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Is Positive Pressure Extubation a Safe Procedure?

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ClinicalTrials.gov Identifier: NCT03174509
Recruitment Status : Unknown
Verified June 2017 by Mauro Andreu, Hospital Donación Francisco Santojanni.
Recruitment status was:  Recruiting
First Posted : June 2, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Mauro Andreu, 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).

Condition or disease Intervention/treatment Phase
Complication Procedure: Positive pressure extubation Procedure: Traditional during extubation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-inferiority trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Is Positive Pressure Extubation Safe Procedure? A Randomized Non-inferiority Trial.
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pneumonia [ Time Frame: 72 hours ]
    Presence of fever, leukocytosis, purulent secretions and a new pulmonary infiltrate on chest radiography

  2. Reintubation [ Time Frame: 72 hours ]
    Intubation requirement after extubation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174509


Contacts
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Contact: Mauro F Andreu, PT 54 11 156878298 maufede@hotmail.com
Contact: Marco G Bezzi, PT 54 11 1550620219 bezzi.marco@gmail.com

Locations
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Argentina
Hospital Santojanni Recruiting
Buenos Aires, Argentina, 1408
Contact: Mauro F Andreu, PT    54 11 1568788298    maufede@hotmail.com   
Contact: Marco G Bezzi, PT    54 11 1550620219    bezzi.marco@gmail.com   
Sponsors and Collaborators
Hospital Donación Francisco Santojanni
Investigators
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Principal Investigator: Mauro F Andreu, PT Hospital D. F. Santojanni

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mauro Andreu, Physical Therapist, Hospital Donación Francisco Santojanni
ClinicalTrials.gov Identifier: NCT03174509     History of Changes
Other Study ID Numbers: HGADFS14012016-01
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mauro Andreu, Hospital Donación Francisco Santojanni:
airway extubation
positive-pressure respiration
suction
ventilator weaning