Is High Resolution Endotracheal Tube Leak Data Indicative of the Development of Post-extubation Stridor in Children? (PES)

PES: Is High Resolution Endotracheal Tube Leak Data Indicative of the Development of Post-extubation Stridor in Children?

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.

Study Overview

• Status: Recruiting
• Conditions: Post Extubation Stridor

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).

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Petra Vertongen; Phone Number: 038214404; Email: petra.vertongen@uza.be
• Study Contact Backup: Name: leen Ameryckx; Phone Number: 032757005; Email: leen.ameryckx@uza.be

Study Locations

• Belgium
  • Antwerp
    • Antwerp, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital
      • Contact: Petra Vertongen; Phone Number: +32 38214404; Email: petra.vertongen@uza.be
      • Contact: Leen Ameryckx; Phone Number: +32 3 2757005; Email: leen.ameryckx@uza.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All ventilated children under 16 years will be eligible for thus study

Description

Inclusion Criteria:

• Age 0 - 16 years
• Ventilation via endotracheal tube for at least 6 hours

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Extubation Stridor	(PES, definition = requirement of nebulized adrenaline)	during ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintubation	Need for reintubation	during ICU admission
Diagnostic procedure	Need for diagnostic procedure	during ICU admission
Surgical airway	Need for surgical airway	during ICU admission

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Thomas Peros, Dr., University Hospital, Antwerp

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric; Post extubation stridor
• Other Study ID Numbers: Edge 004162

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No