Clinical Trials Directory

Trials / Completed

CompletedNCT02429154

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Walid HABRE · Academic / Other
Sex
All
Age
1 Day – 1 Year
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNormocapniaNormoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa)
OTHERMild HypercapniaDecrease in minute ventilation in order to increase ETCO2 to 6.5 kPa

Timeline

Start date
2015-09-01
Primary completion
2017-09-01
Completion
2017-09-30
First posted
2015-04-29
Last updated
2018-01-04

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT02429154. Inclusion in this directory is not an endorsement.