Rest After Spontaneous Breathing Trial for Prevention of Post-extubation Failure
- Conditions
- Weaning Failure
- Interventions
- Procedure: REST
- Registration Number
- NCT01915563
- Lead Sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Brief Summary
To evaluate if a rest period before extubation after a successful SBT trial could reduce the extubation failure rate.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 470
- patients ventilated for more than 12h and ready to perform a SBT
- patients under 18 years old,
- tracheostomy,
- excessive bronchial secretions,
- agitation,
- hypercapnia during SBT and not resuscitation orders.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SBT and rest 60 min before extubation REST After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation
- Primary Outcome Measures
Name Time Method Number of Patients With Extubation Failure 48 hours Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation
- Secondary Outcome Measures
Name Time Method ICU Mortality up to 3 months
Trial Locations
- Locations (1)
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, Spain