a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
NCT05886387
Mechanical Ventilation Complication, Pathologic Processes
São Paulo, Brazil
View Trial DetailsNCT Number: NCT06166706
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.
Interested in participating?
Request InfoUp to 16 year
All sexes
Observational
Perth Children's Hospital, Perth, Australia
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
Time frame: 15 minutes after incision
what type of ventilation mode is chosen
Time frame: 15 minutes after incision
average of three subsequent expiratory tidal volumes. In case expiratory volumes are unavailable, inspiratory tidal volumes are used.
Time frame: 15 minutes after incision
level of PEEP
Time frame: 15 minutes after incision
Measured peak inspiratory or plateau pressure
Time frame: 15 minutes after incision
Level of pressure support above PEEP, only in spontaneously breathing patients
Time frame: 15 minutes after incision
measured inspiratory O2 fraction
Time frame: 15 minutes after incision
I:E ratio or inspiratory time, measured in sec
Time frame: 15 mintues after incision
measured SpO2
Time frame: 15 minutes after incision
measured etCO2
Time frame: 15 minutes after incision
set and actual respiratory rate
Time frame: 15 minutes after incision
calculated compliance
Time frame: 15 mintues after incision
calculated driving pressure
Time frame: 15 minutes after incision
calculated mechanical power
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.
Time frame: follow-up up to day 5 postoperative
total duration of stay in hospital, measured in days
Time frame: follow-up up to day 5 postoperative
planned and unplanned admission to PICU or NICU
Contact information is provided by the study sponsor or research team.
David van Meenen, MD, PhD
CONTACT
Jorinde Polderman, MD, PhD
CONTACT
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study
Acronym: BIG APPLE
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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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