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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2019-03-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia, General Infant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cerebral blood flow is measured in each patient at 3 different, controlled levels of end-tidal CO2

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Patient is under general anesthesia

Study Groups

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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.

Group Type EXPERIMENTAL

EtCO2 modification

Intervention Type PROCEDURE

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

Interventions

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EtCO2 modification

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes