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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03261440
Other study ID # KLEIN 2016
Secondary ID
Status Recruiting
Phase N/A
First received August 23, 2017
Last updated August 23, 2017
Start date November 2016
Est. completion date November 2017

Study information

Verified date August 2017
Source Centre Hospitalier Universitaire Dijon
Contact Belaïd BOUHEMAD
Phone 03.80.29.93.42
Email belaid.bouhemad@chu-dijon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Patients on mechanical ventilation for at least 48 hours

- Age = 60 years

- Patients who have undergone abdominal or heart surgery

Exclusion Criteria:

- Patients with a known neuromuscular disease

- Patients younger than 60 years

- Duration of mechanical ventilation <48h

- Non-surgical patients

- Patients with severe COPD

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Echocardiography At baseline
Primary Lung ultrasonography At baseline
Primary Diaphragm ultrasonography At baseline
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