Clinical trial NCT00851617: Does Threshold IMT Influence Weaning?
Official title: Is Threshold IMT Useful To Accelerate Weaning From Mechanical Ventilation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Care
Mechanical Ventilation
Keywords: Mechanical ventilator weaning
Respiratory Muscle Training
Ventilator dependent
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2009-02-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Primary outcomes:
measure: Weaning Acceleration
timeFrame: Time weaning measured in hours
Secondary outcomes:
measure: Strenght and ventilatory variables
timeFrame: Time weaning measured in hours
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
name: Silvia Vieira, PhD
role: PRINCIPAL_INVESTIGATOR
References: