NCT03657524

Brief Summary

Deciding the optimal timing for extubation in patients who are mechanically ventilated can be challenging, and traditional weaning predictor tools are not accurate. Recent studies suggest that isolated sonographic assessment of the respiratory and cardiac function (ie diastolic function and filling pressure), in mechanically ventilated patients may assist in identifying patients at risk of weaning failure. Recently, the association of conventional echocardiography and lung ultrasound showed promising results for the prediction of post extubation distress. Speckle Tracking is an emerging tool in intensive care medicine that has never been investiguated for the prediction of weaning failure. It could early detects diastolic dysfunction and and elevated filling pressure. Of more, speckle tracking is known to be less operator dependant. The main objective of our study is to evaluate the diagnosis accuracy of speckle tracking echocardiography performed during a weaning trial to predict weaning failure. The secondary objectives are to assess the diagnosis accuracy of combined heart and lung ultrasound to predict weaning failure.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

August 31, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

7 years

First QC Date

August 31, 2018

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • lung and heart ultrasounds

    Area under the receiver operator characteristic curve (AUC) of global longitudinal strain and strain rate variations (before and during a weaning trial) to predict weaning failure.

    Just before and during the weaning trial

Study Arms (2)

Resuscitation patients

EXPERIMENTAL
Other: echocardiography

healthy volunteers

ACTIVE COMPARATOR
Other: echocardiography

Interventions

Speckle tracking echocardiography

Resuscitation patientshealthy volunteers

Eligibility Criteria

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

You may qualify if:

  • \- Patients hospitalized in intensive care unit under mechanical fulfilling the criteria of ventilation weaning trial.

You may not qualify if:

  • Less than 18 years old.
  • Pregnancy
  • Non sinusal cardiac rhythm
  • Neuro Myopathy
  • Tracheotomy
  • Lack of echogenicity to perform at least a four chamber apical view

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13015, France

RECRUITING

Study Officials

  • Jean-Olivier ARNAUD

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 5, 2018

Study Start

May 20, 2019

Primary Completion

May 21, 2026

Study Completion

May 21, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations