Is High Resolution Endotracheal Tube Leak Data Indicative... | NCT07414472

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

NCT07414472

Sponsor

University Hospital, Antwerp

Status

Recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Post Extubation Stridor

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2025Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Feb 9, 2026

First Submission Date that Met QC Criteria

Feb 9, 2026

First Posted Date

Feb 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2026

Last Update Posted Date

Feb 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Reintubation	Need for reintubation	during ICU admission
Diagnostic procedure	Need for diagnostic procedure	during ICU admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Petra Vertongen	Contact	038214404		petra.vertongen@uza.be
leen Ameryckx	Contact	032757005		leen.ameryckx@uza.be

Overall Officials

Name	Affiliation	Role
Thomas Peros, Dr.	University Hospital, Antwerp	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antwerp University Hospital	Recruiting	Antwerp	Antwerp	2650	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18679147	Background	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.
12483052	Background	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.