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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
30/01/2024

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
Timepoint [1] 0 0
follow-up up to day 5 postoperative
Secondary outcome [1] 0 0
type of ventilation mode
Timepoint [1] 0 0
15 minutes after incision
Secondary outcome [2] 0 0
Tidal volume (Vt)
Timepoint [2] 0 0
15 minutes after incision
Secondary outcome [3] 0 0
postoperative end-expiratory pressure (PEEP)
Timepoint [3] 0 0
15 minutes after incision
Secondary outcome [4] 0 0
Peak inspiratory pressure or plateau pressure
Timepoint [4] 0 0
15 minutes after incision
Secondary outcome [5] 0 0
Level of pressure support above PEEP
Timepoint [5] 0 0
15 minutes after incision
Secondary outcome [6] 0 0
Inspiratory fraction of oxygen (FiO2)
Timepoint [6] 0 0
15 minutes after incision
Secondary outcome [7] 0 0
I:E ratio
Timepoint [7] 0 0
15 minutes after incision
Secondary outcome [8] 0 0
Saturation (SpO2)
Timepoint [8] 0 0
15 mintues after incision
Secondary outcome [9] 0 0
end-tidal carbondioxide (etCO2)
Timepoint [9] 0 0
15 minutes after incision
Secondary outcome [10] 0 0
Respiratory rate
Timepoint [10] 0 0
15 minutes after incision
Secondary outcome [11] 0 0
Compliance (Crs)
Timepoint [11] 0 0
15 minutes after incision
Secondary outcome [12] 0 0
Driving pressure
Timepoint [12] 0 0
15 mintues after incision
Secondary outcome [13] 0 0
Mechanical power
Timepoint [13] 0 0
15 minutes after incision
Secondary outcome [14] 0 0
Intraoperative complications
Timepoint [14] 0 0
during surgery
Secondary outcome [15] 0 0
Length of hospital stay
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)
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
7/05/2025
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)
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06166706
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marcus Schultz, Prof
Address 0 0
Amsterdam UMC
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06166706