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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ICU Viars, Pitié-Salpétrière Hospital, Paris, France
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01702779
First received: April 24, 2012
Last updated: October 5, 2012
Last verified: October 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lung ultrasound score [ Time Frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation ] [ Designated as safety issue: Yes ]
  • rates of patients with postextubation distress [ Time Frame: during the 48th post-extubation ] [ Designated as safety issue: Yes ]
  • Electrical Impedance tomography [ Time Frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation ] [ Designated as safety issue: Yes ]
  • Epithelial and endothelial biomarkers [ Time Frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702779

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
ICU Viars, Pitié-Salpétrière Hospital, Paris, France
Investigators
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01702779     History of Changes
Other Study ID Numbers: CHU-0107
Study First Received: April 24, 2012
Last Updated: October 5, 2012
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on October 20, 2014