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Clinical Trials/NCT02429154
NCT02429154
Completed
Not Applicable

Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants

Walid HABRE1 site in 1 country20 target enrollmentSeptember 2015
ConditionsHypercapnia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypercapnia
Sponsor
Walid HABRE
Enrollment
20
Locations
1
Primary Endpoint
Assessment of the changes in TOI and THI as measured by NIRS under normocapnia and permissive hypercapnia
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to show that a permissive hypercapnia during mechanical ventilation in children under general anaesthesia will improve cerebral perfusion.

Detailed Description

Mechanical ventilation interferes with cerebral perfusion via the changes in intrathoracic pressure and/or as a consequence of hypocapnia. This latter occurs frequently following traditional ventilation strategies with relatively high tidal volume and respiratory rate. New trends in anesthesia intend to promote protective lung ventilation by keeping a normocapnic or even mildly hypercapnic state. However, cerebral vascular vasotonicity is carbon dioxide (CO2)-dependent with hypocapnia potentially leading to vasoconstriction and subsequent decrease in cerebral blood flow. Changes in cerebral vasoreactivity can be assessed by the near infrared spectroscopy (NIRS) device. This monitoring evaluates the changes in various parameters (deoxygenated hemoglobin, oxygenated hemoglobin, the tissue oxygenation index (TOI) and the tissue hemoglobin index (THI)) that act as surrogate for cerebral vasoconstriction. We, therefore designed this prospective observational comparative effectiveness study in order to characterize the potential beneficial effect of permissive hypercapnia on cerebral perfusion in infants.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
September 30, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Walid HABRE
Responsible Party
Sponsor Investigator
Principal Investigator

Walid HABRE

Associated Professor

University Hospital, Geneva

Eligibility Criteria

Inclusion Criteria

  • term neonates during their infancy
  • for elective surgery requiring general anesthesia and endotracheal intubation

Exclusion Criteria

  • all infants with cardiac anomalies, chronic pulmonary disease (bronchopulmonary dysplasia, cystic fibrosis, asthma), pulmonary hypertension or cranial hypertension will be excluded
  • all infants where no access to the forehead is possible as a consequence of the operating field

Outcomes

Primary Outcomes

Assessment of the changes in TOI and THI as measured by NIRS under normocapnia and permissive hypercapnia

Time Frame: At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level

Secondary Outcomes

  • Body temperature(At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level)
  • Blood Pressure(At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level)
  • Blood gas analysis(5 or 20 minutes after reaching the steady state with ETCO2)
  • Heart rate(At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level)

Study Sites (1)

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