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

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567031
• Other study ID #: #2017-1309
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia, General
• Infant

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