Noninvasive Ventilation in Acute Myocardial Infarction
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|ClinicalTrials.gov Identifier: NCT01484795|
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : December 2, 2011
Cardiovascular diseases, especially acute myocardial infarction (AMI), represent the major cause of mortality and morbidity in the world. The myocardial ischemia is often the precipitating cause of pulmonary edema and noninvasive ventilation (NIV) with positive pressure has been used as a therapeutic modality.
Objective: to evaluate the effects of NIV on heart rate variability (HRV) and on ventilatory and hemodynamic variables in patients with myocardial infarction.
Materials and methods: ten patients with acute myocardial infarction, with Killip I classification, will use continuous positive airway pressure (CPAP) and Bilevel ventilation during 30 minutes, according randomization. Then ventilatory and hemodynamic variables will be registered and electrocardiogram signals will be recorded for posterior analyses of HRV. Data will be collected before, during and after positive pressure ventilation.
Statistical Analysis: Data will be compared using One Way Anova Repeated Measures, followed by Tukey test.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Device: BILEVEL (Respironics) Device: Continuos positive airway pressure (Respironics)||Phase 1|
The patients will be recruited in Bonsucesso Federal Hospital with diagnosis of myocardial infarction, confirmed by electrocardiogram and cardiac enzymes, between 24 and 72 hours after the event.
Participation in the study protocol will be done according to eligibility criteria:
The study will be a randomized and crossover clinical trial for evaluation and comparison of heart rate variability and ventilatory and hemodynamics variables during ventilation with CPAP and Bilevel.
CPAP will be applied via a facial mask, with expiratory positive airway pressure of 10 cmH2O. Bilevel will be applied via facial mask, with inspiratory positive pressure (IPAP) of 20 cmH2O and expiratory positive airway pressure (EPAP) of 10 cmH2O.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non Invasive Ventilation in Acute Myocardial Infarction|
|Study Start Date :||January 2011|
|Primary Completion Date :||June 2011|
|Study Completion Date :||November 2011|
|Experimental: Continuous positive airway pressure||
Device: Continuos positive airway pressure (Respironics)
CPAP was delivered by a ventilator (Respironics Inc, Murrysville, PA), applied via a facial mask, with expiratory positive airway pressure of 10 cmH2O.
Other Name: CPAP
Device: BILEVEL (Respironics)
Bilevel was delivered by a Bipap® ventilator (Respironics Inc, Murrysville, PA), applied via facial mask, with inspiratory positive pressure (IPAP) of 20 cmH2O and expiratory positive airway pressure (EPAP) of 10 cmH2O.
Other Name: BIPAP
- evaluate HRV during NIV after acute myocardial infarction [ Time Frame: six months ]The study consisted of randomized and crossover clinical trial for evaluation and comparison of heart rate variability and ventilatory and hemodynamics variables during ventilation with CPAP and Bilevel.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484795
|Principal Investigator:||Cristina M Dias, PT - PhD||Centro Universitário Augusto Motta|