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

Study Overview
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Brief Summary
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Prospective, randomized clinical multicentric study in ICU during weaning from mechanical ventilation.

Detailed Description
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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

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

Conditions
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Adult Patients Ventilated More Than 48 h

Intervention / Treatment
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* Device: lung ultrasound score


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nasal humidified high flow therapy<br>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 | Device: lung ultrasound score<br>* 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<br>|
| Other: standard strategy<br>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 | Device: lung ultrasound score<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postextubation distress | postextubation period requiring a ventilatory support (reintubation or curative Noninvasive ventilation). | during 48 hour (at day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Extubation failure within the 7 days following planned extubation | at day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weaning from mechanical ventilation, Lung ultrasound, Nasal humidified high flow therapy, Weaning failure, Postextubation distress