Clinical trial NCT06166706: Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia
Official title: Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mechanical Ventilation Complication
Pediatric ALL
Pulmonary Complication
Perioperative/Postoperative Complications
Keywords: pediatric anesthesia
postoperative pulmonary complications
mechanical ventilation
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 10000
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing general anesthesia

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative pulmonary complications
timeFrame: follow-up up to day 5 postoperative
Secondary outcomes:
measure: type of ventilation mode
timeFrame: 15 minutes after incision
measure: Tidal volume (Vt)
timeFrame: 15 minutes after incision
measure: postoperative end-expiratory pressure (PEEP)
timeFrame: 15 minutes after incision
measure: Peak inspiratory pressure or plateau pressure
timeFrame: 15 minutes after incision
measure: Level of pressure support above PEEP
timeFrame: 15 minutes after incision
measure: Inspiratory fraction of oxygen (FiO2)
timeFrame: 15 minutes after incision
measure: I:E ratio
timeFrame: 15 minutes after incision
measure: Saturation (SpO2)
timeFrame: 15 mintues after incision
measure: end-tidal carbondioxide (etCO2)
timeFrame: 15 minutes after incision
measure: Respiratory rate
timeFrame: 15 minutes after incision
measure: Compliance (Crs)
timeFrame: 15 minutes after incision
measure: Driving pressure
timeFrame: 15 mintues after incision
measure: Mechanical power
timeFrame: 15 minutes after incision
measure: Intraoperative complications
timeFrame: during surgery
measure: Length of hospital stay
timeFrame: follow-up up to day 5 postoperative
measure: Admittance to PICU or neonatal intensive care unit (NICU)
timeFrame: follow-up up to day 5 postoperative
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Perth Children's Hospital
city: Genoa
country: Italy
facility: IRCCS Istituto Giannina Gaslini
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers
state: Please Select
city: Bern
country: Switzerland
facility: Universitatsspital Bern
Study officials:
affiliation: Amsterdam UMC
name: Marcus Schultz, Prof
role: PRINCIPAL_INVESTIGATOR
References: