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To evaluate if a rest period before extubation after a successful SBT trial could reduce the extubation failure rate.
Intubation and mechanical ventilation are related with several complications. This increased the risk of mortality of intensive care patients. So, we always look for an early extubation when patients are recovered for the trigger disease. In spite of standardized manoeuvres to decided readiness for extubation these are not quite good because it has been described a failure extubation rate of 5% and a reintubation rate of 15%. Furthermore several risk factors has been associated with a major failure rate:>65 years old, congestive cardiac insufficiency, chronic obstructive pulmonary disease, APACHE II >12 the extubation day, BMI >30, ineffective cough, a lot of bronchial secretions (as the need for >2 endotracheal suctioning in the last 8h before extubation), failure of a previous SBT,alterations of high respiratory tract or intubation for more than 7 days.Patients without any of these factors risk has an extubation failure rate of 10% while if any of these are present extubation failure increase to 30%.
The most used technique as a weaning trial is named spontaneous breathing trial (SBT). Some physiological aspects suggest that breathing through an endotracheal tube could be a really effort trial. So our hypothesis is that a period of rest after SBT and before extubation could reduce the extubation failure rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBT and extubation | No Intervention | After a SBT patients will be extubated as usual | |
| SBT and rest 60 min before extubation | Experimental | After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REST | Procedure | After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Extubation Failure | Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Mortality | up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernandez Rafael, MD, PhD | Althaia Xarxa Assistencial Universitària de Manresa | Principal Investigator |
| Fernandez Maria del Mar, MD, PhD | Hospital Universitari Mutua de Terrassa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospitales: Mutua de Terrassa,Médico-quirúrgico Jaen, Morales Messeguer, General de Albacete, Lorca, Málaga, Santiago, General de Catalunya, Joan XXIII Tarragona, La Fe-Valencia, Bellvitge, Moises Broggi, Mateu Orfila, Reina Sofia, Severo-Ochoa, Delfos | Terrassa | Barcelona | 08221 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28936675 | Derived | Fernandez MM, Gonzalez-Castro A, Magret M, Bouza MT, Ibanez M, Garcia C, Balerdi B, Mas A, Arauzo V, Anon JM, Ruiz F, Ferreres J, Tomas R, Alabert M, Tizon AI, Altaba S, Llamas N, Fernandez R. Reconnection to mechanical ventilation for 1 h after a successful spontaneous breathing trial reduces reintubation in critically ill patients: a multicenter randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1660-1667. doi: 10.1007/s00134-017-4911-0. Epub 2017 Sep 22. |
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Slight number of patients were enrolled after reaching the planned sample due to information delay.
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| ID | Title | Description |
|---|---|---|
| FG000 | SBT and Extubation | After a SBT patients will be extubated as usual |
| FG001 | SBT and Rest 60 Min Before Extubation | After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SBT and Extubation | After a SBT patients will be extubated as usual |
| BG001 | SBT and Rest 60 Min Before Extubation | After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Patients With Extubation Failure | Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation | Posted | Count of Participants | Participants | 48 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 | SBT and Extubation | After a SBT patients will be extubated as usual |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Rafael Fernandez | Althaia Xarxa Assistencial Universitaria de Manresa | 34.8732550 | 3730 | rfernandezf@althaia.cat |
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| Spain |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | ICU Mortality | Posted | Count of Participants | Participants | up to 3 months |
|
|
|
| 0 |
| 243 |
| 0 |
| 243 |
| EG001 | SBT and Rest 60 Min Before Extubation | After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation. | 0 | 227 | 0 | 227 |
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