Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia

NCT ID: NCT06166706

Last Updated: 2025-04-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-29

Study Completion Date

2026-01-07

Brief Summary

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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.

Detailed Description

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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.

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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Mechanical Ventilation Complication Pediatric ALL Pulmonary Complication Perioperative/Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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.
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Jorinde Polderman

Principal Investigator

Responsibility Role 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

Site Status NOT_YET_RECRUITING

IRCCS Istituto Giannina Gaslini

Genoa, , Italy

Site Status NOT_YET_RECRUITING

Amsterdam University Medical Centers

Amsterdam, Please Select, Netherlands

Site Status RECRUITING

Universitatsspital Bern

Bern, , Switzerland

Site Status NOT_YET_RECRUITING

Countries

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Australia Italy Netherlands Switzerland

Central Contacts

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Jorinde Polderman, MD, PhD

Role: CONTACT

+31205669111

David van Meenen, MD, PhD

Role: CONTACT

+31205669111

Facility Contacts

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Britta Regli-Von Ungern-Sternberg, Prof

Role: primary

Nicola Disma, MD, PhD

Role: primary

Jorinde Polderman, MD, PhD

Role: primary

David van Meenen, MD, PhD

Role: backup

Thomas Riva, MD, PhD

Role: primary

Other Identifiers

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C1_bigapple_V1.2

Identifier Type: -

Identifier Source: org_study_id

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