ECHODIA: Sonographic Evaluation of Diaphragmatic Function in Critical Care Patients With Use of Non Invasive Ventilation

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT02380547
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Critical Care; Invasive Mechanical Ventilation	Other: Sonographic diaphragmatic measurements

Study Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Sonographic Evaluation of Diaphragmatic Function in Critical Care Patients With Use of Non Invasive Ventilation
• Actual Study Start Date: Jun 19, 2015
• Actual Primary Completion Date: Jul 15, 2016
• Actual Study Completion Date: Jul 15, 2016

Outcome Measures

Primary Outcome Measures

1. Diaphragmatic excursion [Before the first NIV session]

2. Diaphragmatic thickening [Before the first NIV session]

3. Diaphragmatic excursion [After the first NIV session]

4. Diaphragmatic thickening [After the first NIV session]

5. Diaphragmatic excursion [After 24 h of NIV use]

6. Diaphragmatic thickening [After 24 h of NIV use]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service d'anesthésie- réanimation chirurgicale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg		France	67091

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

• Principal Investigator: Gharib AJOB, MD, Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT02380547
• Other Study ID Numbers: 5957
• First Posted: Mar 5, 2015
• Last Update Posted: Mar 22, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by University Hospital, Strasbourg, France: Sonography; Diaphragmatic function; Non invasive ventilation; Critical care patients; Extubation after 24 hours of invasive ventilation

Study Results

No Results Posted as of Mar 22, 2018