NCT03261440

Brief Summary

Weaning patients off ventilation in an ICU is sometimes difficult, because of three major inter-related etiologies: impaired lung, heart and diaphragm function. In this context, ultrasonography during tests to wean patients off ventilation could make it possible to diagnose cardiac dysfunction, a loss of pulmonary aeration or diaphragm dysfunction and thus reduce the number of failures at extubation. The study will be carried out in 100 patients on mechanical ventilation following abdominal or heart surgery, who will have echocardiography, and pulmonary and diaphragm ultrasonography.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

November 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 23, 2017

Last Update Submit

August 23, 2017

Conditions

Mechanical VentilationFollowing Heart or Abdominal Surgery

Outcome Measures

Primary Outcomes (3)

  • Echocardiography

    At baseline

  • Lung ultrasonography

    At baseline

  • Diaphragm ultrasonography

    At baseline

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients on post-operative mechanical ventilation following heart or abdominal surgery

You may qualify if:

  • Patients on mechanical ventilation for at least 48 hours
  • Age ≥ 60 years
  • Patients who have undergone abdominal or heart surgery

You may not qualify if:

  • Patients with a known neuromuscular disease
  • Patients younger than 60 years
  • Duration of mechanical ventilation \<48h
  • Non-surgical patients
  • Patients with severe COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

RECRUITING

Related Publications (1)

  • Bouhemad B, Mojoli F, Nowobilski N, Hussain A, Rouquette I, Guinot PG, Mongodi S. Use of combined cardiac and lung ultrasound to predict weaning failure in elderly, high-risk cardiac patients: a pilot study. Intensive Care Med. 2020 Mar;46(3):475-484. doi: 10.1007/s00134-019-05902-9. Epub 2020 Jan 8.

    PMID: 31915837DERIVED

Central Study Contacts

Belaïd BOUHEMAD

CONTACT

03.80.29.93.42belaid.bouhemad@chu-dijon.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

November 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations

FR(1)