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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02380547
Other study ID # 5957
Secondary ID
Status Completed
Phase
First received February 23, 2015
Last updated March 21, 2018
Start date June 19, 2015
Est. completion date July 15, 2016

Study information

Verified date March 2018
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Usefulness of non invasive ventilation in patients extubated after more than 48 hours of invasive ventilation is still in debate except for specific patients (chronic pulmonary disease and chronic heart failure).

Many experimental and clinical studies have shown that diaphragmatic function is depressed by mechanical ventilation in intubated patients.

The investigators will test the hypothesis that non invasive ventilation after extubation may improve diaphragmatic function


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 15, 2016
Est. primary completion date July 15, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient extubated after at least 48 hours of invasive ventilation

- Requiring non invasive ventilation

- Consent of patient

Exclusion Criteria:

- Diaphragmatic paralysis

- Neuromuscular disease

- significant pleural effusion

- atelectasis requiring bronchoscopy

- abdominal hypertension

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sonographic diaphragmatic measurements


Locations

Country Name City State
France Service d'anesthésie- réanimation chirurgicale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diaphragmatic excursion Before the first NIV session
Primary Diaphragmatic thickening Before the first NIV session
Primary Diaphragmatic excursion After the first NIV session
Primary Diaphragmatic thickening After the first NIV session
Primary Diaphragmatic excursion After 24 h of NIV use
Primary Diaphragmatic thickening After 24 h of NIV use
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