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

January 3, 2018 updated by: Walid HABRE

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

The purpose of this study is to show that a permissive hypercapnia during mechanical ventilation in children under general anaesthesia will improve cerebral perfusion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1206
        • Geneva Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Normocapnia
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.
Other: Normocapnia
Normoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa)
Other: Mild Hypercapnia
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
Other: Mild Hypercapnia
Decrease in minute ventilation in order to increase ETCO2 to 6.5 kPa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood gas analysis
Time Frame: 5 or 20 minutes after reaching the steady state with ETCO2
Assessment changes in oxygen partial pressure (PaO2), carbon dioxide partial pressure (PaCO2) and potential of hydrogen (pH) under one level of ETCO2
5 or 20 minutes after reaching the steady state with ETCO2
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
Non invasive monitoring of blood pressure
At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level
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
Non invasive recording of heart rate
At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level
Body temperature
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
Naso-pharyngeal temperature probe
At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Walid HABRE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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