Weaning Failure Clinical Trial
Official title:
Inspiratory Muscle Training in Difficult to Wean Patients: a Randomised Controlled Trial
Verified date | June 2024 |
Source | KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prolonged mechanical ventilation secondary to weaning failure demands a significant amount of intensive care unit (ICU) resources, thus increasing the economic burden of public healthcare costs. One of the proposed mechanisms accounting for weaning failure is the concept that excessive work of breathing for weak respiratory muscles during the liberation from mechanical ventilation compromises cerebral blood flow, thereby predisposing the brain to dysfunction. Restriction in brain perfusion could have an adverse impact on the function of the respiratory muscles by impairing the output of the respiratory centre thus promoting respiratory muscle fatigue, leading to weaning failure. Inspiratory muscle training (IMT) has been shown to improve the functional capacity of the inspiratory muscles in patients with respiratory muscle weakness whilst has been recently proposed as a possible additional component of weaning strategies. Therefore, this project aims to identify both a mechanism that might be linked to prolong ICU length of stay and that at the same time might be amenable to treatment.
Status | Completed |
Enrollment | 90 |
Est. completion date | October 1, 2023 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Difficult and prolonged weaning patients - Simple weaning patients - Adequate oxygenation - Febrile temperature < 38ºC - Hemodynamic stability - Stable blood pressure - No or minimal pressors - No myocardial ischemia - Adequate hemoglobin and mentation - Resolution of disease acute phase - Able to follow simple verbal commands related to IMT - Mechanically ventilated via a tracheostomy or endotracheal tube Exclusion Criteria: - Pre-existing neuromuscular disease - Agitation - Hemodynamically instable (arrhythmia, decompensated heart failure, coronary insufficiency) - Hemoptysis - Diaphoresis - Spinal cord injury above T8 - Use of any type of home MV support prior to hospitalization - Skeletal pathology that impairs chest wall movements - Poor general prognosis or fatal outcome |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Leuven | Leuven | |
Netherlands | Universitair Medisch Centra Amsterdam | Amsterdam | North Holland |
Lead Sponsor | Collaborator |
---|---|
KU Leuven |
Belgium, Netherlands,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weaning Success | Successful separation attempt without reintubation or reconnection to the MV | Maximal duration of IMT treatment: 28 days | |
Primary | Inspiratory muscles and cerebral cortex blood flow index ([BFI] measured in nanomoles per second, [minimum and maximum scores 0 to 100 nanomoles per second]) | Measured with Near Infrared Spectroscopy | Maximal duration of IMT treatment: 28 days | |
Primary | Inspiratory muscles and cerebral cortex fractional oxygen availability (StiO2% measured as a percentage [minimum and maximum scores 0 to 100 %]) | Measured with Near Infrared Spectroscopy | Maximal duration of IMT treatment: 28 days | |
Secondary | Length of stay in the ICU | (days) | Maximal duration of IMT treatment: 28 days | |
Secondary | Duration of mechanical ventilation | days since patient was connected to mechanical ventilator | Maximal duration of IMT treatment: 28 days | |
Secondary | rapid shallow breathing index after 2 hours of successful SBT | (Breaths/minute/liters) | Maximal duration of IMT treatment: 28 days | |
Secondary | Vital Capacity | (L) | Maximal duration of IMT treatment: 28 days | |
Secondary | MIP | (cmH2O) | Maximal duration of IMT treatment: 28 days | |
Secondary | ventilator-free days | days free from the mechanical ventilation | Maximal duration of IMT treatment: 28 days |
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