Is High Resolution Endotracheal Tube Leak Data Indicative of the Development of Post-extubation Stridor in Children?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Post Extubation Stridor. Basic parameters: up to 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PES: Is High Resolution Endotracheal Tube Leak Data Indicative of the Development of Post-extubation Stridor in Children?
Overview
Post extubation stridor (PES) is a common and possibly serious complication of invasive ventilation via endotracheal tube (ETT) in pediatric intensive care (PICU) patients. The source of the PES is either temporary in the case of post-intubation laryngeal edema, or long-term in the case of subglottic stenosis.
Detailed description
Post extubation stridor (PES) is a common and possibly serious complication of invasive ventilation via endotracheal tube (ETT) in pediatric intensive care (PICU) patients. The source of the PES is either temporary in the case of post-intubation laryngeal edema, or long-term in the case of subglottic stenosis.
Patients with PES could be in acute respiratory distress and failure requiring: 1. Medical Intervention (i.e. nebulized adrenaline, steroids or need for re-intubation), 2. Diagnostic Procedures (direct laryngoscopy) or 3. Temporary or permanent surgical airway - all leading to longer admissions and possible long term complications.
Several studies have tried to determine whether the development of PES is predictable using a airleak test (ALT) where a standardized test - measuring ETT leakage after deflating the ETT cuff- is performed once or multiple times just prior to extubation. Results have been contradictory to say the least (ref).
Based on current literature two questions arise. First; do we need to look at ETT leakage with a deflated - as is common practice in airleak tests - cuff? Or is the presence or absence of ETT leakage with an inflated cuff predictive for the development of PES? Second; airleak tests provide merely a snapshot -a trend measurement can possibly offer greater insight - especially using high resolution data. Would looking at the ETT leak trend for a longer period prior to extubation provide a clearer predictive value for the development of PES? The aim of our study is to answer these question and to determine if high resolution endotracheal tube leak data is predictive of the development of post-extubation stridor in children.
Analysis Airleak (% inspiratory tidal volume - expiratory tidal volume) will be calculated every minute in the 12 hours prior to extubation. Both magnitude (airleak %) and exposure (time) will be examined and plotted for patients with and without post-extubation stridor (primary outcome).
Primary outcome measures
- Post-Extubation Stridor [Time frame: during ICU admission]
Secondary outcome measures (3)
- Reintubation [Time frame: during ICU admission]
- Diagnostic procedure [Time frame: during ICU admission]
- Surgical airway [Time frame: during ICU admission]
Eligibility criteria
Inclusion criteria
- Age 0 - 16 years
- Ventilation via endotracheal tube for at least 6 hours
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Antwerp University Hospital — Antwerp
Publications
- Wratney AT, Benjamin DK Jr, Slonim AD, He J, Hamel DS, Cheifetz IM. The endotracheal tube air leak test does not predict extubation outcome in critically ill pediatric patients. Pediatr Crit Care Med. 2008 Sep;9(5):490-6. doi: 10.1097/PCC.0b013e3181849901. PMID 18679147
- Mhanna MJ, Zamel YB, Tichy CM, Super DM. The "air leak" test around the endotracheal tube, as a predictor of postextubation stridor, is age dependent in children. Crit Care Med. 2002 Dec;30(12):2639-43. doi: 10.1097/00003246-200212000-00005. PMID 12483052
- Kemper KJ, Benson MS, Bishop MJ. Predictors of postextubation stridor in pediatric trauma patients. Crit Care Med. 1991 Mar;19(3):352-5. doi: 10.1097/00003246-199103000-00012. PMID 1999096
- Jaber S, Chanques G, Matecki S, Ramonatxo M, Vergne C, Souche B, Perrigault PF, Eledjam JJ. Post-extubation stridor in intensive care unit patients. Risk factors evaluation and importance of the cuff-leak test. Intensive Care Med. 2003 Jan;29(1):69-74. doi: 10.1007/s00134-002-1563-4. Epub 2002 Nov 22. PMID 12528025
- Suominen PK, Tuominen NA, Salminen JT, Korpela RE, Klockars JG, Taivainen TR, Meretoja OA. The air-leak test is not a good predictor of postextubation adverse events in children undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2007 Apr;21(2):197-202. doi: 10.1053/j.jvca.2006.01.007. Epub 2006 Apr 19. PMID 17418731
- Schneider J, Mulale U, Yamout S, Pollard S, Silver P. Impact of monitoring endotracheal tube cuff leak pressure on postextubation stridor in children. J Crit Care. 2016 Dec;36:173-177. doi: 10.1016/j.jcrc.2016.06.033. Epub 2016 Jul 9. PMID 27546768
- Lacarra B, Hayotte A, Naudin J, Maroni A, Geslain G, Poncelet G, Levy M, Resche-Rigon M, Dauger S. Air leak test in the Paediatric Intensive Care Unit (ALTIPICU): rationale and protocol for a prospective multicentre observational study. BMJ Open. 2024 Apr 30;14(4):e081314. doi: 10.1136/bmjopen-2023-081314. PMID 38688666
Identifiers
NCT: NCT07414472 · Edge 004162