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

Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Jorinde Polderman, MD, PhD; Phone Number: +31205669111; Email: j.a.polderman@amsterdamumc.nl
• Study Contact Backup: Name: David van Meenen, MD, PhD; Phone Number: +31205669111; Email: d.m.vanmeenen@amsterdamumc.nl

Study Locations

• Australia
  • Perth, Australia
    • Not yet recruiting
    • Perth Children's Hospital
    • Contact: Britta Regli-Von Ungern-Sternberg, Prof; Email: Britta.Regli-VonUngern@health.wa.gov.au
• Italy
  • Genoa, Italy
    • Not yet recruiting
    • IRCCS Istituto Giannina Gaslini
    • Contact: Nicola Disma, MD, PhD; Email: nicoladisma@gmail.com
• Netherlands
  • Please Select
    • Amsterdam, Please Select, Netherlands, 1105AZ
      • Recruiting
      • Amsterdam University Medical Centers
      • Contact: Jorinde Polderman, MD, PhD; Email: j.a.polderman@amsterdamumc.nl
      • Contact: David van Meenen, MD, PhD; Email: d.m.vanmeenen@amsterdamumc.nl
      • Contact: Marcus Schultz, Prof
• Switzerland
  • Bern, Switzerland
    • Not yet recruiting
    • Universitätsspital Bern
    • Contact: Thomas Riva, MD, PhD; Email: thomasriva@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients undergoing general anesthesia

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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.
Infants; Infants of 1 month to 1 year old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
Toddlers; Toddlers of 1 to 3 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
Preschool; Children of preschool age 3 to 6 years old, undergoing general anaesthesia with mechanical ventilation. No intervention will be administered.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative pulmonary complications	incidence of postoperative pulmonary complications (PPCs) in the first five postoperative days. Definition of postoperative pulmonary complications: • Invasive mechanical ventilation after discharge from the operating room.; respiratory failure defined as: PaO2 < 8 kPa or SpO2< 90% despite oxygen therapy, with a need for non-invasive ventilation (NIV); unplanned oxygen therapy, including humidified high flow nasal oxygen (oxygen administered due to PaO2< 8 kPa or SpO2< 90% in room air; need for bronchodilators postoperatively in the PACU or at the ward;; pneumonia;; ARDS;; pneumothorax.	follow-up up to day 5 postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
type of ventilation mode	what type of ventilation mode is chosen	15 minutes after incision
Tidal volume (Vt)	average of three subsequent expiratory tidal volumes. In case expiratory volumes are unavailable, inspiratory tidal volumes are used.	15 minutes after incision
Peak inspiratory pressure or plateau pressure	Measured peak inspiratory or plateau pressure	15 minutes after incision
Level of pressure support above PEEP	Level of pressure support above PEEP, only in spontaneously breathing patients	15 minutes after incision
I:E ratio	I:E ratio or inspiratory time, measured in sec	15 minutes after incision
Respiratory rate	set and actual respiratory rate	15 minutes after incision
Compliance (Crs)	calculated compliance	15 minutes after incision
Driving pressure	calculated driving pressure	15 mintues after incision
Mechanical power	calculated mechanical power	15 minutes after incision
Intraoperative complications	intraoperative complications are defined as: oxygen desaturation (SpO2 < 90%), hypercapnia (etCO2 > 6.0), laryngospasm, bronchospasm, need for unplanned recruitment maneuvers, cardiac arrest.	during surgery
Length of hospital stay	total duration of stay in hospital, measured in days	follow-up up to day 5 postoperative
postoperative end-expiratory pressure (PEEP)	level of PEEP	15 minutes after incision
Inspiratory fraction of oxygen (FiO2)	measured inspiratory O2 fraction	15 minutes after incision
Saturation (SpO2)	measured SpO2	15 mintues after incision
end-tidal carbondioxide (etCO2)	measured etCO2	15 minutes after incision
Admittance to PICU or neonatal intensive care unit (NICU)	planned and unplanned admission to PICU or NICU	follow-up up to day 5 postoperative

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Marcus Schultz, Prof, Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): January 7, 2026

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: mechanical ventilation; pediatric anesthesia; postoperative pulmonary complications
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: C1_bigapple_V1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Authors of the publication will be team members of the steering committee who contributed to the design, conduct or analysis of the study and who approved of the final version of the manuscript, plus the BIG APPLE investigators. All participating investigators will be collaborator of this group and will be included on all publications from the BIG APPLE database. Local PIs agree not to individually publish or present the results they obtain from the participation in this multicenter study before the publication of the main results of the study. According to FAIR data principles, the pooled dataset will be available for all members of the BIG APPLE collaboration on request for secondary analyses after judgement and approval of scientific quality and validity by the Steering Committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No