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

Arterial Line Clinical Trial

— HiFloLUS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702779
• Other study ID #: CHU-0107
• 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

• Adult Patients Ventilated More Than 48 h
• Arterial Line
• Consent of Patients
• Stable Respiratory and Hemodynamic Conditions for SBT

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