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Noninvasive Ventilation in Acute Myocardial Infarction

NCT ID: NCT01484795

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Acute Myocardial Infarction

Keywords

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noninvasive ventilation autonomic nervous system

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Continuous positive airway pressure

Group Type EXPERIMENTAL

Continuos positive airway pressure (Respironics)

Intervention Type DEVICE

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

BILEVEL

Group Type EXPERIMENTAL

BILEVEL (Respironics)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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BIPAP CPAP

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Universitário Augusto Motta

OTHER

Sponsor Role lead

Responsible Party

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Cristina Marcia Dias

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristina M Dias, PT - PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Universitário Augusto Motta

Other Identifiers

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Cristina Dias

Identifier Type: -

Identifier Source: org_study_id