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 (CapnoPause)

March 21, 2022 updated by: CHU de Reims

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

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

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 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.
Observational

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.
41

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

  • France
      • Reims, France, 51092
        • Chu Reims

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • younger than 18 years old
  • pregnant patients

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Patients who need fluid perfusion
Other: measure of EtCO2 variation
measure of EtCO2 (end tidal carbon dioxide) variation after an 15 seconds end-expiratory occlusion test

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
Measure Description
Time Frame
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.
15 seconds

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.
CHU de Reims

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 (Actual)

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.
May 5, 2021

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.
July 30, 2021

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.
August 1, 2021

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).
May 12, 2021

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.
May 12, 2021

First Posted (Actual)

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.
May 17, 2021

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.
March 22, 2022

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.
March 21, 2022

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.
March 1, 2022

More Information

Terms related to this study

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.
  • PO21031*

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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