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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Strategy 1
Strategy 2
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, Esophageal pressure, Mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arms A

Arms B

Arm Description

Strategy 1 - Washout period - Strategy 2

Strategy 2 - Washout period - Strategy 1

Outcomes

Primary Outcome Measures

Short-term effects of 2 PEEP titration strategies on gas exchange

Secondary Outcome Measures

Short-term effects of 2 PEEP titration strategies on respiratory mechanics
Short-term effects of 2 PEEP titration strategies on hemodynamics

Full Information

First Posted
July 11, 2017
Last Updated
March 19, 2019
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT03281473
Brief Title
Comparison of Positive End Expiratory Pressure Titration Methods in ARDS Patients
Acronym
ELSE
Official Title
Comparison of Positive End Expiratory Pressure Titration Methods in Patients With Acute Respiratory Distress Syndrome: a Physiological Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
ARDS, Esophageal pressure, Mechanical ventilation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arms A
Arm Type
Experimental
Arm Description
Strategy 1 - Washout period - Strategy 2
Arm Title
Arms B
Arm Type
Experimental
Arm Description
Strategy 2 - Washout period - Strategy 1
Intervention Type
Other
Intervention Name(s)
Strategy 1
Intervention Description
PEEP titration according to transpulmonary-end-expiratory pressure
Intervention Type
Other
Intervention Name(s)
Strategy 2
Intervention Description
PEEP titration according to chest wall elastance measurement
Primary Outcome Measure Information:
Title
Short-term effects of 2 PEEP titration strategies on gas exchange
Time Frame
2 hours 15 minutes
Secondary Outcome Measure Information:
Title
Short-term effects of 2 PEEP titration strategies on respiratory mechanics
Time Frame
2 hours 15 min
Title
Short-term effects of 2 PEEP titration strategies on hemodynamics
Time Frame
2 hours 15 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Official is required by the WHO and BELONCLE, Ass.Pr
Phone
0241353845
Email
Francois.Beloncle@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Official is required by the WHO and BELONCLE, Ass.Pr
Organizational Affiliation
Angers teatching hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François BELONCLE, Ass.Pr
Phone
0241353845
Email
Francois.Beloncle@chu-angers.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Positive End Expiratory Pressure Titration Methods in ARDS Patients

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