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Completed

NCT Number: NCT04889807

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Reims

Reims, 51092, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

measure of EtCO2 variation

Other

measure of EtCO2 (end tidal carbon dioxide) variation after an 15 seconds end-expiratory occlusion test

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: CapnoPause

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 17, 2021
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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