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
|Condition or disease||Intervention/treatment||Phase|
|Complication||Procedure: Positive pressure extubation Procedure: Traditional during extubation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Non-inferiority trial|
|Masking:||Double (Investigator, Outcomes Assessor)|
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.
|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|
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.
- 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.
- Pneumonia [ Time Frame: 72 hours ]Presence of fever, leukocytosis, purulent secretions and a new pulmonary infiltrate on chest radiography
- Reintubation [ Time Frame: 72 hours ]Intubation requirement after extubation
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
|Contact: Mauro F Andreu, PT||54 11 email@example.com|
|Contact: Marco G Bezzi, PT||54 11 firstname.lastname@example.org|
|Buenos Aires, Argentina, 1408|
|Contact: Mauro F Andreu, PT 54 11 1568788298 email@example.com|
|Contact: Marco G Bezzi, PT 54 11 1550620219 firstname.lastname@example.org|
|Principal Investigator:||Mauro F Andreu, PT||Hospital D. F. Santojanni|