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Clinical Trials/NCT03567031
NCT03567031CompletedNot Applicable

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

St. Justine's Hospital2 sites in 1 country60 target enrollmentStarted: November 27, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
NIRS variation

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Masking Description

Patient is under general anesthesia

Eligibility Criteria

Ages
— to 6 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Main Arm

Experimental

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: EtCO2 modification (Procedure)

Outcomes

Primary Outcomes

NIRS variation

Time Frame: 5 to 10 minutes

Near-Infrared Spectroscopy value variation after EtCO2 modification

Secondary Outcomes

  • DTC variation(5 to 10 minutes)

Investigators

Sponsor
St. Justine's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bruno Greff

Principal Investigator

St. Justine's Hospital

Study Sites (2)

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