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

NCT ID: NCT02123940

Last Updated: 2019-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

483 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-08-25

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

Conditions

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Adult Patients Ventilated More Than 48 h

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nasal humidified high flow therapy

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

Group Type EXPERIMENTAL

lung ultrasound score

Intervention Type DEVICE

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

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

Group Type OTHER

lung ultrasound score

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pitié-Salpêtrière Hospital

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role collaborator

University Hospital, Marseille

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien PERBET

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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2013-A01458-37

Identifier Type: -

Identifier Source: secondary_id

CHU-0187

Identifier Type: -

Identifier Source: org_study_id

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