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Does Threshold IMT Influence Weaning?

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ClinicalTrials.gov Identifier: NCT00851617
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : March 6, 2009
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

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

Condition or disease Intervention/treatment Phase
Critical Care Mechanical Ventilation Device: Threshold® IMT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Is Threshold IMT Useful To Accelerate Weaning From Mechanical Ventilation?
Study Start Date : August 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : July 2007

Arm Intervention/treatment
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
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

No Intervention: Control Group
Patients were evaluated until weaning without interventions



Primary Outcome Measures :
  1. Weaning Acceleration [ Time Frame: Time weaning measured in hours ]

Secondary Outcome Measures :
  1. Strenght and ventilatory variables [ Time Frame: Time weaning measured in hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851617


Locations
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Brazil
Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Silvia Vieira, PhD Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre

Additional Information:
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Responsible Party: Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00851617     History of Changes
Other Study ID Numbers: 04-391
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: February 2009
Keywords provided by Hospital de Clinicas de Porto Alegre:
Mechanical ventilator weaning
Respiratory Muscle Training
Ventilator dependent