- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01702779
Nasal Humidified High Flow Oxygen During Weaning From Mechanical Ventilation : Ultrasonography Study (HiFloLUS)
November 28, 2014 updated by: University Hospital, Clermont-Ferrand
This is a prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France
- CHU Clermont-Ferrand
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: optiflow
|
Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
|
Other: O2
|
Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
variations of lung ultrasound score
Time Frame: 24 hours after extubation
|
24 hours after extubation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lung ultrasound score
Time Frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
|
at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
|
rates of patients with postextubation distress
Time Frame: during the 48th post-extubation
|
during the 48th post-extubation
|
Electrical Impedance tomography
Time Frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
|
at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
|
Epithelial and endothelial biomarkers
Time Frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
|
at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
April 24, 2012
First Submitted That Met QC Criteria
October 5, 2012
First Posted (Estimate)
October 8, 2012
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
November 28, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- CHU-0107
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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