HypercapniaVARONCT02429154
Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants (VARO)
A study testing Normocapnia and Mild Hypercapnia in people with Hypercapnia, run by Walid HABRE at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Hypercapnia
- What is being tested?
- Normocapnia and Mild Hypercapnia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2015to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- term neonates during their infancy
- for elective surgery requiring general anesthesia and endotracheal intubation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Hypercapnia
- Being tested
- Normocapnia, Mild Hypercapnia
- Keywords
- spectroscopy, near-infrared, Infant, Anesthesia, general
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NormocapniaOther
Normoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa)
Mild HypercapniaOther
Decrease in minute ventilation in order to increase ETCO2 to 6.5 kPa
| Study group | Role | What they receive |
|---|---|---|
| Normocapnia | Active comparator | 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. Receives: Other: Normocapnia |
| Mild Hypercapnia | Other | 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 Receives: Other: Mild Hypercapnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the changes in TOI and THI as measured by NIRS under normocapnia and permissive hypercapnia
Measured: 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 (4)
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
Measured: 5 or 20 minutes after reaching the steady state with ETCO2
Blood Pressure
Non invasive monitoring of blood pressure
Measured: 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
Non invasive recording of heart rate
Measured: 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
Naso-pharyngeal temperature probe
Measured: At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercapniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walid HABRE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walid HABRE, University Hospital, Geneva
- Investigators
- Walid Habre, MD, PhD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429154
- Sponsor's protocol ID
- 14-204
- Acronym
- VARO
- Status last verified
- Jan 2018
- First submitted
- 11 Mar 2015
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33410612
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants
- ClinicalTrials.gov ID
- NCT02429154
- Acronym / sponsor ID
- VARO / 14-204
- Conditions
- Hypercapnia
- Keywords
- spectroscopy, near-infrared, Infant, Anesthesia, general
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Walid HABREUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normocapnia | Active comparator | Other: NormocapniaThe 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. |
| Mild Hypercapnia | Other | Other: Mild HypercapniaThe 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 |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- term neonates during their infancy
- for elective surgery requiring general anesthesia and endotracheal intubation
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NormocapniaNormoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa) | Other | Normocapnia |
| Mild HypercapniaDecrease in minute ventilation in order to increase ETCO2 to 6.5 kPa | Other | Mild Hypercapnia |
Primary outcome
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
4 secondary outcomes
Blood gas analysis
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Derived from this study: PubMed 33410612Schopfer 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.
Related trials for Hypercapnia
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Not yet recruiting
Comparing Two Types of Breathing Support in People With COPD, High Carbon Dioxide Levels, and Sleep Apnea
OSA COPD Overlap Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walid Habre, MD, PhD principal investigator
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normocapnia and Mild Hypercapnia in people with Hypercapnia, run by Walid HABRE at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.