Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia

Mechanical Ventilation Complication Clinical Trial

— BIG APPLE  

Official title:

Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166706
• Other study ID #: C1_bigapple_V1.2
• Status: Recruiting
• Start date: January 29, 2024
• Est. completion date: May 7, 2025

Study information

• Verified date: January 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Jorinde Polderman, MD, PhD
• Phone: +31205669111
• Email: j.a.polderman[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: May 7, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

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.

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Pediatric ALL
• Perioperative/Postoperative Complications
• Postoperative Complications
• Pulmonary Complication

Locations

Country	Name	City	State
Australia	Perth Children's Hospital	Perth
Italy	IRCCS Istituto Giannina Gaslini	Genoa
Netherlands	Amsterdam University Medical Centers	Amsterdam	Please Select
Switzerland	Universitatsspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Countries where clinical trial is conducted

Australia,  Italy,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	follow-up up to day 5 postoperative
Secondary	type of ventilation mode	what type of ventilation mode is chosen	15 minutes after incision
Secondary	Tidal volume (Vt)	average of three subsequent expiratory tidal volumes. In case expiratory volumes are unavailable, inspiratory tidal volumes are used.	15 minutes after incision
Secondary	postoperative end-expiratory pressure (PEEP)	level of PEEP	15 minutes after incision
Secondary	Peak inspiratory pressure or plateau pressure	Measured peak inspiratory or plateau pressure	15 minutes after incision
Secondary	Level of pressure support above PEEP	Level of pressure support above PEEP, only in spontaneously breathing patients	15 minutes after incision
Secondary	Inspiratory fraction of oxygen (FiO2)	measured inspiratory O2 fraction	15 minutes after incision
Secondary	I:E ratio	I:E ratio or inspiratory time, measured in sec	15 minutes after incision
Secondary	Saturation (SpO2)	measured SpO2	15 mintues after incision
Secondary	end-tidal carbondioxide (etCO2)	measured etCO2	15 minutes after incision
Secondary	Respiratory rate	set and actual respiratory rate	15 minutes after incision
Secondary	Compliance (Crs)	calculated compliance	15 minutes after incision
Secondary	Driving pressure	calculated driving pressure	15 mintues after incision
Secondary	Mechanical power	calculated mechanical power	15 minutes after incision
Secondary	Intraoperative complications	intraoperative complications are defined as: oxygen desaturation (SpO2 < 90%), hypercapnia (etCO2 > 6.0), laryngospasm, bronchospasm, need for unplanned recruitment maneuvers, cardiac arrest.	during surgery
Secondary	Length of hospital stay	total duration of stay in hospital, measured in days	follow-up up to day 5 postoperative
Secondary	Admittance to PICU or neonatal intensive care unit (NICU)	planned and unplanned admission to PICU or NICU	follow-up up to day 5 postoperative