Does Threshold IMT Influence Weaning? - Full Text View

Sponsored by:	Hospital de Clinicas de Porto Alegre
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00851617

Purpose

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

Condition	Intervention
Critical Care Mechanical Ventilation	Device: Threshold® IMT

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment
Official Title:	Is Threshold IMT Useful To Accelerate Weaning From Mechanical Ventilation?

Resource links provided by NLM:

MedlinePlus related topics: Critical Care

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:

Weaning Acceleration [ Time Frame: Time weaning measured in hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Strenght and ventilatory variables [ Time Frame: Time weaning measured in hours ] [ Designated as safety issue: Yes ]

Enrollment:	92
Study Start Date:	August 2004
Study Completion Date:	July 2007
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851617

Locations

Brazil, RS
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

Principal Investigator:

Silvia Vieira, PhD

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

More Information

Additional Information:

Is the threshold useful in accelerating weaning from mechanical ventilation? This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Hospital de Clínicas de Porto Alegre ( Federal University of Rio Grande do Sul )
Study ID Numbers:	04-391
Study First Received:	February 9, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00851617 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:

Mechanical ventilator weaning
Respiratory Muscle Training
Ventilator dependent

ClinicalTrials.gov processed this record on September 10, 2009