Anesthesia, GeneralNCT03567031
Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia
A study testing EtCO2 modification in people with Anesthesia, General and Infant, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
The study aims at assessing cerebral blood flow variations following expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, General, Infant
- What is being tested?
- EtCO2 modification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2017to 3 Mar 2019
- 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 Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age < or = 6 months
- ASA class < or = 3
- General anesthesia required for surgery
Who cannot join
- No parental consent
- Emergency surgery
- Preexisting neurological condition
- Hemodynamic instability
- Preexisting hypoxemia and/or hypercapnia
- Laparoscopy or thoracoscopy, if expected EtCO2 level achieving would require unsafe ventilation parameters
Trial locations and contacts
1 site in 1 country.
About this study
The study aims at assessing cerebral blood flow variations following expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia.
Read the detailed description
The study aims at assessing cerebral blood flow (measured with Near-Infrared Reflectance Spectroscopy - NIRS - and transcranial Doppler - DTC) variations following end-tidal expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia performed according to standards of care.
- Conditions
- Anesthesia, General, Infant
- Being tested
- EtCO2 modification
- Keywords
- Pediatric Anesthesia, Near-Infrared Spectroscopy, End-Tidal CO2, Cerebral Blood Flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtCO2 modificationProcedure or surgery
Controlled modification of EtCO2 through modification of ventilation parameters under general anesthesia without spontaneous breathing
| Study group | Role | What they receive |
|---|---|---|
| Main Arm | Experimental | In each patient, under ongoing standard general anesthesia in a stable state, EtCO2 is manually modified to reach predefined values, and after waiting until cerebral blood flow has reached steady state, NIRS and DTC values are noted. Receives: Procedure: EtCO2 modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIRS variation
Near-Infrared Spectroscopy value variation after EtCO2 modification
Measured: 5 to 10 minutes
Secondary outcomes (1)
DTC variation
Transcranial Doppler values variation after EtCO2 modification
Measured: 5 to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start27 Nov 2017
- Primary completion3 Mar 2019
- Study completion3 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cerebral blood flow is measured in each patient at 3 different, controlled levels of end-tidal CO2
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Greff, St. Justine's Hospital
- Investigators
- Bruno Greff, MD, Principal investigator, Sainte Justine's HospitalOssam Rhondali, MD, Study director, Sainte Justine's HospitalJose Luis Martinez, MD, Study chair, Sainte Justine's HospitalChantal Crochetière, MD, Study chair, Sainte Justine's HospitalValérie Gaspard, MD, Study chair, Sainte Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567031
- Sponsor's protocol ID
- #2017-1309
- Status last verified
- Oct 2019
- First submitted
- 23 May 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia
- ClinicalTrials.gov ID
- NCT03567031
- Acronym / sponsor ID
- #2017-1309
- Conditions
- Anesthesia, General, Infant
- Keywords
- Pediatric Anesthesia, Near-Infrared Spectroscopy, End-Tidal CO2, Cerebral Blood Flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 3 Mar 2019 (actual)
- Study completion
- 3 Mar 2019 (actual)
- First posted
- 25 Jun 2018 (actual)
- 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 study aims at assessing cerebral blood flow variations following expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia.
Detailed description
The study aims at assessing cerebral blood flow (measured with Near-Infrared Reflectance Spectroscopy - NIRS - and transcranial Doppler - DTC) variations following end-tidal expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia performed according to standards of care.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cerebral blood flow is measured in each patient at 3 different, controlled levels of end-tidal CO2
| Arm | Type | Receives |
|---|---|---|
| Main Arm | Experimental | Procedure: EtCO2 modificationIn each patient, under ongoing standard general anesthesia in a stable state, EtCO2 is manually modified to reach predefined values, and after waiting until cerebral blood flow has reached steady state, NIRS and DTC values are noted. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age < or = 6 months
- ASA class < or = 3
- General anesthesia required for surgery
Key exclusion criteria (6 listed)
- No parental consent
- Emergency surgery
- Preexisting neurological condition
- Hemodynamic instability
- Preexisting hypoxemia and/or hypercapnia
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 |
|---|---|---|
| EtCO2 modificationControlled modification of EtCO2 through modification of ventilation parameters under general anesthesia without spontaneous breathing | Procedure or surgery | Main Arm |
Primary outcome
NIRS variation
Time frame: 5 to 10 minutes
Near-Infrared Spectroscopy value variation after EtCO2 modification
1 secondary outcome
DTC variation
Time frame: 5 to 10 minutes
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 3 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Bruno Greff, MD principal investigator
Sainte Justine's Hospital
Ossam Rhondali, MD study director
Sainte Justine's Hospital
Jose Luis Martinez, MD study chair
Sainte Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EtCO2 modification in people with Anesthesia, General and Infant, run by St. Justine's Hospital at 1 site in Canada.
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 3 inclusion and 6 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 3 Oct 2019. 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 Canada. 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?
NIRS variation (time frame: 5 to 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2019.