Observing Breathing Machine Settings in Children Having General Anesthesia
Studies how children under 16 are ventilated during surgery and lung complications afterward.
Key facts
- Who runs it
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Where
- Genoa, ItalySee the siteAlso in 3 other countries, 3 sites
- Trial code
- Registry title
- Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia
- Status
- Recruiting
- People taking part
- 10,000 people, planned
- Started
- 29 Jan 2024
- Planned end
- 7 Jan 2026
- Type of study
- Observational, 5 groups
- Record updated
- 9 April 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children up to 16 years old who are having general anesthesia and are connected to a breathing machine. It studies how the machine is set and lung problems after surgery.
- Age
- Up to 16 years
- Sex
- All sexes can join
Main reasons for not taking part
- Surgery that uses a heart-lung machine (extra-corporal circulation)
- High frequency jet or high frequency oscillatory ventilation
- Sedation without a breathing tube or airway device
- Rigid bronchoscopy where the child keeps breathing on their own
- Procedure shorter than 15 minutes
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- aged ≤ 16 years
- undergoing general anesthesia
- airway management with tube or LMA; and
- connected to mechanical ventilator . minimum duration of procedure: 15 minutes
Who cannot take part
- 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 in Italy
Also in 3 other countries, 3 sites
- IRCCS Istituto Giannina GasliniGenoa, ItalyContact: Nicola Disma, MD, PhDNot yet recruiting
About the trial
What the trial wants to find out
Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.
The 5 groups in the trial
- Neonates
neonates up to 44 weeks postmenstrual age or up to 60 weeks post menstrual age if born premature (GA \<37 weeks) undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
- Infants
Infants of 1 month to 1 year old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
- Toddlers
Toddlers of 1 to 3 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
- Preschool
Children of preschool age 3 to 6 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
- School-aged and adolescents
School aged children and adolescents of 6 to17 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study
- Plain-language title
- Observing Breathing Machine Settings in Children Having General AnesthesiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 9 April 2025