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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Pressure Extubation | Active Comparator | Positive pressure extubation is used for patients in this group. |
|
| Traditional Extubation | Active Comparator | Traditional extubation is used for patients in this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive pressure extubation | Procedure | Positive pressure ventilation without endotracheal aspiration/suction during extubation procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence/A presence/absence of complications after extubation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumonia | Presence of fever, leukocytosis, purulent secretions and a new pulmonary infiltrate on chest radiography | 72 hours |
| Reintubation | Intubation requirement after extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mauro F Andreu, PT | Contact | 54 11 156878298 | maufede@hotmail.com | |
| Marco G Bezzi, PT | Contact | 54 11 1550620219 | bezzi.marco@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mauro F Andreu, PT | Hospital D. F. Santojanni | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Santojanni | Recruiting | Buenos Aires | 1408 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25425709 | Background | Andreu MF, Salvati IG, Donnianni MC, Ibanez B, Cotignola M, Bezzi M. Effect of applying positive pressure with or without endotracheal suctioning during extubation: a laboratory study. Respir Care. 2014 Dec;59(12):1905-11. doi: 10.4187/respcare.03121. Epub 2014 Nov 25. | |
| 30914493 | Derived | Andreu MF, Dotta ME, Bezzi MG, Borello S, Cardoso GP, Dib PC, Garcia Schustereder SL, Galloli AM, Castro DR, Di Giorgio VL, Villalba FJ, Bertozzi MN, Carballo JM, Martin MC, Brovia CC, Pita MC, Pedace MP, De Benedetto MF, Delli Carpini J, Aguirre P, Montero G. Safety of Positive Pressure Extubation Technique. Respir Care. 2019 Aug;64(8):899-907. doi: 10.4187/respcare.06541. Epub 2019 Mar 26. |
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Non-inferiority trial
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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.
| Traditional during extubation | Procedure | Spontaneous ventilation with endotracheal aspiration/suction during extubation procedure. |
|
| 72 hours |