Bilevel Positive Airway Pressure in Cardiac Surgery

NCT ID: NCT02600182

Last Updated: 2022-01-06

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

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-05-31

Brief Summary

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The purpose of this study was to determine the effects of Bilevel Positive Airway Pressure (BiPAP) on variables clinics, cardiorespiratory and physical functional in patients undergoing cardiac surgery at the University Hospital of Santa Maria.

Detailed Description

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This randomized controlled trial aimed to evaluate the effects of Bilevel Positive Airway Pressure (BiPAP) in patients undergoing heart surgery of valve replacement and coronary artery bypass graft on the variables clinics, cardiorespiratory and physical functional.These individuals were randomized to compose the control group (GC) and the BiPAP group (GBiPAP). The routine physical therapy was performed in both groups and in the BiPAPG two daily sessions of 20 minutes were applied with positive expiratory pressure of 10cmH2O and inspiratory of 15cmH2O. To verify the effect of this intervention, before and after the protocol patients underwent the following evaluations: the 6-minute walk test (6MWT), the heart rate variability, the manovacuometry, and cirtometry in the axillary line, umbilical line and the xiphoid appendix.

Conditions

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Cardiopathy Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Bilevel Positive Airway Pressure (BiPAP)

The routine physical therapy will be performed in two groups (control and BiPAP). The BiPAP group will receive two daily sessions of 20 minutes, with positive expiratory pressure of 10cmH2O and inspiratory of 15cmH2O.

Group Type EXPERIMENTAL

Bilevel Positive Airway Pressure

Intervention Type DEVICE

Bilevel positive airway pressure twice per day during the hospital stay.

Control

Routine physical therapy will be performed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bilevel Positive Airway Pressure

Bilevel positive airway pressure twice per day during the hospital stay.

Intervention Type DEVICE

Other Intervention Names

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BiPAP

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patients in preoperative for coronary artery bypass or valve replacement.

Exclusion Criteria

* Inability to understand or sign a free and informed consent form
* Chronic obstructive pulmonary disease (COPD)
* Cerebrovascular disease
* Musculoskeletal disease
* Chronic infectious disease
* Unstable angina
* Treatment with steroids, hormones or chemotherapy for cancer
* Prolonged mechanical ventilation
* Unable of maintaining airway patency
* Severe hemodynamic instability
* Abdominal distension or vomiting.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Antônio Marcos Vargas da Silva

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Antônio Marcos Vargas da Silva

PhD in Physiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Antônio M Vargas da Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Santa Maria

Locations

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Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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FDAAA 801

Identifier Type: -

Identifier Source: org_study_id

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