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NCT Number: NCT06166706

Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia

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.

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Key information

About this 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.

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of postoperative pulmonary complications

    Time frame: follow-up up to day 5 postoperative

    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.

Secondary outcomes

  1. type of ventilation mode

    Time frame: 15 minutes after incision

    what type of ventilation mode is chosen

  2. Tidal volume (Vt)

    Time frame: 15 minutes after incision

    average of three subsequent expiratory tidal volumes. In case expiratory volumes are unavailable, inspiratory tidal volumes are used.

  3. postoperative end-expiratory pressure (PEEP)

    Time frame: 15 minutes after incision

    level of PEEP

  4. Peak inspiratory pressure or plateau pressure

    Time frame: 15 minutes after incision

    Measured peak inspiratory or plateau pressure

  5. Level of pressure support above PEEP

    Time frame: 15 minutes after incision

    Level of pressure support above PEEP, only in spontaneously breathing patients

  6. Inspiratory fraction of oxygen (FiO2)

    Time frame: 15 minutes after incision

    measured inspiratory O2 fraction

  7. I:E ratio

    Time frame: 15 minutes after incision

    I:E ratio or inspiratory time, measured in sec

  8. Saturation (SpO2)

    Time frame: 15 mintues after incision

    measured SpO2

  9. end-tidal carbondioxide (etCO2)

    Time frame: 15 minutes after incision

    measured etCO2

  10. Respiratory rate

    Time frame: 15 minutes after incision

    set and actual respiratory rate

  11. Compliance (Crs)

    Time frame: 15 minutes after incision

    calculated compliance

  12. Driving pressure

    Time frame: 15 mintues after incision

    calculated driving pressure

  13. Mechanical power

    Time frame: 15 minutes after incision

    calculated mechanical power

  14. Intraoperative complications

    Time frame: during surgery

    intraoperative complications are defined as: oxygen desaturation (SpO2 < 90%), hypercapnia (etCO2 > 6.0), laryngospasm, bronchospasm, need for unplanned recruitment maneuvers, cardiac arrest.

  15. Length of hospital stay

    Time frame: follow-up up to day 5 postoperative

    total duration of stay in hospital, measured in days

  16. Admittance to PICU or neonatal intensive care unit (NICU)

    Time frame: follow-up up to day 5 postoperative

    planned and unplanned admission to PICU or NICU

Study contacts

Contact information is provided by the study sponsor or research team.

David van Meenen, MD, PhD

CONTACT

[email protected]

+31205669111

Jorinde Polderman, MD, PhD

CONTACT

[email protected]

+31205669111

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: BIG APPLE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 12, 2023
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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