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

Weaning Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915563
• Other study ID #: SBT Spain 001
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: April 2019
• Source: Althaia Xarxa Assistencial Universitària de Manresa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Weaning Failure

Intervention

Procedure:
• REST
After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation.

Locations

Country	Name	City	State
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Althaia Xarxa Assistencial Universitària de Manresa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Extubation Failure	Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation	48 hours
Secondary	ICU Mortality		up to 3 months