Is Positive Pressure Extubation a Safe Procedure?

Not Applicable

• Conditions: Complication

• Registration Number: NCT03174509
• Lead Sponsor: Hospital Donación Francisco Santojanni

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-30
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Study First Posted: 2017-06-02
• Last Update Posted: 2017-06-05
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pneumonia	72 hours	Presence of fever, leukocytosis, purulent secretions and a new pulmonary infiltrate on chest radiography
Reintubation	72 hours	Intubation requirement after extubation

Trial Locations

Locations (1)

Hospital Santojanni; 🇦🇷 Buenos Aires, Argentina