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

NCT04889807 | Completed

• 1 other identifier: PO21031*
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Preload Responsiveness; Fluid Responsiveness

Outcome Measures

Primary Outcomes (1)

• 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.

  15 seconds

Study Arms (1)

Patients who need fluid perfusion

Other: measure of EtCO2 variation

Interventions

measure of EtCO2 variation OTHER

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

Patients who need fluid perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• younger than 18 years old
• pregnant patients

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: May 5, 2021
• Primary Completion: July 30, 2021
• Study Completion: August 1, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

FR (1)