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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02429154
Acronym
VARO
Enrollment
20
Registered
2015-04-29
Start date
2015-09-30
Completion date
2017-09-30
Last updated
2018-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercapnia

Keywords

spectroscopy, near-infrared, Infant, Anesthesia, general

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.

Interventions

Normoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa)

Decrease in minute ventilation in order to increase ETCO2 to 6.5 kPa

Sponsors

Walid HABRE
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Assessment of the changes in TOI and THI as measured by NIRS under normocapnia and permissive hypercapniaAt steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level

Secondary

MeasureTime frameDescription
Blood gas analysis5 or 20 minutes after reaching the steady state with ETCO2Assessment changes in oxygen partial pressure (PaO2), carbon dioxide partial pressure (PaCO2) and potential of hydrogen (pH) under one level of ETCO2
Blood PressureAt steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each levelNon invasive monitoring of blood pressure
Heart rateAt steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each levelNon invasive recording of heart rate
Body temperatureAt steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each levelNaso-pharyngeal temperature probe

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026