Weaning FailureExtubARNCT03918811
Comparison of Two Extubation Techniques in Critically Ill Adult Patients
A study testing Positive Pressure Extubation Technique and Traditional Extubation Technique in people with Weaning Failure and Mechanical Ventilation Complication, run by Hospital Donación Francisco Santojanni at 1 site in Argentina.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure, Mechanical Ventilation Complication
- What is being tested?
- Positive Pressure Extubation Technique and Traditional Extubation Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 725 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Apr 2019to 26 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Invasive mechanical ventilation through an endotracheal tube,
- Successfully complete a spontaneous breathing trial
- Adequate level of consciousness (Glasgow Coma Score >8)
- Effective cough.
- Written informed consent from a relative or legal representative.
Who cannot join
- History of upper airway injury or surgery
- Previously extubated or tracheostomized
- Noninvasive ventilation (NIV) as a weaning method
- Decision to not reanimate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Extubation Techniques in Critically Ill Adult Patients (ExtubAR Trial): Randomized Clinical Trial
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.
Read the detailed description
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.
- Being tested
- Positive Pressure Extubation Technique, Traditional Extubation Technique
- Keywords
- airway extubation, extubation methods, positive pressure, positive-pressure extubation, tracheal extubation, positive-pressure ventilation, extubation complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Pressure Extubation TechniqueProcedure or surgery
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.
Traditional Extubation TechniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive Pressure Extubation Technique | Experimental | ETT is removed in PSV 15/10 mode and without endotracheal suction. Receives: Procedure: Positive Pressure Extubation Technique |
| Traditional Extubation Technique | Active comparator | ETT is removed with continuous endotracheal suction Receives: Procedure: Traditional Extubation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Post Extubation Complications
Clinical evidence of at least one of the following:
- Upper airway obstruction
- Desaturation
- Vomiting
Measured: Within15 minutes after extubation.
Secondary outcomes (5)
Number of Participants With Minor Post Extubation Complications
Clinical evidence of at least one of the following:
- Hypertension
- Tachycardia
- Tachypnea
- Poor respiratory mechanics
- Bronchospasm
- Severe cough
- Post obstructive pulmonary edema
Measured: 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.
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
- Bronchospasm
- Severe cough
- Post obstructive pulmonary edema
Measured: 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.
Measured: Within 72 hours after extubation.
Number of Participants With Extubation Failure
Use of Non Invasive Ventilation to treat the failure or need of reintubation.
Measured: Within 72 hours after extubation.
Number of Participants That Required Reintubation
Need of reintubation.
Measured: Within 72 hours after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Apr 2019
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- superiority
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Donación Francisco Santojanni
- Sponsor type
- University, hospital or other
- Collaborators
- Matías Bertozzi, Marco Bezzi, Borello, Silvina, M.D., Daniela Castro, Victoria Di Giorgio, Mariana Aguirre, Karina Miralles, Diego Noval, Sebastián Fredes, Eliana Wilhelm, Mauricio Zakimchuk, Julián Buffarini Cignoli, Mariana Bernardini, Leticia Rey, Valeria Pieroni, Pablo D´Annunzio, Gustavo Plotnikow, Romina Prato, Matías Lompizano, María Guaymas, Matías Accoce, Javier Dorado, Gimena Cardoso, Patricia Torres, Vanesa Pavlotsky, Emiliano Navarro, Eliana Markman, Paula Di Nardo, Ivonne Kunzi Steyer, Thomsen, Carolina, M.D., Cecilia Palacios, Mariela Davies, Mercedes Ruffo, Victoria Leon, Fernando Tapia
- Responsible party
- Principal investigator, Mauro Andreu, Hospital Donación Francisco Santojanni
- Investigators
- Mauro F Andreu, Prof, Principal investigator, Hospital Santojanni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918811
- Sponsor's protocol ID
- 12-2018-05
- Acronym
- ExtubAR
- Status last verified
- Jan 2021
- First submitted
- 14 Apr 2019
- Last updated
- 9 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25425709Andreu 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.
PubMed 30914493
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Extubation Techniques in Critically Ill Adult Patients (ExtubAR Trial): Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03918811
- Acronym / sponsor ID
- ExtubAR / 12-2018-05
- Keywords
- airway extubation, extubation methods, positive pressure, positive-pressure extubation, tracheal extubation, positive-pressure ventilation, extubation complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 725 participants (actual)
- Lead sponsor
- Hospital Donación Francisco SantojanniUniversity, hospital or other
- Collaborators
- Matías Bertozzi, Marco Bezzi, Borello, Silvina, M.D., Daniela Castro, Victoria Di Giorgio, Mariana Aguirre, Karina Miralles, Diego Noval, Sebastián Fredes, Eliana Wilhelm, Mauricio Zakimchuk, Julián Buffarini Cignoli, Mariana Bernardini, Leticia Rey, Valeria Pieroni, Pablo D´Annunzio, Gustavo Plotnikow, Romina Prato, Matías Lompizano, María Guaymas, Matías Accoce, Javier Dorado, Gimena Cardoso, Patricia Torres, Vanesa Pavlotsky, Emiliano Navarro, Eliana Markman, Paula Di Nardo, Ivonne Kunzi Steyer, Thomsen, Carolina, M.D., Cecilia Palacios, Mariela Davies, Mercedes Ruffo, Victoria Leon, Fernando Tapia
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Posted 9 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- superiority
| Arm | Type | Receives |
|---|---|---|
| Positive Pressure Extubation Technique | Experimental | Procedure: Positive Pressure Extubation TechniqueETT is removed in PSV 15/10 mode and without endotracheal suction. |
| Traditional Extubation Technique | Active comparator | Procedure: Traditional Extubation TechniqueETT is removed with continuous endotracheal suction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18
- Invasive mechanical ventilation through an endotracheal tube,
- Successfully complete a spontaneous breathing trial
- Adequate level of consciousness (Glasgow Coma Score >8)
- Effective cough.
Key exclusion criteria (4 listed)
- History of upper airway injury or surgery
- Previously extubated or tracheostomized
- Noninvasive ventilation (NIV) as a weaning method
- Decision to not reanimate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Pressure Extubation TechniquePositive-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. | Procedure or surgery | Positive Pressure Extubation Technique |
| Traditional Extubation TechniqueTraditional 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. | Procedure or surgery | Traditional Extubation Technique |
Primary outcome
Number of Participants With Major Post Extubation Complications
Time frame: Within15 minutes after extubation.
Clinical evidence of at least one of the following: * Upper airway obstruction * Desaturation * Vomiting
5 secondary outcomes
Number of Participants With Minor Post Extubation Complications
Time frame: 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.
Number of Participants With Overall Post Extubation Complications
Time frame: 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
Time frame: Within 72 hours after extubation.
Number of Participants With Extubation Failure
Time frame: Within 72 hours after extubation.
Number of Participants That Required Reintubation
Time frame: Within 72 hours after extubation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25425709Andreu 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.
- Background: PubMed 30914493Andreu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro F Andreu, Prof principal investigator
Hospital Santojanni
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Pressure Extubation Technique and Traditional Extubation Technique in people with Weaning Failure and Mechanical Ventilation Complication, run by Hospital Donación Francisco Santojanni at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Major Post Extubation Complications (time frame: Within15 minutes after extubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03918811, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.