Positive End-expiratory Pressure Effects to Predict Fluid Responsiveness

Mechanical Ventilation Clinical Trial

— PEEP-TEST  

Official title:

Positive End-expiratory Pressure Effects to Predict Fluid Responsiveness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04023786
• Other study ID #: 2018-A01599-46
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: July 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Volume expansion is one of the main treatments for shock. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary.PEEP test would be an easy alternative to the tests used in current practice.

Description:

Volume expansion is one of the main treatments for shock, with the goal of increasing cardiac preload and, consequently, cardiac output. However, this increase only occurs if there is a preload-dependence of cardiac output, which is present in 50% of cases. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary. The end-expiratory pressure test (PEEP) would be to vary the PEEP in patients in shock conditions placed under mechanical ventilation. PEEP is the positive pressure maintained in the airways at the end of expiration. It opposes systemic venous return and lowers cardiac preload. It also distends the pulmonary vessels, increases their resistance and opposes the ejection of the right ventricle. The decrease in PEEP could alleviate the obstacle to venous return and thus increase cardiac preload, mimicking a volume expansion, increasing cardiac output only in the case of preload dependence. This test would be an easy alternative to the tests used in current practice. To evaluate the ability of the PEEP test to detect a preload-dependence condition, defined by a passive passive leg raising test, in patients in shock.

The primary endpoint will be the area under the receiver operating characteristic (ROC) curve constructed to describe the ability of the PEEP test to detect a preload-dependency condition. We measure cardiac output by analysis of the pulse wave contour before and after the passive leg raising and PEEP test tests, then according to these tests, measurement of the cardiac output before and after volume expansion.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Coverage by a health insurance scheme

• Patient under mechanical invasive ventilation (tracheal intubation)

• PEEP level =10 cmH2O

• Cardiac flow monitoring device in place by the PiCCO2 system (Pulsion Medical Systems, Feldkirch, Germany).

• Decision by the doctors in charge of carrying out a passive leg raising test and / or a volume expansion

Exclusion Criteria:

• Pregnancy

• Participation in another interventional study

• Patients under the protection of justice

• Thoracic drainage (preventing PEP changes from inducing intrathoracic and transpulmonary pressure changes from their hemodynamic effects).

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Procedure:
• PEEP-TEST
The PEEP test will consist of lowering the PEEP level to 5 cmH2O for a maximum of 2 minutes and a minimum of 1 minute. Patients will be included if the physicians who care for them have decided to set a baseline PEEP level =10 cmH2O.

Locations

Country	Name	City	State
France	Dr Alexandra Beurton	Le Kremlin-Bicêtre	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of the PEP test to detect a preload-dependency condition.	The primary endpoint will be the area under the receiver operating characteristic (ROC) curve constructed to describe the ability of the PEP test to detect a preload-dependency condition.	At the end of the hospitalization in intensive care unit (1 month maximum)
Secondary	Relationship between the ability of the PEEP test to detect a preload-dependancy and secondly the PEEP delta induced by the test	The secondary endpoint will be the relationship between the area under the curve constructed to describe the ability of the PEP test to detect a preload-dependency state and the PEP delta induced by the test (PEP starting, high, PEP during the test, at 5 cmH2O).	At the end of the hospitalization in intensive care unit (1 month maximum)
Secondary	Ability of the PEP test to detect a response to volume expansion.	The secondary endpoint will be the area under the curve constructed to describe the ability of the PEP test to detect a response to volume expansion.	At the end of the hospitalization in intensive care unit (1 month maximum)