Evaluating ventilation practices in children during general anesthesia
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06166706
This study looks at how children are helped to breathe during surgery to see if different methods affect their recovery and the chance of complications afterwards.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 4 sites (Perth and 3 other locations) |
| Trial ID | NCT06166706 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the current practices of mechanical ventilation in children undergoing general anesthesia, focusing on the incidence of postoperative pulmonary complications (PPCs). It will gather data from multiple international centers to describe ventilatory support practices and identify factors associated with PPCs, hospital length of stay, and pediatric intensive care unit (PICU) admissions. The study will also explore geo-economic variations in these practices and develop a risk score for PPCs similar to the ARISCAT score.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 16 years or younger who are undergoing general anesthesia with invasive ventilation.
Not a fit: Patients undergoing procedures involving extra-corporeal circulation or those receiving non-invasive ventilation methods may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved ventilation strategies that reduce the incidence of postoperative pulmonary complications in children.
How similar studies have performed: While studies on adult ventilation strategies have shown success, this specific approach in pediatric populations is less explored and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged ≤ 16 years; * undergoing general anesthesia * airway management with tube or LMA; and * connected to mechanical ventilator . minimum duration of procedure: 15 minutes Exclusion Criteria: * patients undergoing surgical procedures involving extra-corporal circulation; * patients receiving ventilation with high frequency jet ventilation or high frequency oscillatory ventilation; * sedation without airway management in the form of a endotracheal tube or a supraglottic airway device; and * (rigid) bronchoscopic procedures with maintenance of spontaneous ventilation.
Where this trial is running
Perth and 3 other locations
- Perth Children's Hospital — Perth, Australia (NOT_YET_RECRUITING)
- IRCCS Istituto Giannina Gaslini — Genoa, Italy (NOT_YET_RECRUITING)
- Amsterdam University Medical Centers — Amsterdam, Please Select, Netherlands (RECRUITING)
- Universitatsspital Bern — Bern, Switzerland (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Marcus Schultz, Prof — Amsterdam UMC
- Study coordinator: Jorinde Polderman, MD, PhD
- Email: j.a.polderman@amsterdamumc.nl
- Phone: +31205669111
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.
Conditions: Mechanical Ventilation Complication, Pediatric ALL, Pulmonary Complication, Perioperative/Postoperative Complications, pediatric anesthesia, postoperative pulmonary complications, mechanical ventilation