Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia (BIG APPLE)

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

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06166706

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

10,000 participants in 5 patient groups

Neonates

Description:

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

Description:

Infants of 1 month to 1 year old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.

Toddlers

Description:

Toddlers of 1 to 3 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.

Preschool

Description:

Children of preschool age 3 to 6 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.

School-aged and adolescents

Description:

School aged children and adolescents of 6 to17 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.