Is Positive Pressure Extubation a Safe Procedure?

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-12-31

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).

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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.

Conditions

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Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-inferiority trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The pre and post extubation parameters are recorded by an outcome assessor who do not know the assigned extubation method.

The assigned extubation method is coded to minimize potential bias during data analysis.

Study Groups

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Positive Pressure Extubation

Positive pressure extubation is used for patients in this group.

Group Type ACTIVE_COMPARATOR

Positive pressure extubation

Intervention Type PROCEDURE

Positive pressure ventilation without endotracheal aspiration/suction during extubation procedure.

Traditional Extubation

Traditional extubation is used for patients in this group.

Group Type ACTIVE_COMPARATOR

Traditional during extubation

Intervention Type PROCEDURE

Spontaneous ventilation with endotracheal aspiration/suction during extubation procedure.

Interventions

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Positive pressure extubation

Positive pressure ventilation without endotracheal aspiration/suction during extubation procedure.

Intervention Type PROCEDURE

Traditional during extubation

Spontaneous ventilation with endotracheal aspiration/suction during extubation procedure.

Intervention Type PROCEDURE

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.