Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia
NCT ID: NCT06166706
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2024-01-29
2026-01-07
Brief Summary
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Detailed Description
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Objective
The aims of this study are to:
* determine the incidence of PPCs in pediatric patients;
* describe the practice of ventilatory support in children undergoing general anesthesia;
* describe geo-economic differences/variations in ventilatory support and development of PPCs in children undergoing general anesthesia;
* identify potentially modifiable factors that have independent associations with development of PPCs, hospital length of stay and pediatric intensive care unit (PICU) admittance; and
* develop a risk score for the development of PPCs comparable to the ARISCAT score.
Study design Multicenter international observational cohort study. Study population Patients ≤16 years of age undergoing invasive ventilation for general anesthesia in the operating room.
Main study endpoints The primary endpoint is the incidence of PPCs. Secondary outcomes are the ventilator settings, ventilation parameters, length of hospital stay and PICU admittance.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Infants
Infants of 1 month to 1 year old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
No interventions assigned to this group
Toddlers
Toddlers of 1 to 3 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
No interventions assigned to this group
Preschool
Children of preschool age 3 to 6 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* undergoing general anesthesia
* airway management with tube or LMA; and
* connected to mechanical ventilator . minimum duration of procedure: 15 minutes
Exclusion Criteria
* 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.
16 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Jorinde Polderman
Principal Investigator
Principal Investigators
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Marcus Schultz, Prof
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC
Locations
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Perth Children's Hospital
Perth, , Australia
IRCCS Istituto Giannina Gaslini
Genoa, , Italy
Amsterdam University Medical Centers
Amsterdam, Please Select, Netherlands
Universitatsspital Bern
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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C1_bigapple_V1.2
Identifier Type: -
Identifier Source: org_study_id
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