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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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