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Nasal Humidified High Flow Oxygen During Weaning From Mechanical Ventilation : Ultrasonography Study (HiFloLUS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01702779
First Posted: October 8, 2012
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pitié-Salpêtrière Hospital
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose
This is a prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.

Condition Intervention
Adult Patients Ventilated More Than 48 h Stable Respiratory and Hemodynamic Conditions for SBT Consent of Patients Arterial Line Other: mechanical ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • variations of lung ultrasound score [ Time Frame: 24 hours after extubation ]

Secondary Outcome Measures:
  • Lung ultrasound score [ Time Frame: 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 ]
  • Electrical Impedance tomography [ Time Frame: 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 ]

Enrollment: 80
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
optiflow Other: mechanical ventilation
Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
O2 Other: mechanical ventilation
Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702779


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Pitié-Salpêtrière Hospital
Investigators
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01702779     History of Changes
Other Study ID Numbers: CHU-0107
First Submitted: April 24, 2012
First Posted: October 8, 2012
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by University Hospital, Clermont-Ferrand:
Weaning from mechanical ventilation
Lung ultrasound
Oxygen inhalation therapy