 to 101 years (mean 79.8 years). The device was reported to have successfully removed the obstruction in 26 of 27 cases, with very few complications or adverse events reported. In 21 of 27 incidents (78%) the victim was not required to visit Accident and Emergency. Qualitative data indicated nursing home staff found the DeChoker easy to use and valued its presence as an adjunct to current guideline procedures.Conclusion: There is a dearth of evidence surrounding the management of choking and little innovation in this area for five decades. This retrospective evaluation contributes to discussion regarding the role ACDs might play in the management of choking, particularly in cases where current choking management guidance are ineffective, insufficient, inappropriate or impractical (e.g., frail or movement restricted people). The interview data presents a view from care home staff that the DeChoker, as an ACD, contributed to saving the life of choking victims.

Airway clearance devices in cystic fibrosis

Introduction: Clinical guidelines recommend airway clearance techniques (ACTs) in adults with bronchiectasis. There is a paucity of evidence about their clinical implementation, particularly in different healthcare systems. Multicentre registries can facilitate studying patterns and differences across countries. Methods: Outpatients with bronchiectasis were prospectively recruited to the multicentre European Bronchiectasis Registry EMBARC. Patient-reported ACTs were registered in 31 countries. Demographic, baseline health status, exacerbations, radiology, and treatments were recorded. Results: Data were collected between 2015 and 2018. 13,512 patients participated, mean (SD) age 64.2 (14.6) years old, 8,121 females (60.1%). Only 48.3% of the participants reported performing airway clearance regularly. The most commonly used techniques were active cycle of breathing techniques (ACBT) (26.8%) and postural drainage (6.0%). 21.2% of patients used one or more airway clearance devices. Flutter (8.9%), fixed positive expiratory pressure (PEP) (6.5%) and Acapella (4.4%) were the most commonly used ones. The vast majority of patients perform regular ACTs in Denmark (91.7%) and Finland (88.7%), compared to less than 10% of participants in Bulgaria, North Macedonia, Moldova, Romania, and Sweden. The primary reason for not doing airway clearance was that it was not required in the opinion of the clinicians (67.9%). Conclusions: Most patients with bronchiectasis do not routinely perform ACTs. Clinicians’ opinion is often that bronchiectasis patients do not require ACTs. Acknowledgments: EMBARC has received support from the EU/EFPIA Innovative Medicines Initiative Joint Undertaking iABC grant agreement no 115721.