Endotracheal tube leak patterns to predict post-extubation stridor in children
PES: Is High Resolution Endotracheal Tube Leak Data Indicative of the Development of Post-extubation Stridor in Children?
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 |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Antwerp, Antwerp) |
| Trial ID | NCT07414472 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 0 - 16 years * Ventilation via endotracheal tube for at least 6 hours Exclusion Criteria: * None
Where this trial is running
Antwerp, Antwerp
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.