Bilevel Positive Airway Pressure in Cardiac Surgery

January 5, 2022 updated by: Prof. Dr. Antônio Marcos Vargas da Silva

Effects of Bilevel Positive Airway Pressure in Postoperative Cardiac Surgery: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
        • Federal University of Santa Maria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Bilevel Positive Airway Pressure
Bilevel positive airway pressure twice per day during the hospital stay.
Other Names:
  • BiPAP
No Intervention: Control
Routine physical therapy will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peripheral Oxygen Saturation by pulse oximetry
Time Frame: up to 36 weeks
up to 36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Vital Signs
Time Frame: up to 36 weeks
up to 36 weeks
Length of stay
Time Frame: up to 36 weeks
up to 36 weeks
Postoperative complications
Time Frame: up to 36 weeks
up to 36 weeks
Six-minute walk test (6MWT)
Time Frame: up to 36 weeks
up to 36 weeks
Heart rate variability by a pulse frequency meter
Time Frame: up to 36 weeks
up to 36 weeks
Maximum inspiratory pressure by a digital pressure transducer (manovacuometry)
Time Frame: up to 36 weeks
up to 36 weeks
Maximum expiratory pressure by a digital pressure transducer (manovacuometry)
Time Frame: up to 36 weeks
up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Antônio Marcos Vargas da Silva

Investigators

  • Principal Investigator: Antônio M Vargas da Silva, PhD, Universidade Federal de Santa Maria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDAAA 801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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