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Recruiting NCT06166706

Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia

Conditions: Mechanical Ventilation Complication Pediatric ALL Pulmonary Complication Perioperative/Postoperative Complications

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

trial.available_in: БГ
Overview
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.
Description
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.
Who can participate
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.
Locations 4
Australia (1)
Perth Children's Hospital
Perth
NOT_YET_RECRUITING
Britta Regli-Von Ungern-Sternberg, Prof
Italy (1)
IRCCS Istituto Giannina Gaslini
Genoa
NOT_YET_RECRUITING
Nicola Disma, MD, PhD
Netherlands (1)
Amsterdam University Medical Centers
Amsterdam , Please Select
Jorinde Polderman, MD, PhD
Switzerland (1)
Universitatsspital Bern
Bern
NOT_YET_RECRUITING
Thomas Riva, MD, PhD
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Maximum age
16 Years
Healthy volunteers
No
Start date
29.01.2024
Completion date
07.01.2026
Registry ID
NCT06166706
Source
anzctr
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