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Completed

NCT Number: NCT00851617

Does Threshold IMT Influence Weaning?

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Threshold® IMT

Device

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

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

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

Is Threshold IMT Useful To Accelerate Weaning From Mechanical Ventilation?

Important dates

Study start
2004
Primary completion
2005
Study completion
2007
First posted
Feb 26, 2009
Registry last updated
Mar 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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