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NCT Number: NCT07414472

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.

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Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Post-Extubation Stridor

    Time frame: during ICU admission

    (PES, definition = requirement of nebulized adrenaline)

Secondary outcomes

  1. Reintubation

    Time frame: during ICU admission

    Need for reintubation

  2. Diagnostic procedure

    Time frame: during ICU admission

    Need for diagnostic procedure

  3. Surgical airway

    Time frame: during ICU admission

    Need for surgical airway

Study contacts

Contact information is provided by the study sponsor or research team.

Petra Vertongen

CONTACT

[email protected]

038214404

leen Ameryckx

CONTACT

[email protected]

032757005

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Acronym: PES

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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