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

Study Overview
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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.

Official Title
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Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation in Obese or High-Risk Patients. A Randomized Clinical Trial.

Conditions
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Extubation Failure

Intervention / Treatment
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* Device: Preventive Conditioned NIV Therapy after planned extubation
* Device: Preventive HFOT after planned extubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conditioned NIV in High Risk Patients<br> | Device: Preventive Conditioned NIV Therapy after planned extubation<br>* Conditioned NIV during 48 hours following extubation.<br>|
| Active Comparator: HFOT in High Risk Patients<br> | Device: Preventive HFOT after planned extubation<br>* HFOT set according to patients tolerance during 48 hours following extubation<br>|
| Experimental: Conditioned NIV in Obese Intermediate Risk Patients<br> | Device: Preventive Conditioned NIV Therapy after planned extubation<br>* Conditioned NIV during 48 hours following extubation.<br>|
| Active Comparator: HFOT in Obese Intermediate Risk Patient<br> | Device: Preventive HFOT after planned extubation<br>* HFOT set according to patients tolerance during 48 hours following extubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation rate |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care Unit mortality rate |  | 3 months | 
| Hospital mortality rate |  | 3 months | 
| Intensive Care Unit length of stay |  | 3 months | 
| Hospital length of stay |  | 6 months | 
| Respiratory infection rate |  | 6 months |