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OpenTrials
Completed

NCT Number: NCT03567031

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

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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Key information

Conditions

Anesthesia, General Infant

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sainte Justine's Hospital

Montreal, Quebec, H3T 1C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EtCO2 modification

Procedure

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

Primary outcomes

  1. NIRS variation

    Time frame: 5 to 10 minutes

    Near-Infrared Spectroscopy value variation after EtCO2 modification

Secondary outcomes

  1. DTC variation

    Time frame: 5 to 10 minutes

    Transcranial Doppler values variation after EtCO2 modification

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2018
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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