Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06166706
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-12-04
Brief Title:
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIG APPLE
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
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 differencesvariations 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
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 differencesvariations 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None