Clinical trial NCT01915563: Rest After Spontaneous Breathing Trial for Prevention of Post-extubation Failure
Official title: Phase 2 Study of 60-min Rest After Successful Spontaneous Breathing Trial Before Extubation as a Tool for Reduction Post-extubation Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weaning Failure
Keywords: Mechanical ventilation
Weaning
Extubation failure
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Patients With Extubation Failure
timeFrame: 48 hours
Secondary outcomes:
measure: ICU Mortality
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: 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
state: Barcelona
Study officials:
affiliation: Althaia Xarxa Assistencial Universitària de Manresa
name: Fernandez Rafael, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Mutua de Terrassa
name: Fernandez Maria del Mar, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.