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

October 2, 2019 updated by: Bruno Greff, St. Justine's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study aims at assessing cerebral blood flow (measured with Near-Infrared Reflectance Spectroscopy - NIRS - and transcranial Doppler - DTC) variations following end-tidal expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia performed according to standards of care.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
        • Sainte Justine's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main Arm
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
Controlled modification of EtCO2 through modification of ventilation parameters under general anesthesia without spontaneous breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIRS variation
Time Frame: 5 to 10 minutes
Near-Infrared Spectroscopy value variation after EtCO2 modification
5 to 10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DTC variation
Time Frame: 5 to 10 minutes
Transcranial Doppler values variation after EtCO2 modification
5 to 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Justine's Hospital

Investigators

  • Principal Investigator: Bruno Greff, MD, Sainte Justine's Hospital
  • Study Director: Ossam Rhondali, MD, Sainte Justine's Hospital
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2017

Primary Completion (Actual)

March 3, 2019

Study Completion (Actual)

March 3, 2019

Study Registration Dates

First Submitted

May 23, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • #2017-1309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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