Positive End-expiratory Pressure Effects to Predict Fluid Responsiveness

NCT04023786 | Completed

• 1 other identifier: 2018-A01599-46
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mechanical Ventilation

Keywords

PEEP test preload dependancy fluid responsiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Relationship between the ability of the PEEP test to detect a preload-dependancy and secondly the PEEP delta induced by the test

  At the end of the hospitalization in intensive care unit (1 month maximum)

• 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)

Study Arms (1)

70 patients, one arm

EXPERIMENTAL

All patients benefits of a passive leg raising test and a PEEP test to compare these two tests.

Procedure: PEEP-TEST; Device: The VenArt System

Interventions

PEEP-TEST PROCEDURE

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.

70 patients, one arm

The VenArt System DEVICE

The VenArt System for estimating cardiac output (a patch stuck to the surface of the neck and a saturation sensor placed at the tip of a finger).

70 patients, one arm

Eligibility Criteria

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

You may qualify if:

• 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).
• Ikorus urinary catheter in place
• Decision by the doctors in charge of carrying out a passive leg raising test and / or a volume expansion

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Dr Alexandra Beurton

Le Kremlin-Bicêtre, Val de Marne, France

Location

Dr Alexandra Beurton

Paris, 75651, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 18, 2019
• Study Start: December 13, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)