Does Threshold IMT Influence Weaning? - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 9, 2009

Last Updated Date

March 5, 2009

Start Date ^†

August 2004

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00851617 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Does Threshold IMT Influence Weaning?

Official Title ^†

Is Threshold IMT Useful To Accelerate Weaning From Mechanical Ventilation?

Brief Summary

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

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 Phase

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Open Label, Parallel Assignment

Condition ^†

Critical Care
Mechanical Ventilation

Intervention ^†

Device: Threshold® IMT

Study Arms / Comparison Groups

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
No Intervention: Patients were evaluated until weaning without interventions

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

July 2007

Primary Completion Date

March 2005 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Brazil

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00851617

Responsible Party

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

Secondary IDs ^††

Study Sponsor ^†

Hospital de Clinicas de Porto Alegre

Collaborators ^††

Investigators ^†

Principal Investigator:

Silvia Vieira, PhD

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

Information Provided By

Hospital de Clinicas de Porto Alegre

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.