NCT03281473

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 2, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

July 11, 2017

Last Update Submit

March 19, 2019

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDSEsophageal pressureMechanical ventilation

Outcome Measures

Primary Outcomes (1)

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

    2 hours 15 minutes

Secondary Outcomes (2)

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

    2 hours 15 min

  • Short-term effects of 2 PEEP titration strategies on hemodynamics

    2 hours 15 min

Study Arms (2)

Arms A

EXPERIMENTAL

Strategy 1 - Washout period - Strategy 2

Other: Strategy 1Other: Strategy 2

Arms B

EXPERIMENTAL

Strategy 2 - Washout period - Strategy 1

Other: Strategy 1Other: Strategy 2

Interventions

Strategy 1OTHER

PEEP titration according to transpulmonary-end-expiratory pressure

Arms AArms B
Strategy 2OTHER

PEEP titration according to chest wall elastance measurement

Arms AArms B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, France

RECRUITING

Related Publications (1)

  • Chean D, Courtais A, Pavlovsky B, Yvin E, Desprez C, Taillantou-Candau M, Piquilloud L, Richard JC, Mercat A, Beloncle FM. Comparison of two transpulmonary pressure-based positive end-expiratory pressure titration strategies in acute respiratory distress syndrome: a randomized crossover study. Crit Care. 2025 Sep 29;29(1):409. doi: 10.1186/s13054-025-05626-x.

    PMID: 41024114DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Study Official is required by the WHO and BELONCLE, Ass.Pr

    Angers teatching hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Official is required by the WHO and BELONCLE, Ass.Pr

CONTACT

0241353845Francois.Beloncle@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2017

First Posted

September 13, 2017

Study Start

October 2, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)