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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03567031
Other study ID # #2017-1309
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 27, 2017
Est. completion date March 3, 2019

Study information

Verified date October 2019
Source St. Justine's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 3, 2019
Est. primary completion date March 3, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 6 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Sainte Justine's Hospital Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary NIRS variation Near-Infrared Spectroscopy value variation after EtCO2 modification 5 to 10 minutes
Secondary DTC variation Transcranial Doppler values variation after EtCO2 modification 5 to 10 minutes
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