Postextubation High-flow Therapy vs Noninvasive Ventilation in Obese or at High-risk Patients

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

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-01

Brief Summary

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The main aim is to demonstrate whether reintubation rate is lower with preventive conditioned noninvasive ventilation (NIV) rather than with High-flow oxygen therapy (HFOT) in obese intermediate-risk patients and in high-risk patients.

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Detailed Description

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Conditions

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Extubation Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Conditioned NIV in High Risk Patients

Group Type EXPERIMENTAL

Preventive Conditioned NIV Therapy after planned extubation

Intervention Type DEVICE

Conditioned NIV during 48 hours following extubation.

HFOT in High Risk Patients

Group Type ACTIVE_COMPARATOR

Preventive HFOT after planned extubation

Intervention Type DEVICE

HFOT set according to patients tolerance during 48 hours following extubation

Conditioned NIV in Obese Intermediate Risk Patients

Group Type EXPERIMENTAL

Preventive Conditioned NIV Therapy after planned extubation

Intervention Type DEVICE

Conditioned NIV during 48 hours following extubation.

HFOT in Obese Intermediate Risk Patient

Group Type ACTIVE_COMPARATOR

Preventive HFOT after planned extubation

Intervention Type DEVICE

HFOT set according to patients tolerance during 48 hours following extubation

Interventions

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Preventive Conditioned NIV Therapy after planned extubation

Conditioned NIV during 48 hours following extubation.

Intervention Type DEVICE

Preventive HFOT after planned extubation

HFOT set according to patients tolerance during 48 hours following extubation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. High-Risk Patients: Patients under mechanical ventilation for more than 24 hours considered at high risk according to the presence of more than 3 of the following risk factors:

* \>65 years.
* Cardiac failure as the primary indication of mechanical ventilation.
* Moderate to severe chronic obstructive pulmonary disease.
* APACHE II \>12 points the extubation day.
* Body mass index \>30.
* Inability to manage respiratory secretions.
* Not simple weaning.
* More than 1 comorbidity.
* More than 7 days under mechanical ventilation.
* Hypercapnia during the spontaneous breathing trial.
* Airway patency problems.
2. Obese Intermediate Risk Patients: Patients under mechanical ventilation for more than 24 hours with a Body mass index \>30 and considered at intermediate risk according to the presence of less than 3 of the following risk factors:

* \>65 years.
* Cardiac failure as the primary indication of mechanical ventilation.
* Moderate to severe chronic obstructive pulmonary disease.
* APACHE II \>12 points the extubation day.
* Inability to manage respiratory secretions.
* Not simple weaning.
* More than 1 comorbidity.
* More than 7 days under mechanical ventilation.
* Airway patency problems.

Exclusion Criteria

* \<18 years.
* Thacheotomized patients.
* Contraindications for NIV (recent facial or cervical trauma/surgery, active gastro-intestinal bleeding, lack of cooperation).
* Unscheduled extubation.
* Do not reintubate orders.
* No informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No