Treatment Strategy in Patients With High-risk of Postextubation Distress in ICU Based on a Lung Ultrasound Score Versus Standard Strategy

Phase 3

Completed

• Conditions: Adult Patients Ventilated More Than 48 h
• Interventions: Device: lung ultrasound score

• Registration Number: NCT02123940
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Prospective, randomized clinical multicentric study in ICU during weaning from mechanical ventilation.

Detailed Description

Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-04-11
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-28
• Primary Completion: 2018-08-25
• Study Completion: 2018-08-25
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 483

Inclusion Criteria

• Adult patients ventilated more than 48 h
• Stable respiratory and hemodynamic conditions for SBT
• Consent of patients
• Arterial line

Exclusion Criteria

• severe COBP
• Laryngeal dyspnea
• Tracheostomy
• Arrhythmia
• No echogenicity
• Paraplegia >T8

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nasal humidified high flow therapy	lung ultrasound score	Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy
standard strategy	lung ultrasound score	Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy

Primary Outcome Measures

Name	Time	Method
Incidence of postextubation distress	during 48 hour (at day 1)	postextubation period requiring a ventilatory support (reintubation or curative Noninvasive ventilation).

Secondary Outcome Measures

Name	Time	Method
Number of ventilator-free-days	at day 1 (after extubation)
Length of stay in ICU	at day 1
Mortality in ICU	at day 1
Extubation failure	at day 7	Extubation failure within the 7 days following planned extubation

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France