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

• ClinicalTrials.gov Identifier: NCT01915563
• Recruitment Status: Completed
• First Posted: August 5, 2013
• Results First Posted: July 1, 2019
• Last Update Posted: July 1, 2019
• Sponsor: Althaia Xarxa Assistencial Universitària de Manresa
• Information provided by (Responsible Party): Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Weaning Failure	Procedure: REST	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 470 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Phase 2 Study of 60-min Rest After Successful Spontaneous Breathing Trial Before Extubation as a Tool for Reduction Post-extubation Failure.
• Actual Study Start Date: September 2013
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: January 2015

Arms and Interventions

Arm	Intervention/treatment
No Intervention: SBT and extubation; After a SBT patients will be extubated as usual
Experimental: SBT and rest 60 min before extubation; After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation	Procedure: REST; After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation.

Outcome Measures

Primary Outcome Measures :

1. Number of Patients With Extubation Failure [ Time Frame: 48 hours ]
   Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation

Secondary Outcome Measures :

1. ICU Mortality [ Time Frame: up to 3 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

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, Spain, 08221

Sponsors and Collaborators

Althaia Xarxa Assistencial Universitària de Manresa

Investigators

• Principal Investigator: Fernandez Rafael, MD, PhD; Althaia Xarxa Assistencial Universitària de Manresa
• Study Director: Fernandez Maria del Mar, MD, PhD; Hospital Universitari Mutua de Terrassa

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fernandez MM, González-Castro A, Magret M, Bouza MT, Ibañez M, García C, Balerdi B, Mas A, Arauzo V, Añón JM, Ruiz F, Ferreres J, Tomás R, Alabert M, Tizón 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.

• Responsible Party: Rafael Fernandez, Head of Critical Care Department, Althaia Xarxa Assistencial Universitària de Manresa
• ClinicalTrials.gov Identifier: NCT01915563
• Other Study ID Numbers: SBT Spain 001
• First Posted: August 5, 2013
• Results First Posted: July 1, 2019
• Last Update Posted: July 1, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa:

Mechanical ventilation; Weaning; Extubation failure

Additional relevant MeSH terms:

Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes