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Due to the outbreak of the SARS-CoV-2 pandemic in Argentina and the lack of information about the potential risks of contamination from extubation and aerosolization, we stopped recruiting patients before achieving the predefined sample size.
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| Name | Class |
|---|---|
| MatÃas Bertozzi | UNKNOWN |
| Marco Bezzi | UNKNOWN |
| Borello, Silvina, M.D. | INDIV |
| Daniela Castro |
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Orotracheal extubation consists in the removal of the endotracheal tube (ETT) when it is no longer required. This procedure may carry a considerable risk of complications and extubation failure. The literature points out two methods of extubation: the traditional method and the positive pressure method.
In a noninferiority clinical trial it was demonstrated that EOT with positive pressure and without endotracheal suction was a safe technique and could be better than traditional extubation. Although prior studies reported better clinical outcomes with the positive pressure extubation technique, its superiority has not been deeply studied yet. Therefore, the objective of our study is to determine whether the positive pressure OTE technique, compared with the traditional OTE technique, reduces the incidence of major postextubation complications (up to 60 minutes) in critically ill adult patients.
Design: Multicenter randomized controlled clinical trial Methods: Critically ill adult subjects on invasive mechanical ventilation who met extubation criteria will be included. Will be randomly assigned to positive-pressure extubation (n=389) or to traditional extubation (n=389).
The main variable will be incidence of major complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Pressure Extubation Technique | Experimental | ETT is removed in PSV 15/10 mode and without endotracheal suction. |
|
| Traditional Extubation Technique | Active Comparator | ETT is removed with continuous endotracheal suction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Pressure Extubation Technique | Procedure | Positive-pressure extubation is performed by only one operator. Ventilator parameters are set to pressure support ventilation mode, with an inspiratory pressure of 15 cm H2O and PEEP of 10 cm H2O. Then, the cuff is deflated, and the ETT is removed without endotracheal suction. Once the ETT is removed, a suction catheter is introduced through the mouth to suction secretions drawn to the oropharynx by the air flow from the ventilator passing between the ETT and the larynx. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Post Extubation Complications | Clinical evidence of at least one of the following:
| Within15 minutes after extubation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Minor Post Extubation Complications | Clinical evidence of at least one of the following:
| Hypertension, Tachycardia, Tachypnea or Poor Respiratory Mechanics, within 15 minutes after extubation. Bronchospasm, Severe cough or Post Obstructive Pulmonary Edema, within 60 minutes after extubation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauro F Andreu, Prof | Hospital Santojanni | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Santojanni | 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 | Background | 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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Patients with a history of upper airway (UA) injury or surgery, with a limited therapeutic effort, who had previously been extubated or tracheostomized, or who had required noninvasive mechanical ventilation (NIMV) as a weaning method were excluded from our study. A total of 2567 patients met the eligibility criteria, 1842 were excluded from the study, and 725 were randomly assigned to the traditional extubation group (n=358) and positive pressure extubation group (n=367).
Patients admitted to the ICU, Emergency Unit or Coronary Unit between April 1, 2019, and March 26, 2020, were included in the analysis. We included patients aged > 18 years, requiring invasive mechanical ventilation through an ETT, who had successfully completed a spontaneous breathing trial and met the following OTE criteria: an adequate level of consciousness and effective cough (cough at order and/or at endotracheal suctioning). Informed consent was also required.
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| ID | Title | Description |
|---|---|---|
| FG000 | Positive Pressure Extubation Technique | ETT is removed in PSV 15/10 mode and without endotracheal suction. Positive Pressure Extubation Technique: Positive-pressure extubation is performed by only one operator. Ventilator parameters are set to pressure support ventilation mode, with an inspiratory pressure of 15 cm H2O and PEEP of 10 cm H2O. Then, the cuff is deflated, and the ETT is removed without endotracheal suction. Once the ETT is removed, a suction catheter is introduced through the mouth to suction secretions drawn to the oropharynx by the air flow from the ventilator passing between the ETT and the larynx. |
| FG001 | Traditional Extubation Technique | ETT is removed with continuous endotracheal suction Traditional Extubation Technique: Traditional extubation is performed by 2 operators. Without reconnection to the ventilator, the closed suction system catheter is introduced by one of the operators into the ETT and suctioning is initiated. The cuff is immediately deflated by the other operator, and the ETT is removed with continuous endotracheal suction during the whole procedure by the first operator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Pressure Extubation Technique | ETT is removed in PSV 15/10 mode and without endotracheal suction. Positive Pressure Extubation Technique: Positive-pressure extubation is performed by only one operator. Ventilator parameters are set to pressure support ventilation mode, with an inspiratory pressure of 15 cm H2O and PEEP of 10 cm H2O. Then, the cuff is deflated, and the ETT is removed without endotracheal suction. Once the ETT is removed, a suction catheter is introduced through the mouth to suction secretions drawn to the oropharynx by the air flow from the ventilator passing between the ETT and the larynx. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Major Post Extubation Complications | Clinical evidence of at least one of the following:
| Posted | Count of Participants | Participants | Within15 minutes after extubation. |
|
72 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Positive Pressure Extubation Technique | ETT is removed in PSV 15/10 mode and without endotracheal suction. Positive Pressure Extubation Technique: Positive-pressure extubation is performed by only one operator. Ventilator parameters are set to pressure support ventilation mode, with an inspiratory pressure of 15 cm H2O and PEEP of 10 cm H2O. Then, the cuff is deflated, and the ETT is removed without endotracheal suction. Once the ETT is removed, a suction catheter is introduced through the mouth to suction secretions drawn to the oropharynx by the air flow from the ventilator passing between the ETT and the larynx. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Mauro Andreu | Hospitalsantojanni | +541168788298 | mfandreu@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2019 | Dec 28, 2020 | Prot_SAP_000.pdf |
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| UNKNOWN |
| Victoria Di Giorgio | UNKNOWN |
| Mariana Aguirre | UNKNOWN |
| Karina Miralles | UNKNOWN |
| Diego Noval | UNKNOWN |
| Sebastián Fredes | UNKNOWN |
| Eliana Wilhelm | AMBIG |
| Mauricio Zakimchuk | UNKNOWN |
| Julián Buffarini Cignoli | UNKNOWN |
| Mariana Bernardini | UNKNOWN |
| Leticia Rey | UNKNOWN |
| Valeria Pieroni | UNKNOWN |
| Pablo D´Annunzio | UNKNOWN |
| Gustavo Plotnikow | UNKNOWN |
| Romina Prato | UNKNOWN |
| MatÃas Lompizano | UNKNOWN |
| MarÃa Guaymas | UNKNOWN |
| MatÃas Accoce | UNKNOWN |
| Javier Dorado | UNKNOWN |
| Gimena Cardoso | UNKNOWN |
| Patricia Torres | UNKNOWN |
| Vanesa Pavlotsky | UNKNOWN |
| Emiliano Navarro | AMBIG |
| Eliana Markman | AMBIG |
| Paula Di Nardo | UNKNOWN |
| Ivonne Kunzi Steyer | UNKNOWN |
| Thomsen, Carolina, M.D. | INDIV |
| Cecilia Palacios | UNKNOWN |
| Mariela Davies | UNKNOWN |
| Mercedes Ruffo | UNKNOWN |
| Victoria Leon | UNKNOWN |
| Fernando Tapia | UNKNOWN |
superiority
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Due to the nature of the intervention, blinding of the subject and the operators responsible for extubation is not possible. The person in charge of data statistical analysis and the evaluator who assess and record outcome measures will be blinded to the allocated intervention.
|
| Traditional Extubation Technique | Procedure | Traditional extubation is performed by 2 operators. Without reconnection to the ventilator, the closed suction system catheter is introduced by one of the operators into the ETT and suctioning is initiated. The cuff is immediately deflated by the other operator, and the ETT is removed with continuous endotracheal suction during the whole procedure by the first operator. |
|
| Number of Participants With Overall Post Extubation Complications | Clinical evidence of at least one of the following:
| Upper airway obstruction, Desaturation, Vomiting, Hypertension, Tachycardia, Tachypnea, Poor Respiratory Mechanics, within 15 minutes after extubation. Bronchospasm, Severe cough or Post Obstructive Pulmonary Edema, within 60 minutes after extubation. |
| Number of Participants With Post Extubation Pneumonia | Presence of a new radiographic infiltrate or progression of infiltrates prior to extubation and any of the following: fever, leukocytosis (greater than 10,000 / mm3) or leukopenia (less than 4,000 / mm3) compared to the value prior to extubation and increase in the amount or change in the quality of tracheobronchial secretions. | Within 72 hours after extubation. |
| Number of Participants With Extubation Failure | Use of Non Invasive Ventilation to treat the failure or need of reintubation. | Within 72 hours after extubation. |
| Number of Participants That Required Reintubation | Need of reintubation. | Within 72 hours after extubation. |
| BG001 | Traditional Extubation Technique | ETT is removed with continuous endotracheal suction Traditional Extubation Technique: Traditional extubation is performed by 2 operators. Without reconnection to the ventilator, the closed suction system catheter is introduced by one of the operators into the ETT and suctioning is initiated. The cuff is immediately deflated by the other operator, and the ETT is removed with continuous endotracheal suction during the whole procedure by the first operator. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| High Risk of Extubation Failure | High risk of extubation failure was defined as the presence of at least one of the following criteria: age ≥66 years, moderate or severe COPD, >1 comorbidities, body mass index >30, congestive heart failure as main reason from IMV, difficult intubation, IMV >7 days, a requirement of suctioning respiratory secretions (>2 suctions within 4 h before the orotracheal extubation (OTE)), difficult or prolonged weaning and/or APACHE II (Acute Physiology and Chronic Health disease Classification System II) a day before the OTE >12. | Count of Participants | Participants |
|
| OG001 | Traditional Extubation Technique | ETT is removed with continuous endotracheal suction Traditional Extubation Technique: Traditional extubation is performed by 2 operators. Without reconnection to the ventilator, the closed suction system catheter is introduced by one of the operators into the ETT and suctioning is initiated. The cuff is immediately deflated by the other operator, and the ETT is removed with continuous endotracheal suction during the whole procedure by the first operator. |
|
|
| Secondary | Number of Participants With Minor Post Extubation Complications | Clinical evidence of at least one of the following:
| Posted | Count of Participants | Participants | Hypertension, Tachycardia, Tachypnea or Poor Respiratory Mechanics, within 15 minutes after extubation. Bronchospasm, Severe cough or Post Obstructive Pulmonary Edema, within 60 minutes after extubation. |
|
|
|
| Secondary | Number of Participants With Overall Post Extubation Complications | Clinical evidence of at least one of the following:
| Posted | Count of Participants | Participants | Upper airway obstruction, Desaturation, Vomiting, Hypertension, Tachycardia, Tachypnea, Poor Respiratory Mechanics, within 15 minutes after extubation. Bronchospasm, Severe cough or Post Obstructive Pulmonary Edema, within 60 minutes after extubation. |
|
|
|
| Secondary | Number of Participants With Post Extubation Pneumonia | Presence of a new radiographic infiltrate or progression of infiltrates prior to extubation and any of the following: fever, leukocytosis (greater than 10,000 / mm3) or leukopenia (less than 4,000 / mm3) compared to the value prior to extubation and increase in the amount or change in the quality of tracheobronchial secretions. | Posted | Count of Participants | Participants | Within 72 hours after extubation. |
|
|
|
| Secondary | Number of Participants With Extubation Failure | Use of Non Invasive Ventilation to treat the failure or need of reintubation. | Posted | Count of Participants | Participants | Within 72 hours after extubation. |
|
|
|
| Secondary | Number of Participants That Required Reintubation | Need of reintubation. | Posted | Count of Participants | Participants | Within 72 hours after extubation. |
|
|
|
| 41 |
| 363 |
| 0 |
| 363 |
| 0 |
| 363 |
| EG001 | Traditional Extubation Technique | ETT is removed with continuous endotracheal suction Traditional Extubation Technique: Traditional extubation is performed by 2 operators. Without reconnection to the ventilator, the closed suction system catheter is introduced by one of the operators into the ETT and suctioning is initiated. The cuff is immediately deflated by the other operator, and the ETT is removed with continuous endotracheal suction during the whole procedure by the first operator. | 45 | 345 | 0 | 345 | 0 | 345 |
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