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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07414472
Acronym
PES
Enrollment
400
Registered
2026-02-17
Start date
2025-06-30
Completion date
2026-06-30
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Extubation Stridor

Keywords

Pediatric, Post extubation stridor

Brief summary

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).

Interventions

None listed

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Post-Extubation Stridorduring ICU admission(PES, definition = requirement of nebulized adrenaline)

Secondary

MeasureTime frameDescription
Reintubationduring ICU admissionNeed for reintubation
Diagnostic procedureduring ICU admissionNeed for diagnostic procedure
Surgical airwayduring ICU admissionNeed for surgical airway

Countries

Belgium

Contacts

CONTACTPetra Vertongen
petra.vertongen@uza.be038214404
CONTACTleen Ameryckx
leen.ameryckx@uza.be032757005
PRINCIPAL_INVESTIGATORThomas Peros, Dr.

University Hospital, Antwerp

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026