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

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

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

Study Overview

• Status: Completed
• Conditions: Weaning Failure
• Intervention / Treatment: Procedure: REST

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 Type: Interventional
• Enrollment (Actual): 470
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain, 08221
      • 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

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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	Time Frame
ICU Mortality	up to 3 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Fernandez MM, Gonzalez-Castro A, Magret M, Bouza MT, Ibanez M, Garcia C, Balerdi B, Mas A, Arauzo V, Anon JM, Ruiz F, Ferreres J, Tomas R, Alabert M, Tizon 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: August 2, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Actual): July 1, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Weaning; Mechanical ventilation; Extubation failure
• Other Study ID Numbers: SBT Spain 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No