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Completed

NCT Number: NCT04023786

Positive End-expiratory Pressure Effects to Predict Fluid Responsiveness

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Alexandra Beurton, Le Kremlin-Bicêtre, Val de Marne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).
  • Ikorus urinary catheter in place
  • 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).

Treatment and study plan

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.

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).

Primary outcomes

  1. Ability of the PEP test to detect a preload-dependency condition.

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

    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.

Secondary outcomes

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

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

    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).

  2. Ability of the PEP test to detect a response to volume expansion.

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

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PEEP-TEST

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 18, 2019
Registry last updated
Feb 11, 2026

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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