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Noninvasive Ventilation in Acute Myocardial Infarction

Non Invasive Ventilation in Acute Myocardial Infarction

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01484795
Enrollment
10
Registered
2011-12-02
Start date
2011-01-31
Completion date
2011-11-30
Last updated
2011-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

noninvasive ventilation, autonomic nervous system

Brief summary

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.

Detailed description

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.

Interventions

DEVICEBILEVEL (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.

DEVICEContinuos 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.

Sponsors

Centro Universitário Augusto Motta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
evaluate HRV during NIV after acute myocardial infarctionsix monthsThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026