NCT02620358

Brief Summary

This study compares two opposite strategies of weaning from Mechanical Ventilation. One of them is Low Pressure Support Ventilation during 30 minutes and the other is T-Tube for 2 hours. The aim of the study is to know witch one has a higher successful extubation rate.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

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

November 20, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 11, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2017

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

November 20, 2015

Last Update Submit

March 30, 2017

Conditions

Weaning Failure

Keywords

Mechanical VentilationWeaning

Outcome Measures

Primary Outcomes (1)

  • Succesful extubation rate

    Rate of succesful extubation after one of the weaning strategy

    72 hours

Secondary Outcomes (4)

  • ICU Length of Stay

    3 month

  • Hospital Length of Stay

    3 month

  • Mortality

    3 month

  • Reintubation rate

    72 hours

Study Arms (2)

High Work of Breathing

EXPERIMENTAL

If patient has weaning criteria, a Spontaneous Breathing Trial (SBT) with T Tube for 2 hours will be done. The patient will be extubated after the SBT if he has no criteria of SBT failure.

Other: T Tube for 120 minuts

Low Work of Breathing

EXPERIMENTAL

If patient has weaning criteria a Spontaneous Breathing Trial (SBT) with Pressure Support Ventilation of 8 cmH2O for 30 minutes will be done. The patient will be extubated after the SBT if he has no criteria of SBT failure.

Other: Pressure Support Ventilation of 8 cmH2O for 30 minutes

Interventions

T Tube for 120 minutsOTHER

Spontaneous Breathing Trial using T Tube for 120 minutes.

High Work of Breathing
Pressure Support Ventilation of 8 cmH2O for 30 minutesOTHER

Spontaneous Breathing Trial using Pressure Support Ventilation of 8 cmH2O for 30 minutes

Low Work of Breathing

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More tan 18 years old
  • More tan 24 hour of Mechanical Ventilation ready for weaning

You may not qualify if:

  • Tracheostomy
  • Non reintubation orders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N. Protocol-directed weaning from mechanical ventilation: clinical outcome in patients randomized for a 30-min or 120-min trial with pressure support ventilation. Intensive Care Med. 2002 Aug;28(8):1058-63. doi: 10.1007/s00134-002-1353-z. Epub 2002 Jul 13.

    PMID: 12185425BACKGROUND

  • Esteban A, Anzueto A, Alia I, Gordo F, Apezteguia C, Palizas F, Cide D, Goldwaser R, Soto L, Bugedo G, Rodrigo C, Pimentel J, Raimondi G, Tobin MJ. How is mechanical ventilation employed in the intensive care unit? An international utilization review. Am J Respir Crit Care Med. 2000 May;161(5):1450-8. doi: 10.1164/ajrccm.161.5.9902018.

    PMID: 10806138BACKGROUND

  • Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.

    PMID: 7921460RESULT

  • Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.

    PMID: 9927366RESULT

  • Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.

    PMID: 9279224RESULT

  • Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.

    PMID: 11790214RESULT

  • Subira C, Hernandez G, Vazquez A, Rodriguez-Garcia R, Gonzalez-Castro A, Garcia C, Rubio O, Ventura L, Lopez A, de la Torre MC, Keough E, Arauzo V, Hermosa C, Sanchez C, Tizon A, Tenza E, Laborda C, Cabanes S, Lacueva V, Del Mar Fernandez M, Arnau A, Fernandez R. Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jun 11;321(22):2175-2182. doi: 10.1001/jama.2019.7234.

    PMID: 31184740DERIVED

Study Officials

  • Fernandez Rafael, MD

    Althaia Xarxa Assistencial Manresa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

November 20, 2015

First Posted

December 3, 2015

Study Start

January 11, 2016

Primary Completion

March 28, 2017

Study Completion

March 28, 2017

Last Updated

March 31, 2017

Record last verified: 2017-03