NCT01867853

Brief Summary

To evaluate the performance of volume responsiveness in predicting the outcome of mechanical ventilation weaning in critically ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

May 6, 2013

Last Update Submit

June 3, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • changes of cardiac index

    30 minutes

Study Arms (2)

successful weaning

the SUCCESS of SBT or not need for reintubation or noninvasive ventilation within 48 h following extubation

Device: PLR

failed weaning

the failure of SBT or the need for reintubation or noninvasive ventilation within 48 h following extubation

Device: PLR

Interventions

PLRDEVICE

passive leg raising test was done before and at the end of SBT

Also known as: passive leg raising
failed weaningsuccessful weaning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients were mechanically ventilated and ready to undergo a spontaneous breathing trial (SBT) with a T-piece

You may qualify if:

  • mechanical ventilation

You may not qualify if:

  • pregnancy or breast-feeding
  • tracheostomy at baseline
  • myasthenia gravis or acute polyradiculoneuropathy
  • end-stage chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda hospital

Nanjing, Jiangsu, 210009, China

Location

Related Publications (6)

  • MacIntyre N. Discontinuing mechanical ventilatory support. Chest. 2007 Sep;132(3):1049-56. doi: 10.1378/chest.06-2862.

  • Eskandar N, Apostolakos MJ. Weaning from mechanical ventilation. Crit Care Clin. 2007 Apr;23(2):263-74, x. doi: 10.1016/j.ccc.2006.12.002.

  • MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.

  • Monnet X, Teboul JL, Richard C. Cardiopulmonary interactions in patients with heart failure. Curr Opin Crit Care. 2007 Feb;13(1):6-11. doi: 10.1097/MCC.0b013e328013c865.

  • Teboul JL, Monnet X. Detecting volume responsiveness and unresponsiveness in intensive care unit patients: two different problems, only one solution. Crit Care. 2009;13(4):175. doi: 10.1186/cc7979. Epub 2009 Aug 10.

  • Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.

Study Officials

  • Zhimin DOU

    Southeast University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 6, 2013

First Posted

June 4, 2013

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations