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

Primary Purpose

Hypercapnia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Normocapnia
Mild Hypercapnia
Sponsored by
Walid HABRE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypercapnia focused on measuring spectroscopy, near-infrared, Infant, Anesthesia, general

Eligibility Criteria

1 Day - 1 Year (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geneva Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Normocapnia

Mild Hypercapnia

Arm Description

The Child will be ventilated in order to achieve an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa). Measurements will be performed after steady state condition. Then the ventilation will be reduced to allow ETCO2 to reach 6.5 kPa before repeating the measurements. Finally, the child will be again ventilated to obtain a normocapnia condition.

The Child will be ventilated in order to achieve a ETCO2 of 6.5 kPa. Measurements will be performed after steady state condition. Then the ventilation will be increased to allow ETCO2 to reach 5.5 kPa before repeating the measurements. Finally, the child will be again ventilated to obtain a mild hypercapnic condition

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Blood gas analysis
Assessment changes in oxygen partial pressure (PaO2), carbon dioxide partial pressure (PaCO2) and potential of hydrogen (pH) under one level of ETCO2
Blood Pressure
Non invasive monitoring of blood pressure
Heart rate
Non invasive recording of heart rate
Body temperature
Naso-pharyngeal temperature probe

Full Information

First Posted
March 11, 2015
Last Updated
January 3, 2018
Sponsor
Walid HABRE
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1. Study Identification

Unique Protocol Identification Number
NCT02429154
Brief Title
Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants (VARO)
Acronym
VARO
Official Title
Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Walid HABRE

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnia
Keywords
spectroscopy, near-infrared, Infant, Anesthesia, general

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normocapnia
Arm Type
Active Comparator
Arm Description
The Child will be ventilated in order to achieve an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa). Measurements will be performed after steady state condition. Then the ventilation will be reduced to allow ETCO2 to reach 6.5 kPa before repeating the measurements. Finally, the child will be again ventilated to obtain a normocapnia condition.
Arm Title
Mild Hypercapnia
Arm Type
Other
Arm Description
The Child will be ventilated in order to achieve a ETCO2 of 6.5 kPa. Measurements will be performed after steady state condition. Then the ventilation will be increased to allow ETCO2 to reach 5.5 kPa before repeating the measurements. Finally, the child will be again ventilated to obtain a mild hypercapnic condition
Intervention Type
Other
Intervention Name(s)
Normocapnia
Intervention Description
Normoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa)
Intervention Type
Other
Intervention Name(s)
Mild Hypercapnia
Intervention Description
Decrease in minute ventilation in order to increase ETCO2 to 6.5 kPa
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Blood gas analysis
Description
Assessment changes in oxygen partial pressure (PaO2), carbon dioxide partial pressure (PaCO2) and potential of hydrogen (pH) under one level of ETCO2
Time Frame
5 or 20 minutes after reaching the steady state with ETCO2
Title
Blood Pressure
Description
Non invasive monitoring of blood pressure
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
Title
Heart rate
Description
Non invasive recording of heart rate
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
Title
Body temperature
Description
Naso-pharyngeal temperature probe
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walid Habre, MD, PhD
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva Children's Hospital
City
Geneva
ZIP/Postal Code
1206
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33410612
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.
Results Reference
derived

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

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