Rest After Spontaneous Breathing Trial for Prevention of Post-extubation Failure

Study Overview
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Brief Summary
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To evaluate if a rest period before extubation after a successful SBT trial could reduce the extubation failure rate.

Detailed Description
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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.

Official Title
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Phase 2 Study of 60-min Rest After Successful Spontaneous Breathing Trial Before Extubation as a Tool for Reduction Post-extubation Failure.

Conditions
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Weaning Failure

Intervention / Treatment
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* Procedure: REST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients ventilated for more than 12h and ready to perform a SBT Exclusion Criteria: patients under 18 years old, tracheostomy, excessive bronchial secretions, agitation, hypercapnia during SBT and not resuscitation orders.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: SBT and extubation<br>After a SBT patients will be extubated as usual | |
| Experimental: SBT and rest 60 min before extubation<br>After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation | Procedure: REST<br>* After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Mortality |  | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Weaning, Extubation failure