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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01702779
Other study ID # CHU-0107
Secondary ID
Status Completed
Phase N/A
First received April 24, 2012
Last updated November 28, 2014
Start date August 2011
Est. completion date June 2013

Study information

Verified date November 2014
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

This is a prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.


Description:

Prospective randomized clinical multicentric study on ICU (Intensive Care University) comparing nasal humidified high flow therapy versus standard oxygen with Lung Ultrasound Score during weaning from mechanical ventilation


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients ventilated more than 48 h

- Stable respiratory and hemodynamic conditions for SBT

- Consent of patients

- Arterial line

Exclusion Criteria:

- COBP

- Laryngeal dyspnea

- Tracheostomy

- Arythmya

- No echogenicity

- Paraplegia >T8

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
mechanical ventilation
Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
mechanical ventilation
Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.

Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand ICU Viars, Pitié-Salpétrière Hospital, Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary variations of lung ultrasound score 24 hours after extubation Yes
Secondary Lung ultrasound score at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation Yes
Secondary rates of patients with postextubation distress during the 48th post-extubation Yes
Secondary Electrical Impedance tomography at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation Yes
Secondary Epithelial and endothelial biomarkers at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation Yes
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