Actively Recruiting
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-04-09
10000
Participants Needed
4
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand the use of mechanical ventilation during general anesthesia in children aged 16 years and younger. It focuses on how different ventilation settings may relate to the development of postoperative pulmonary complications (PPCs), which are common and can lead to longer hospital stays and increased costs. The study addresses the current lack of guidance and variation in ventilation practices for pediatric patients undergoing surgery. The study is an international, multicenter observational cohort where no treatment interventions are given. It includes children from neonates to adolescents who are mechanically ventilated during general anesthesia. Researchers will observe ventilator settings such as mode, tidal volume, pressure, oxygen levels, and ventilation parameters 15 minutes after incision, as well as monitor any complications during surgery. Participants will be followed up to five days after surgery to assess the occurrence of PPCs, length of hospital stay, and any admission to pediatric or neonatal intensive care units. The study will collect detailed data on ventilation practices and patient outcomes to identify factors linked to complications and to develop a risk score for PPCs. This information may help improve care and reduce lung complications after surgery in children.
CONDITIONS
Brief Title
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 16 years or younger
- Undergoing general anesthesia
- Airway managed with a tube or supraglottic airway device
- Connected to a mechanical ventilator
- Procedure expected to last at least 15 minutes
You will not qualify if you...
- Undergoing surgical procedures involving extracorporeal circulation
- Receiving high frequency jet or oscillatory ventilation
- Sedation without airway management using endotracheal tube or supraglottic airway device
- Undergoing rigid bronchoscopic procedures with spontaneous ventilation maintained
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgery (at least 15 minutes)
Participants undergoing general anesthesia with mechanical ventilation are observed during surgery to collect data on ventilator settings and intraoperative parameters.
1 visit during surgery
Duration - Up to 5 days postoperative
Participants are followed for up to 5 days after surgery to observe postoperative pulmonary complications, length of hospital stay, and admittance to intensive care units.
Daily assessments for up to 5 days
Trial Site Locations
Total: 4 locations
1
Perth Children's Hospital
Perth, Australia
Not Yet Recruiting
2
IRCCS Istituto Giannina Gaslini
Genoa, Italy
Not Yet Recruiting
3
Amsterdam University Medical Centers
Amsterdam, Please Select, Netherlands, 1105AZ
Actively Recruiting
4
Universitatsspital Bern
Bern, Switzerland
Not Yet Recruiting
Research Team
J
Jorinde Polderman, MD, PhD
D
David van Meenen, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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