CPAP Versus Bi-level in Chronic Heart Failure

Summary

Introduction: Dyspnea and fatigue are the main clinical symptoms of heart failure and primarily responsible for exercise intolerance found in this syndrome. Now, It is known that the use of NIV in CPAP mode applied before exercise increases exercise tolerance in people with heart failure; however, it's not yet known if the bi-level mode is able to generate similar or even better results, due to pressure increase of the ventilatory support in this modality. Moreover, it is possible that there is influence between the pressure levels set in the NIV and the magnitude of its effect on the exercise in this population Objective: 1) test for differences between the acute effects of NIV on exercise tolerance in patients with HF, when applied CPAP or bi-level mode; and 2) check for discrepancies in the acute effects of Bi-level mode on the physical performance of these individuals, when applied at different pressure levels. Methodology: This is a controlled, randomized, double-blind and cross-over clinical trial, to be composed of 45 volunteers of both genders, aged between 30 and 80 years, with chronic heart failure, functional class II and III (New York Heart Association) in clinical stability. The experiment will be carried out on four different days, with a 48-hour interval between them, in which NIV will be used in the following modes: Bi-level with minimum parameters (EPAP = 6 cmH2O and IPAP = 12 cmH2O), Bi-level with maximum parameters EPAP = 8 cmH2O and IPAP = 14 cmH2O) and CPAP (6 cmH2O). Thus, all the volunteers will participate in the four TGC. During the tests, distance walking, perceived levels of fatigue and dyspnea, affective response, as well as other physiological variables will be analyzed. Statistical analysis, the ANOVA test for repeated measurements will be used, followed by the Bonferroni post-test, considering p-value less than or equal to 0.05 as statistically significant. Expected Results: This work is expected to improve the therapeutic management of HF patients, assisting in the implementation and improvement of methods to improve dyspnea and muscle fatigue, thus increasing tolerance to exercise.

Conditions

• Heart Failure

Interventions

DIAGNOSTIC_TEST

Shuttle walk test

A shuttle walk test was performed without any previous intervention.

DEVICE

Noninvasive ventilation (Bi-pap)

After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.

DEVICE

Noninvasive ventilation (CPAP)

After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.

Sponsors & Collaborators

• Patri-cia Angelica de Miranda Silva Nogueira

  lead OTHER

Principal Investigators

• Patrícia Nogueira, PhD · college professor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-19

Primary Completion

2015-11-23

Completion

2016-03-23