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CompletedNCT00851617Updated Mar 6, 2009

Does Threshold IMT Influence Weaning?

An interventional study of Threshold® IMT in Critical Care and Mechanical Ventilation, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-03-06.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description
  • After at least 48 hours on CMV, the patients in PSV were randomized into two groups: control group and IMT group.
  • Before each protocol session, the cardiorespiratory variables such as f, HR, MAP and SpO2, as well as the support ventilatory variables such as PSV, PEEP, FiO2 and trigger sensitivity, were recorded.
  • After collecting the first records, the patients were placed in a 45º Fowler position, and variables MIP and MEP were collected with a unidirectional valve, as well as f, VE, Vt and f/Vt.
  • 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. Supplementary oxygen was added if necessary during the protocol. The training was cancelled in the presence of tachyarrhythmia, reduction of SpO2 under 85% and in the presence of fatigue signs or respiratory dysfunction. In this case, the patients returned to MV. All cardiorespiratory variables (f, HR, MAP and SpO2) were recorded again one minute after the end of the protocol. The same data were recorded in the control group before and after the protocol, but the patients were not trained with the threshold IMT device.
  • All patients were followed up until weaning. During this period, laboratory tests were recorded, such as: potassium, sodium and magnesium as well as arterial gasometry, calculating the partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio.
02

Conditions studied

  • Critical Care
  • Mechanical Ventilation

Keywords

  • Mechanical ventilator weaning
  • Respiratory Muscle Training
  • Ventilator dependent
03

In context

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    IMT Group

    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

  • No intervention
    Control Group

    Patients were evaluated until weaning without interventions

Interventions

  • DeviceThreshold® IMT

    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

06

What researchers measure

Primary outcomes

  1. Weaning Acceleration

    Time frame: Time weaning measured in hours

Secondary outcomes

  1. Strenght and ventilatory variables

    Time frame: Time weaning measured in hours

07

Study locations

1 site
  • Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
    Porto Alegre, RS 90035-903, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00851617
Lead sponsor
Hospital de Clinicas de Porto Alegre
First posted
Feb 26, 2009
Start date
Aug 2004
Primary completion
Mar 2005
Completion
Jul 2007
Last update
Mar 6, 2009

Study contacts

Silvia Vieira, PhD
principal investigator · Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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