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

  • France
      • 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
Other: mechanical ventilation
Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
Other: O2
Other: mechanical ventilation
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.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Pitié-Salpêtrière Hospital

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

Keywords

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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