Is Positive Pressure Extubation a Safe Procedure?

Study Overview
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Brief Summary
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Laboratory studies suggest extubation with positive pressure because it reduces the volume of secretions filtered into the distal airway. The aim of this non inferiority study is to evaluate the safety of the extubation technique under positive pressure with respect to the traditional technique (with suction and without positive pressure in the airways).

Detailed Description
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The extubation procedure consists of the removal of the endotracheal tube when it is no longer required. The literature reports two methods of extubation: the named traditional method (with suction and without positive pressure in the airways) and the positive pressure method. Laboratory studies suggest extubation at positive pressure because it reduces the volume of secretions filtered into the distal airway. Prior to apply it into clinical practice the investigators of this study consider is a priority to guarantee the safety of the positive pressure extubation method in terms of presence of complications. The aim of this non-inferiority study is to compare the incidence of complications between both extubation techniques in adult patients with invasive mechanical ventilation. The hypothesis of this study is that applying positive pressure during cuff deflation and extubation is not inferior to the traditional method in the incidence of complications.

Official Title
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Is Positive Pressure Extubation Safe Procedure? A Randomized Non-inferiority Trial.

Conditions
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Complication

Intervention / Treatment
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* Procedure: Positive pressure extubation
* Procedure: Traditional during extubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasive Mechanical Ventilation with endotracheal tube. 18 years and older. Successful 30 minutes spontaneous breathing trial (SBT). Extubation Criteria. Informed consent. Exclusion Criteria: Previous airway surgery or injury. Non-Invasive Ventilation as weaning method.

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
Interventional Model Description: Non-inferiority trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Positive Pressure Extubation<br>Positive pressure extubation is used for patients in this group. | Procedure: Positive pressure extubation<br>* Positive pressure ventilation without endotracheal aspiration/suction during extubation procedure.<br>|
| Active Comparator: Traditional Extubation<br>Traditional extubation is used for patients in this group. | Procedure: Traditional during extubation<br>* Spontaneous ventilation with endotracheal aspiration/suction during extubation procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/A presence/absence of complications after extubation | Clinical Evidence of at least one of the next complications: persistent cough, airway obstruction, post-obstructive pulmonary edema, bronchospasm, desaturation, vomiting, tachycardia, arterial hypertension. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia | Presence of fever, leukocytosis, purulent secretions and a new pulmonary infiltrate on chest radiography | 72 hours | 
| Reintubation | Intubation requirement after extubation | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway extubation, positive-pressure respiration, suction, ventilator weaning