Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia

NCT06166706 | Recruiting

• 1 other identifier: C1_bigapple_V1.2
• Study Type: observational
• Target: 10,000
• Locations: 4 countries
• Sites: 4

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.

Conditions

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

Keywords

pediatric anesthesia; postoperative pulmonary complications; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• type of ventilation mode

  15 minutes after incision

• Tidal volume (Vt)

  15 minutes after incision

• postoperative end-expiratory pressure (PEEP)

  15 minutes after incision

• Peak inspiratory pressure or plateau pressure

  15 minutes after incision

• Level of pressure support above PEEP

  15 minutes after incision

Study Arms (5)

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.

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients undergoing general anesthesia

You may qualify if:

• aged ≤ 16 years;
• undergoing general anesthesia
• airway management with tube or LMA; and
• connected to mechanical ventilator . minimum duration of procedure: 15 minutes

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Perth Children's Hospital

Perth, Australia

NOT YET RECRUITING

IRCCS Istituto Giannina Gaslini

Genoa, Italy

NOT YET RECRUITING

Amsterdam University Medical Centers

Amsterdam, Please Select, 1105AZ, Netherlands

RECRUITING

Universitatsspital Bern

Bern, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Postoperative Complications

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcus Schultz, Prof

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorinde Polderman, MD, PhD

CONTACT

+31205669111; j.a.polderman@amsterdamumc.nl

David van Meenen, MD, PhD

CONTACT

+31205669111; d.m.vanmeenen@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: January 29, 2024
• Primary Completion: December 30, 2025
• Study Completion: January 7, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

AU (1); CH (1); IT (1); NL (1)