NCT00851617

Brief Summary

Patients under threshold IMT show better conditions to weaning from mechanical ventilation than the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2004

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
Last Updated

March 6, 2009

Status Verified

February 1, 2009

Enrollment Period

7 months

First QC Date

February 9, 2009

Last Update Submit

March 5, 2009

Conditions

Critical CareMechanical Ventilation

Keywords

Mechanical ventilator weaningRespiratory Muscle TrainingVentilator dependent

Outcome Measures

Primary Outcomes (1)

  • Weaning Acceleration

    Time weaning measured in hours

Secondary Outcomes (1)

  • Strenght and ventilatory variables

    Time weaning measured in hours

Study Arms (2)

IMT Group

EXPERIMENTAL

The IMT group was trained using the threshold IMT device with a 40% MIP load. Each training session consisted of 5 sets with 10 breaths, twice a day

Device: Threshold® IMT

Control Group

NO INTERVENTION

Patients were evaluated until weaning without interventions

Interventions

Threshold® IMTDEVICE

The IMT group was trained using the threshold IMT device with a 40% MIP load. Each training session consisted of 5 sets with 10 breaths, twice a day

IMT Group

Eligibility Criteria

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

You may qualify if:

  • The patients included in this study were under MV for more than 48 hours of CMV and ventilated with pressure support ventilation (PSV) between 12 and 15 cmH2O, with positive end-expiratory pressure (PEEP) between 5 and 7 cmH2O, hemodynamically stable without vasoactive drugs (dopamine, dobutamine or norepinephrine) or sedative agents.

You may not qualify if:

  • This study excluded hypotensive patients (systolic blood pressure \< 100 mmHg or mean blood pressure \< 70 mmHg), severe intracranial disease and sensory reduction, barotrauma, tracheotomy, neuromuscular disease and the use of vasoactive drugs or sedatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Study Officials

  • Silvia Vieira, PhD

    Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 26, 2009

Study Start

August 1, 2004

Primary Completion

March 1, 2005

Study Completion

July 1, 2007

Last Updated

March 6, 2009

Record last verified: 2009-02

Locations

BR(1)