Noninvasive Ventilation in Acute Myocardial Infarction

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

acute myocardial infarction with Killip I classification, hemodynamic stability, between 24 and 72 hours post event;
agreement to participate in the study, according written informed consent;
45 to 80 years old age.

Exclusion criteria

unstable angina;
systolic blood pressure < 80 mmHg;
patients who presented ST elevation > 2 mm or with second-degree atrioventricular block;
presence of pacemaker.

Treatment and study plan

BILEVEL (Respironics)

Device

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 names: BIPAP

Continuos positive airway pressure (Respironics)

Device

CPAP was delivered by a ventilator (Respironics Inc, Murrysville, PA), applied via a facial mask, with expiratory positive airway pressure of 10 cmH2O.

Other names: CPAP

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Centro Universitário Augusto Motta

Other

Registry information

Official study title

Non Invasive Ventilation in Acute Myocardial Infarction

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Dec 2, 2011
Registry last updated: Dec 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed