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

NCT ID: NCT01915563

Last Updated: 2019-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-01-31

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.

Conditions

Weaning Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SBT and extubation

After a SBT patients will be extubated as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

SBT and rest 60 min before extubation

After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation

Group Type: EXPERIMENTAL

REST

Intervention Type: PROCEDURE

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

Interventions

REST

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Althaia Xarxa Assistencial Universitària de Manresa

OTHER

Sponsor Role: lead

Responsible Party

Rafael Fernandez

Head of Critical Care Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernandez Rafael, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Althaia Xarxa Assistencial Universitària de Manresa

Fernandez Maria del Mar, MD, PhD

Role: STUDY_DIRECTOR

Hospital Universitari Mutua de Terrassa

Locations

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

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 28936675 (View on PubMed)

Other Identifiers

SBT Spain 001

Identifier Type: -

Identifier Source: org_study_id