Is Positive Pressure Extubation a Safe Procedure?

June 1, 2017 updated by: Mauro Andreu, Hospital Donación Francisco Santojanni

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1408
        • Recruiting
        • Hospital Santojanni
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence/A presence/absence of complications after extubation
Time Frame: 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.
60 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Donación Francisco Santojanni

Investigators

  • Principal Investigator: Mauro F Andreu, PT, Hospital D. F. Santojanni

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (Actual)

June 2, 2017

Study Record Updates

Last Update Posted (Actual)

June 5, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HGADFS14012016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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