Preload ResponsivenessCapnoPauseNCT04889807
Study of End Tidal Carbon Dioxide (EtCO2) Variation After an End- Expiratory Occlusion Test as a Predictive Criteria of Fluid Responsiveness in Mechanically Ventilated Patients
An observational study of Preload Responsiveness and Fluid Responsiveness, run by CHU de Reims at 1 site in France.
Trial summary
Hypovolemia is one of major factor of haemodynamic instability. Fluid administration is not totally riskless. Indeed, it can create or inflate pulmonary oedema, alter gaz exchanges and increase post operative respiratory complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preload Responsiveness, Fluid Responsiveness
- What is being tested?
- measure of EtCO2 variation
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2021to 1 Aug 2021
- 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 in intensive care unit, under mechanical ventilation and eligible to a fluid administration, who are capable to hold a 15 seconds end expiratory occlusion test.
Who may be able to join
- older than 18 years old
- critically ill patients
- under mechanical ventilation
- whose cardiac output is measurable by transthoracic echography, or monitored by a transpulmonary thermodilution catheter or pulmonary arterial catheter
- eligible to a fluid perfusion, by the physician in charge appreciation
Who cannot join
- younger than 18 years old
- pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Hypovolemia is one of major factor of haemodynamic instability. Fluid administration is not totally riskless. Indeed, it can create or inflate pulmonary oedema, alter gaz exchanges and increase post operative respiratory complications. Furthermore, fluid administration is not always followed by a cardiac output increase.
Predicting preload responsiveness before administering fluid by reliable and reproductible methods is necessary in critically ill patients.
Read more
Dynamic indicators are approved at the bedside such as passive raising leg test, pulse pressure variation, respiratory variation of the diameter of the superior vena cava. However, all these tests cannot be used for all patients. For example in the cases of spine or pelvis injury, or traumatic brain injury, patients with difficult condition for transthoracic echography.
The investigators hypothesize that EtCO2 (end tidal carbon dioxide) variation after an 15 seconds end-expiratory occlusion test could predict fluid responsiveness in mechanically ventilated patients in the intensive care units.
EtCO2 is a parameter which can be easy to collect, reproductible, and totally non invasive. This method could be especially appropriate for patients for whom the classical test of fluid responsiveness cannot be used
Read the detailed description
For each patient under mechanical ventilation, answering inclusions and non inclusions criteria, and eligible to a fluid perfusion, the physician in charge collect vital parameters such as cardiac frequency, blood pressure, cardiac output and end tidal carbon dioxide.
The cardiac output is measured by transthoracic echography, or invasive devices such as transpulmonary thermodilution or pulmonary arterial catheter.
The physician achieve a 15 seconds interruption of mechanical ventilation at end expiration, and collect the end tidal carbon dioxide variation.
Fluid perfusion of 500 ml of crystalloid is performed. Then the physician collect the same vital parameters, including a new cardiac output measure.
The patients for whom the cardiac output increased about more than 15 percent are considered as responders, the others are considered as non responders.
Furthermore, socio demographic parameter, reason for admission, parameters of mechanical ventilation, use of vasopressor drugs and water balance are collected.
- Conditions
- Preload Responsiveness, Fluid Responsiveness
- Being tested
- measure of EtCO2 variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure of EtCO2 variationOther
measure of EtCO2 (end tidal carbon dioxide) variation after an 15 seconds end-expiratory occlusion test
| Study group | Role | What they receive |
|---|---|---|
| Patients who need fluid perfusion | Not described Receives: Other: measure of EtCO2 variation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive capacity of the variation of end tidal carbon dioxide after an end expiratory occlusion test
A receiver operating characteristic (ROC) curve analysis will be performed to determine the sensitivity, the specificity, the positive and negative predictive values.
Measured: 15 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start5 May 2021
- Primary completion30 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preload ResponsivenessStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889807
- Sponsor's protocol ID
- PO21031*
- Acronym
- CapnoPause
- Status last verified
- Mar 2022
- First submitted
- 12 May 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of End Tidal Carbon Dioxide (EtCO2) Variation After an End- Expiratory Occlusion Test as a Predictive Criteria of Fluid Responsiveness in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT04889807
- Acronym / sponsor ID
- CapnoPause / PO21031*
- Conditions
- Preload Responsiveness, Fluid Responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 17 May 2021 (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.
Hypovolemia is one of major factor of haemodynamic instability. Fluid administration is not totally riskless. Indeed, it can create or inflate pulmonary oedema, alter gaz exchanges and increase post operative respiratory complications. Furthermore, fluid administration is not always followed by a cardiac output increase.
Predicting preload responsiveness before administering fluid by reliable and reproductible methods is necessary in critically ill patients.
Dynamic indicators are approved at the bedside such as passive raising leg test, pulse pressure variation, respiratory variation of the diameter of the superior vena cava. However, all these tests cannot be used for all patients. For example in the cases of spine or pelvis injury, or traumatic brain injury, patients with difficult condition for transthoracic echography.
The investigators hypothesize that EtCO2 (end tidal carbon dioxide) variation after an 15 seconds end-expiratory occlusion test could predict fluid responsiveness in mechanically ventilated patients in the intensive care units.
EtCO2 is a parameter which can be easy to collect, reproductible, and totally non invasive. This method could be especially appropriate for patients for whom the classical test of fluid responsiveness cannot be used
Detailed description
For each patient under mechanical ventilation, answering inclusions and non inclusions criteria, and eligible to a fluid perfusion, the physician in charge collect vital parameters such as cardiac frequency, blood pressure, cardiac output and end tidal carbon dioxide.
The cardiac output is measured by transthoracic echography, or invasive devices such as transpulmonary thermodilution or pulmonary arterial catheter.
The physician achieve a 15 seconds interruption of mechanical ventilation at end expiration, and collect the end tidal carbon dioxide variation.
Fluid perfusion of 500 ml of crystalloid is performed. Then the physician collect the same vital parameters, including a new cardiac output measure.
The patients for whom the cardiac output increased about more than 15 percent are considered as responders, the others are considered as non responders.
Furthermore, socio demographic parameter, reason for admission, parameters of mechanical ventilation, use of vasopressor drugs and water balance are collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who need fluid perfusion | – | Other: measure of EtCO2 variation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in intensive care unit, under mechanical ventilation and eligible to a fluid administration, who are capable to hold a 15 seconds end expiratory occlusion test.
Key inclusion criteria (5 listed)
- older than 18 years old
- critically ill patients
- under mechanical ventilation
- whose cardiac output is measurable by transthoracic echography, or monitored by a transpulmonary thermodilution catheter or pulmonary arterial catheter
- eligible to a fluid perfusion, by the physician in charge appreciation
Key exclusion criteria (2 listed)
- younger than 18 years old
- pregnant patients
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 |
|---|---|---|
| measure of EtCO2 variationmeasure of EtCO2 (end tidal carbon dioxide) variation after an 15 seconds end-expiratory occlusion test | Other | Patients who need fluid perfusion |
Primary outcome
Predictive capacity of the variation of end tidal carbon dioxide after an end expiratory occlusion test
Time frame: 15 seconds
A receiver operating characteristic (ROC) curve analysis will be performed to determine the sensitivity, the specificity, the positive and negative predictive values.
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 22 Mar 2022.
Related trials for Preload Responsiveness
Enrolling by invitationObservational study
Changes in Pulse-Oximetry Perfusion Index Induced by Tidal Volume Challenge Versus Fluid Volume Challenge to Detect Preload Responsiveness in Mechanically Ventilated Patients With Low Tidal Volume
To Assess the Ability of PI to Detect Preload Responsiveness
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preload Responsiveness and Fluid Responsiveness, run by CHU de Reims at 1 site in France.
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 5 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 22 Mar 2022. 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 France. 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?
Predictive capacity of the variation of end tidal carbon dioxide after an end expiratory occlusion test (time frame: 15 seconds). 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 22 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.