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

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ClinicalTrials.gov Identifier: NCT03567031
Recruitment Status : Completed
First Posted : June 25, 2018
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Bruno Greff, St. Justine's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anesthesia, General Infant Procedure: EtCO2 modification Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Cerebral blood flow is measured in each patient at 3 different, controlled levels of end-tidal CO2
Masking: None (Open Label)
Masking Description: Patient is under general anesthesia
Primary Purpose: Basic Science
Official Title: Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : March 3, 2019
Actual Study Completion Date : March 3, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. NIRS variation [ Time Frame: 5 to 10 minutes ]
    Near-Infrared Spectroscopy value variation after EtCO2 modification


Secondary Outcome Measures :
  1. DTC variation [ Time Frame: 5 to 10 minutes ]
    Transcranial Doppler values variation after EtCO2 modification


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567031


Locations
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Canada, Quebec
Sainte Justine's Hospital
Montréal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
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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 Documents (Full-Text)

Documents provided by Bruno Greff, St. Justine's Hospital:
Study Protocol and Informed Consent Form  [PDF] September 13, 2016

More Information
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Responsible Party: Bruno Greff, Principal Investigator, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03567031     History of Changes
Other Study ID Numbers: #2017-1309
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bruno Greff, St. Justine's Hospital:
Pediatric Anesthesia
Near-Infrared Spectroscopy
End-Tidal CO2
Cerebral Blood Flow
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs