Arterial Line Clinical Trial
— HiFloLUSVerified date | November 2014 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
This is a prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | ICU Viars, Pitié-Salpétrière Hospital, Paris, France |
France,
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 |
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