Does Threshold IMT Influence Weaning?

March 5, 2009 updated by: Hospital de Clinicas de Porto Alegre

Is Threshold IMT Useful To Accelerate Weaning From Mechanical Ventilation?

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weaning Acceleration
Time Frame: Time weaning measured in hours
Time weaning measured in hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Strenght and ventilatory variables
Time Frame: Time weaning measured in hours
Time weaning measured in hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Silvia Vieira, PhD, Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 25, 2009

First Posted (Estimate)

February 26, 2009

Study Record Updates

Last Update Posted (Estimate)

March 6, 2009

Last Update Submitted That Met QC Criteria

March 5, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 04-391

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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