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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06166706




Registration number
NCT06166706
Ethics application status
Date submitted
4/12/2023
Date registered
12/12/2023
Date last updated
9/04/2025

Titles & IDs
Public title
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia
Scientific title
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study
Secondary ID [1] 0 0
C1_bigapple_V1.2
Universal Trial Number (UTN)
Trial acronym
BIG APPLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical Ventilation Complication 0 0
Pediatric ALL 0 0
Pulmonary Complication 0 0
Perioperative/Postoperative Complications 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of postoperative pulmonary complications
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
follow-up up to day 5 postoperative
Secondary outcome [1] 0 0
type of ventilation mode
Assessment method [1] 0 0
what type of ventilation mode is chosen
Timepoint [1] 0 0
15 minutes after incision
Secondary outcome [2] 0 0
Tidal volume (Vt)
Assessment method [2] 0 0
average of three subsequent expiratory tidal volumes. In case expiratory volumes are unavailable, inspiratory tidal volumes are used.
Timepoint [2] 0 0
15 minutes after incision
Secondary outcome [3] 0 0
postoperative end-expiratory pressure (PEEP)
Assessment method [3] 0 0
level of PEEP
Timepoint [3] 0 0
15 minutes after incision
Secondary outcome [4] 0 0
Peak inspiratory pressure or plateau pressure
Assessment method [4] 0 0
Measured peak inspiratory or plateau pressure
Timepoint [4] 0 0
15 minutes after incision
Secondary outcome [5] 0 0
Level of pressure support above PEEP
Assessment method [5] 0 0
Level of pressure support above PEEP, only in spontaneously breathing patients
Timepoint [5] 0 0
15 minutes after incision
Secondary outcome [6] 0 0
Inspiratory fraction of oxygen (FiO2)
Assessment method [6] 0 0
measured inspiratory O2 fraction
Timepoint [6] 0 0
15 minutes after incision
Secondary outcome [7] 0 0
I:E ratio
Assessment method [7] 0 0
I:E ratio or inspiratory time, measured in sec
Timepoint [7] 0 0
15 minutes after incision
Secondary outcome [8] 0 0
Saturation (SpO2)
Assessment method [8] 0 0
measured SpO2
Timepoint [8] 0 0
15 mintues after incision
Secondary outcome [9] 0 0
end-tidal carbondioxide (etCO2)
Assessment method [9] 0 0
measured etCO2
Timepoint [9] 0 0
15 minutes after incision
Secondary outcome [10] 0 0
Respiratory rate
Assessment method [10] 0 0
set and actual respiratory rate
Timepoint [10] 0 0
15 minutes after incision
Secondary outcome [11] 0 0
Compliance (Crs)
Assessment method [11] 0 0
calculated compliance
Timepoint [11] 0 0
15 minutes after incision
Secondary outcome [12] 0 0
Driving pressure
Assessment method [12] 0 0
calculated driving pressure
Timepoint [12] 0 0
15 mintues after incision
Secondary outcome [13] 0 0
Mechanical power
Assessment method [13] 0 0
calculated mechanical power
Timepoint [13] 0 0
15 minutes after incision
Secondary outcome [14] 0 0
Intraoperative complications
Assessment method [14] 0 0
intraoperative complications are defined as: oxygen desaturation (SpO2 \< 90%), hypercapnia (etCO2 \> 6.0), laryngospasm, bronchospasm, need for unplanned recruitment maneuvers, cardiac arrest.
Timepoint [14] 0 0
during surgery
Secondary outcome [15] 0 0
Length of hospital stay
Assessment method [15] 0 0
total duration of stay in hospital, measured in days
Timepoint [15] 0 0
follow-up up to day 5 postoperative
Secondary outcome [16] 0 0
Admittance to PICU or neonatal intensive care unit (NICU)
Assessment method [16] 0 0
planned and unplanned admission to PICU or NICU
Timepoint [16] 0 0
follow-up up to day 5 postoperative

Eligibility
Key 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
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/01/2026
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Genoa
Country [2] 0 0
Netherlands
State/province [2] 0 0
Please Select
Country [3] 0 0
Switzerland
State/province [3] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Marcus Schultz, Prof
Address 0 0
Amsterdam UMC
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jorinde Polderman, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+31205669111
Email 0 0
j.a.polderman@amsterdamumc.nl
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06166706