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Clinical Trials/NCT01915563
NCT01915563CompletedNot Applicable

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

Althaia Xarxa Assistencial Universitària de Manresa2 sites in 1 country470 target enrollmentStarted: September 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
470
Locations
2
Primary Endpoint
Number of Patients With Extubation Failure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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

Intervention: REST (Procedure)

Outcomes

Primary Outcomes

Number of Patients With Extubation Failure

Time Frame: 48 hours

Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation

Secondary Outcomes

  • ICU Mortality(up to 3 months)

Investigators

Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rafael Fernandez

Head of Critical Care Department

Althaia Xarxa Assistencial Universitària de Manresa

Study Sites (2)

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