Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia

NCT03567031 | Completed

• 1 other identifier: #2017-1309
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims at assessing cerebral blood flow variations following expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia.

Conditions

Anesthesia, General; Infant

Keywords

Pediatric Anesthesia; Near-Infrared Spectroscopy; End-Tidal CO2; Cerebral Blood Flow

Outcome Measures

Primary Outcomes (1)

• NIRS variation

  Near-Infrared Spectroscopy value variation after EtCO2 modification

  5 to 10 minutes

Secondary Outcomes (1)

• DTC variation

  5 to 10 minutes

Study Arms (1)

Main Arm

EXPERIMENTAL

In each patient, under ongoing standard general anesthesia in a stable state, EtCO2 is manually modified to reach predefined values, and after waiting until cerebral blood flow has reached steady state, NIRS and DTC values are noted.

Procedure: EtCO2 modification

Interventions

EtCO2 modification PROCEDURE

Controlled modification of EtCO2 through modification of ventilation parameters under general anesthesia without spontaneous breathing

Main Arm

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age \< or = 6 months
• ASA class \< or = 3
• General anesthesia required for surgery

You may not qualify if:

• No parental consent
• Emergency surgery
• Preexisting neurological condition
• Hemodynamic instability
• Preexisting hypoxemia and/or hypercapnia
• Laparoscopy or thoracoscopy, if expected EtCO2 level achieving would require unsafe ventilation parameters

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

Sainte Justine's Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

Study Officials

• Bruno Greff, MD

  Sainte Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Ossam Rhondali, MD

  Sainte Justine's Hospital

  STUDY DIRECTOR

• Jose Luis Martinez, MD

  Sainte Justine's Hospital

  STUDY CHAIR

• Chantal Crochetière, MD

  Sainte Justine's Hospital

  STUDY CHAIR

• Valérie Gaspard, MD

  Sainte Justine's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patient is under general anesthesia
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cerebral blood flow is measured in each patient at 3 different, controlled levels of end-tidal CO2

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 25, 2018
• Study Start: November 27, 2017
• Primary Completion: March 3, 2019
• Study Completion: March 3, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)