Endotracheal tube leak patterns to predict post-extubation stridor in children
Official title: PES: Is High Resolution Endotracheal Tube Leak Data Indicative of the Development of Post-extubation Stridor in Children?
Run by University Hospital, Antwerp · NCT07414472 · Data updated 2026-11-12
This project will test whether detailed leak measurements from a child's breathing tube can help predict who will develop noisy breathing (post-extubation stridor) after the tube is removed.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 16 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Antwerp, Antwerp) |
| Status | Recruiting |
| Started | June 30, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07414472 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 0–16 who have been ventilated through an endotracheal tube for at least six hours in the PICU and are undergoing planned extubation are ideal candidates.
✕Probably not a fit
Children who are not intubated, who have a tracheostomy, or who undergo emergency unplanned extubation are unlikely to benefit from this monitoring approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will collect high-resolution endotracheal tube (ETT) leak data from children in the pediatric intensive care unit and follow them through extubation to record any occurrence of post-extubation stridor (PES). Investigators will compare leak presence with both inflated and deflated cuffs and analyze leak trends over time rather than single snapshot measurements. The study includes children aged 0–16 who have been ventilated via an ETT for at least six hours and will be conducted at Antwerp University Hospital. No interventions are performed; clinical care proceeds per usual practice while data are recorded.
Why it matters
Potential benefit: If successful, clinicians could use pre-extubation leak patterns to identify children at higher risk of stridor and intervene earlier to reduce respiratory distress and the need for re-intubation.
How similar studies have gone: Prior single-point air-leak tests have given mixed results, and continuous high-resolution leak-trend analysis is a relatively new approach with limited prior validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 0 - 16 years * Ventilation via endotracheal tube for at least 6 hours Exclusion Criteria: * None
Where it's running
-
Antwerp University Hospital
Antwerp, Antwerp, Belgium Recruiting
Study contacts
- Principal investigator: Thomas Peros, Dr. — University Hospital, Antwerp
- Study coordinator: Petra Vertongen
- Email: petra.vertongen@uza.be
- Phone: 038214404
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.