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Trial record 11 of 577 for:    CARBON DIOXIDE AND anesthesia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 23, 2018
First Posted Date  ICMJE June 25, 2018
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE November 27, 2017
Actual Primary Completion Date March 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
NIRS variation [ Time Frame: 5 to 10 minutes ]
Near-Infrared Spectroscopy value variation after EtCO2 modification
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03567031 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
DTC variation [ Time Frame: 5 to 10 minutes ]
Transcranial Doppler values variation after EtCO2 modification
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Anesthesia, General
  • Infant
Intervention  ICMJE Procedure: EtCO2 modification
Controlled modification of EtCO2 through modification of ventilation parameters under general anesthesia without spontaneous breathing
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 3, 2019
Actual Primary Completion Date March 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03567031
Other Study ID Numbers  ICMJE #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  ICMJE
Plan to Share IPD: No
Responsible Party Bruno Greff, St. Justine's Hospital
Study Sponsor  ICMJE St. Justine's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP