NCT01915563

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

July 1, 2019

Completed
Last Updated

July 1, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

July 31, 2013

Results QC Date

January 9, 2019

Last Update Submit

April 5, 2019

Conditions

Weaning Failure

Keywords

Mechanical ventilationWeaningExtubation failure

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Extubation Failure

    Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation

    48 hours

Secondary Outcomes (1)

  • ICU Mortality

    up to 3 months

Study Arms (2)

SBT and extubation

NO INTERVENTION

After a SBT patients will be extubated as usual

SBT and rest 60 min before extubation

EXPERIMENTAL

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

Procedure: REST

Interventions

RESTPROCEDURE

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

SBT and rest 60 min before extubation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients ventilated for more than 12h and ready to perform a SBT

You may not qualify if:

  • patients under 18 years old,
  • tracheostomy,
  • excessive bronchial secretions,
  • agitation,
  • hypercapnia during SBT and not resuscitation orders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, 08221, Spain

Location

Related Publications (1)

  • 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.

    PMID: 28936675DERIVED

Results Point of Contact

Title
Dr Rafael Fernandez
Organization
Althaia Xarxa Assistencial Universitaria de Manresa
rfernandezf@althaia.cat
34.8732550

Study Officials

  • Fernandez Rafael, MD, PhD

    Althaia Xarxa Assistencial Universitària de Manresa

    PRINCIPAL INVESTIGATOR

  • Fernandez Maria del Mar, MD, PhD

    Hospital Universitari Mutua de Terrassa

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Critical Care Department

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 5, 2013

Study Start

September 1, 2013

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

July 1, 2019

Results First Posted

July 1, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)