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CompletedNCT03567031Updated Oct 3, 2019

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

An interventional study of EtCO2 modification in Anesthesia, General and Infant, sponsored by St. Justine's Hospital. Completed at 1 site in Canada. Open to participants aged Up to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-03.

Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2017, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
Up to 6 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia, General
  • Infant

Keywords

  • Pediatric Anesthesia
  • Near-Infrared Spectroscopy
  • End-Tidal CO2
  • Cerebral Blood Flow
03

In context

Lead sponsor

St. Justine's Hospital is the lead sponsor of 155 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureEtCO2 modification

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

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What researchers measure

Primary outcomes

  1. NIRS variation

    Near-Infrared Spectroscopy value variation after EtCO2 modification

    Time frame: 5 to 10 minutes

Secondary outcomes

  1. DTC variation

    Transcranial Doppler values variation after EtCO2 modification

    Time frame: 5 to 10 minutes

07

Study locations

1 site
  • Sainte Justine's Hospital
    Montréal, Quebec H3T 1C5, Canada
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References and documents

Study documents

  • Protocol and informed consent form · Sep 13, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03567031
Lead sponsor
St. Justine's Hospital
Responsible party
Bruno Greff (Principal Investigator, St. Justine's Hospital) — Principal investigator
First posted
Jun 25, 2018
Start date
Nov 27, 2017
Primary completion
Mar 3, 2019
Completion
Mar 3, 2019
Last update
Oct 3, 2019

Study contacts

Bruno Greff, MD
principal investigator · Sainte Justine's Hospital
Ossam Rhondali, MD
study director · Sainte Justine's Hospital
Jose Luis Martinez, MD
study chair · Sainte Justine's Hospital
Chantal Crochetière, MD
study chair · Sainte Justine's Hospital
Valérie Gaspard, MD
study chair · Sainte Justine's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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