Comparison of Positive End Expiratory Pressure Titration Methods in ARDS Patients (ELSE)

March 19, 2019 updated by: University Hospital, Angers

Comparison of Positive End Expiratory Pressure Titration Methods in Patients With Acute Respiratory Distress Syndrome: a Physiological Study

This study aims at assessing the short-term physiological effects of 2 positive end expiratory pressure titration strategies in patients with ARDS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

Study Locations

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age> 18 years
  • Moderate or severe ARDS
  • Consent to participation obtained from a relative

Exclusion Criteria:

  • Protect adult
  • Pregnant or breastfeeding woman
  • No-affiliation to the social security scheme
  • Contra-indication to the placement of an esophageal pressure measuring catheter
  • Pneumothorax
  • Hemodynamic and / or respiratory instability
  • Extra-corporeal membrane oxygenation

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arms A
Strategy 1 - Washout period - Strategy 2
Other: Strategy 1
PEEP titration according to transpulmonary-end-expiratory pressure
Other: Strategy 2
PEEP titration according to chest wall elastance measurement
Experimental: Arms B
Strategy 2 - Washout period - Strategy 1
Other: Strategy 1
PEEP titration according to transpulmonary-end-expiratory pressure
Other: Strategy 2
PEEP titration according to chest wall elastance measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short-term effects of 2 PEEP titration strategies on gas exchange
Time Frame: 2 hours 15 minutes
2 hours 15 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Short-term effects of 2 PEEP titration strategies on respiratory mechanics
Time Frame: 2 hours 15 min
2 hours 15 min
Short-term effects of 2 PEEP titration strategies on hemodynamics
Time Frame: 2 hours 15 min
2 hours 15 min

Collaborators and Investigators

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

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Study Official is required by the WHO and BELONCLE, Ass.Pr, Angers teatching hospital

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)

October 2, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC17_0220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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