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

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

Tracking Information

• First Submitted Date: May 23, 2018
• First Posted Date: June 25, 2018
• Last Update Posted Date: October 3, 2019
• Actual Study Start Date: November 27, 2017
• Actual Primary Completion Date: March 3, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 21, 2018)

NIRS variation [ Time Frame: 5 to 10 minutes ]

Near-Infrared Spectroscopy value variation after EtCO2 modification

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03567031 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: June 21, 2018)

DTC variation [ Time Frame: 5 to 10 minutes ]

Transcranial Doppler values variation after EtCO2 modification

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia
• Official Title: Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia
• 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.
• 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
• Study Phase: Not Applicable

Study Design

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

Condition

• Anesthesia, General
• Infant

Intervention

Procedure: EtCO2 modification

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

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.

Intervention: Procedure: EtCO2 modification

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 21, 2018): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 3, 2019
• Actual Primary Completion Date: March 3, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 6 Months (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03567031
• Other Study ID Numbers: #2017-1309
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Bruno Greff, St. Justine's Hospital
• Study Sponsor: St. Justine's Hospital
• Collaborators: Not Provided

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

• PRS Account: St. Justine's Hospital
• Verification Date: October 2019