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
| Type | Name | Description |
|---|---|---|
| OTHER | Normocapnia | Normoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa) |
| OTHER | Mild Hypercapnia | Decrease 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.