Mechanical Ventilation ComplicationBIG APPLENCT06166706
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia
An observational study of Mechanical Ventilation Complication and Pediatric ALL, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Mechanical Ventilation Complication, Pediatric ALL, Pulmonary Complication
- How many people
- 10,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 29 Jan 2024to 7 Jan 2026
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients undergoing general anesthesia
Who may be able to join
- aged ≤ 16 years;
- undergoing general anesthesia
- airway management with tube or LMA; and
- connected to mechanical ventilator . minimum duration of procedure: 15 minutes
Who cannot join
- 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 locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Australia1 site, 1 recruiting
- Not yet recruiting
Perth Children's Hospital
Perth
Britta Regli-Von Ungern-Sternberg, Prof, Britta.Regli-VonUngern@health.wa.gov.au
Italy1 site, 1 recruiting
- Not yet recruiting
IRCCS Istituto Giannina Gaslini
Genoa
Nicola Disma, MD, PhD, nicoladisma@gmail.com
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Centers
Amsterdam, Please Select, 1105AZ
Jorinde Polderman, MD, PhD, j.a.polderman@amsterdamumc.nl
David van Meenen, MD, PhD, d.m.vanmeenen@amsterdamumc.nl
Switzerland1 site, 1 recruiting
- Not yet recruiting
Universitatsspital Bern
Bern
Thomas Riva, MD, PhD, thomasriva@me.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Mechanical Ventilation Complication, Pediatric ALL, Pulmonary Complication, Perioperative/Postoperative Complications
- Keywords
- pediatric anesthesia, postoperative pulmonary complications, mechanical ventilation
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: follow-up up to day 5 postoperative
Secondary outcomes (16)
type of ventilation mode
what type of ventilation mode is chosen
Measured: 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.
Measured: 15 minutes after incision
postoperative end-expiratory pressure (PEEP)
level of PEEP
Measured: 15 minutes after incision
Peak inspiratory pressure or plateau pressure
Measured peak inspiratory or plateau pressure
Measured: 15 minutes after incision
Level of pressure support above PEEP
Level of pressure support above PEEP, only in spontaneously breathing patients
Measured: 15 minutes after incision
Inspiratory fraction of oxygen (FiO2)
measured inspiratory O2 fraction
Measured: 15 minutes after incision
I:E ratio
I:E ratio or inspiratory time, measured in sec
Measured: 15 minutes after incision
Saturation (SpO2)
measured SpO2
Measured: 15 mintues after incision
end-tidal carbondioxide (etCO2)
measured etCO2
Measured: 15 minutes after incision
Respiratory rate
set and actual respiratory rate
Measured: 15 minutes after incision
Compliance (Crs)
calculated compliance
Measured: 15 minutes after incision
Driving pressure
calculated driving pressure
Measured: 15 mintues after incision
Mechanical power
calculated mechanical power
Measured: 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.
Measured: during surgery
Length of hospital stay
total duration of stay in hospital, measured in days
Measured: follow-up up to day 5 postoperative
Admittance to PICU or neonatal intensive care unit (NICU)
planned and unplanned admission to PICU or NICU
Measured: follow-up up to day 5 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start29 Jan 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion7 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorinde Polderman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marcus Schultz, Prof, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166706
- Sponsor's protocol ID
- C1_bigapple_V1.2
- Acronym
- BIG APPLE
- Status last verified
- Apr 2025
- First submitted
- 4 Dec 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06166706
- Acronym / sponsor ID
- BIG APPLE / C1_bigapple_V1.2
- Conditions
- Mechanical Ventilation Complication, Pediatric ALL, Pulmonary Complication, Perioperative/Postoperative Complications
- Keywords
- pediatric anesthesia, postoperative pulmonary complications, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 7 Jan 2026 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients undergoing general anesthesia
Key inclusion criteria (4 listed)
- aged ≤ 16 years;
- undergoing general anesthesia
- airway management with tube or LMA; and
- connected to mechanical ventilator . minimum duration of procedure: 15 minutes
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
16 secondary outcomes
type of ventilation mode
Time frame: 15 minutes after incision
Tidal volume (Vt)
Time frame: 15 minutes after incision
postoperative end-expiratory pressure (PEEP)
Time frame: 15 minutes after incision
Peak inspiratory pressure or plateau pressure
Time frame: 15 minutes after incision
Level of pressure support above PEEP
Time frame: 15 minutes after incision
Inspiratory fraction of oxygen (FiO2)
Time frame: 15 minutes after incision
I:E ratio
Time frame: 15 minutes after incision
Saturation (SpO2)
Time frame: 15 mintues after incision
end-tidal carbondioxide (etCO2)
Time frame: 15 minutes after incision
Respiratory rate
Time frame: 15 minutes after incision
Compliance (Crs)
Time frame: 15 minutes after incision
Driving pressure
Time frame: 15 mintues after incision
Mechanical power
Time frame: 15 minutes after incision
Intraoperative complications
Time frame: during surgery
Length of hospital stay
Time frame: follow-up up to day 5 postoperative
Admittance to PICU or neonatal intensive care unit (NICU)
Time frame: follow-up up to day 5 postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcus Schultz, Prof principal investigator
Amsterdam UMC
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication and Pediatric ALL, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, Italy, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorinde Polderman, MD, PhD (+31205669111, j.a.polderman@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative pulmonary complications (time frame: follow-up up to day 5 postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.