PtCO2, Extracorporeal VentilationNCT02362841
Assessment of the Evolutions of Transcutaneous CO2 With the Modification of Blood Flow During On-pump Cardiac Surgery
An observational study of PtCO2, Extracorporeal Ventilation, run by European Georges Pompidou Hospital.
Trial summary
There are no available criteria for determining the optimal flow rate and mean arterial pressure level in patients under cardiopulmonary bypass (CPB). Transcutaneous carbon dioxide tension (PtCO2) has been proposed for microcirculation monitoring and it could be useful for guiding hemodynamic optimization under CPB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PtCO2, Extracorporeal Ventilation
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Sep 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for cardiac surgery under cardiac arrest and cardiopulmonary bypass were prospectively included in the present observational study conducted at a French teaching hospital.
Who may be able to join
- Patients scheduled for cardiac surgery under cardiac arrest and cardiopulmonary bypass were prospectively included in the present observational study conducted at a French teaching hospital.
Who cannot join
- The exclusion criteria were: age <18, pregnancy, septic or emergency surgery.
About this study
There are no available criteria for determining the optimal flow rate and mean arterial pressure level in patients under cardiopulmonary bypass (CPB). Transcutaneous carbon dioxide tension (PtCO2) has been proposed for microcirculation monitoring and it could be useful for guiding hemodynamic optimization under CPB. The goal of this exploratory study was to determine the factors that influence PtCO2 variations during CPB.
DESIGN: Cutaneous ear lobe CO2 tension was monitored along with hemodynamic parameters every 10 minutes during CPB, until aortic unclamping. SETTING: French university teaching hospital PARTICIPANTS: Patients scheduled for cardiac surgery requiring CPB were prospectively included.
- Conditions
- PtCO2, Extracorporeal Ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
PtCO2
Measured: intraoperative value
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startJan 2012
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PtCO2, Extracorporeal VentilationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pirracchio Romain, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362841
- Sponsor's protocol ID
- HEGP-SAR-001
- Status last verified
- Feb 2015
- First submitted
- 9 Feb 2015
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Evolutions of Transcutaneous CO2 With the Modification of Blood Flow During On-pump Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02362841
- Acronym / sponsor ID
- HEGP-SAR-001
- Conditions
- PtCO2, Extracorporeal Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- First posted
- 13 Feb 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.
There are no available criteria for determining the optimal flow rate and mean arterial pressure level in patients under cardiopulmonary bypass (CPB). Transcutaneous carbon dioxide tension (PtCO2) has been proposed for microcirculation monitoring and it could be useful for guiding hemodynamic optimization under CPB. The goal of this exploratory study was to determine the factors that influence PtCO2 variations during CPB.
DESIGN: Cutaneous ear lobe CO2 tension was monitored along with hemodynamic parameters every 10 minutes during CPB, until aortic unclamping. SETTING: French university teaching hospital PARTICIPANTS: Patients scheduled for cardiac surgery requiring CPB were prospectively included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for cardiac surgery under cardiac arrest and cardiopulmonary bypass were prospectively included in the present observational study conducted at a French teaching hospital.
Key inclusion criteria (1 listed)
- Patients scheduled for cardiac surgery under cardiac arrest and cardiopulmonary bypass were prospectively included in the present observational study conducted at a French teaching hospital.
Key exclusion criteria (1 listed)
- The exclusion criteria were: age <18, pregnancy, septic or emergency surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PtCO2
Time frame: intraoperative value
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 13 Feb 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of PtCO2, Extracorporeal Ventilation, run by European Georges Pompidou Hospital.
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 1 inclusion and 1 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 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
PtCO2 (time frame: intraoperative value). 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 13 Feb 2015; AzTrials last refreshed its copy on 7 Nov 2026.