Clinical trial NCT02429154: Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants (VARO)
Official title: Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercapnia
Keywords: spectroscopy, near-infrared
Infant
Anesthesia, general
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Assessment of the changes in TOI and THI as measured by NIRS under normocapnia and permissive hypercapnia
timeFrame: 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:
measure: Blood gas analysis
timeFrame: 5 or 20 minutes after reaching the steady state with ETCO2
measure: Blood Pressure
timeFrame: At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level
measure: Heart rate
timeFrame: At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level
measure: Body temperature
timeFrame: At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva Children's Hospital
Study officials:
affiliation: University of Geneva
name: Walid Habre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schopfer L, Habre W, Pichon I, Fodor GH. Effect of Permissive Mild Hypercapnia on Cerebral Vasoreactivity in Infants: A Randomized Controlled Crossover Trial. Anesth Analg. 2021 Oct 1;133(4):976-983. doi: 10.1213/ANE.0000000000005325.