Is Positive Pressure Extubation a Safe Procedure?

Hospital Donación Francisco Santojanni

Status: Unknown

Conditions: Complication

Treatments: Procedure: Positive pressure extubation; Procedure: Traditional during extubation

Study type: Interventional

Funder types: Other

Identifiers

NCT03174509

HGADFS14012016-01

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups

Positive Pressure Extubation

Active Comparator group

Description:

Positive pressure extubation is used for patients in this group.

Treatment:

Procedure: Positive pressure extubation

Traditional Extubation

Active Comparator group

Description:

Traditional extubation is used for patients in this group.

Treatment:

Procedure: Traditional during extubation