Assessment of Preload Dependency Via Measurement of Peripheral Venous Pressure During an Alveolar Recruitment Manoeuvre (PVP-StepPEP)

June 28, 2024 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche

Assessment of preload dependency via measurement of peripheral venous pressure during an alveolar recruitment manoeuvre.

Prospective multicentre open-label study of mechanically ventilated intensive care patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France, 42100
        • Hôpital Privé de la Loire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 years or older, for whom the trusted person designated by the patient or, failing that, a relative has read and signed the consent form for participation in the study
  • Patient hospitalised in intensive care, under sedation and controlled mechanical ventilation
  • Equipped with a central venous line in the superior vena cava territory and an arterial catheter.
  • Whose state of health justifies vascular filling

Exclusion Criteria:

  • Patient under legal protection, guardianship or curatorship
  • Pregnant or breastfeeding woman
  • Patient not affiliated to the French social security system
  • Contraindication to the realization of an alveolar recruitment maneuver

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mechanically ventilated intensive care patients.
Observational data collected for patients in intensive care under mechanical ventilation.
Procedure: alveolar recruitment manoeuvre by pressure step
The application of alveolar recruitment manoeuvres consists of transiently increasing alveolar pressure in order to re-open collapsed alveolar territories and to re-ventilate poorly ventilated or non-ventilated lung areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome measure
Time Frame: through study completion, an average of 12 hours
The correlation between the pairs of values of CVP and PVP during an alveolar recruitment manoeuvre will be evaluated by Pearson's coefficient or Spearman's coefficient if the distribution of the values is not parametric. The coefficient of determination r² will be calculated by linear regression between the 2 variables. Finally, the agreement between the two measurements will be evaluated by the Bland-Altman method: the Bland-Altman graph will be provided and the 95% agreement limits will be calculated (+/- 1.96 SD, SD being the standard deviation of the difference between the measurements).
through study completion, an average of 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcome measure
Time Frame: through study completion, an average of 12 hours
Predictive value of the evolution of PVP during the recruitment manoeuvre: the ROC curve (receiver-operating characteristic) will be performed by logistic regression. The area under the ROC curve will be given as well as the sensitivity, specificity and negative and positive predictive values (Younden index will be used to determine the optimal threshold of PVP).
through study completion, an average of 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2021

Primary Completion (Actual)

August 29, 2022

Study Completion (Actual)

August 29, 2022

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-A02683-36

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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