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Bilevel Positive Airway Pressure in Cardiac Surgery

Primary Purpose

Cardiopathy, Surgery

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bilevel Positive Airway Pressure
Sponsored by
Prof. Dr. Antônio Marcos Vargas da Silva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiopathy focused on measuring Thoracic surgery, Non-invasive ventilation, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of Santa Maria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bilevel Positive Airway Pressure (BiPAP)

Control

Arm Description

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.

Routine physical therapy will be performed.

Outcomes

Primary Outcome Measures

Peripheral Oxygen Saturation by pulse oximetry

Secondary Outcome Measures

Vital Signs
Length of stay
Postoperative complications
Six-minute walk test (6MWT)
Heart rate variability by a pulse frequency meter
Maximum inspiratory pressure by a digital pressure transducer (manovacuometry)
Maximum expiratory pressure by a digital pressure transducer (manovacuometry)

Full Information

First Posted
November 2, 2015
Last Updated
January 5, 2022
Sponsor
Prof. Dr. Antônio Marcos Vargas da Silva
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1. Study Identification

Unique Protocol Identification Number
NCT02600182
Brief Title
Bilevel Positive Airway Pressure in Cardiac Surgery
Official Title
Effects of Bilevel Positive Airway Pressure in Postoperative Cardiac Surgery: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Antônio Marcos Vargas da Silva

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopathy, Surgery
Keywords
Thoracic surgery, Non-invasive ventilation, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilevel Positive Airway Pressure (BiPAP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine physical therapy will be performed.
Intervention Type
Device
Intervention Name(s)
Bilevel Positive Airway Pressure
Other Intervention Name(s)
BiPAP
Intervention Description
Bilevel positive airway pressure twice per day during the hospital stay.
Primary Outcome Measure Information:
Title
Peripheral Oxygen Saturation by pulse oximetry
Time Frame
up to 36 weeks
Secondary Outcome Measure Information:
Title
Vital Signs
Time Frame
up to 36 weeks
Title
Length of stay
Time Frame
up to 36 weeks
Title
Postoperative complications
Time Frame
up to 36 weeks
Title
Six-minute walk test (6MWT)
Time Frame
up to 36 weeks
Title
Heart rate variability by a pulse frequency meter
Time Frame
up to 36 weeks
Title
Maximum inspiratory pressure by a digital pressure transducer (manovacuometry)
Time Frame
up to 36 weeks
Title
Maximum expiratory pressure by a digital pressure transducer (manovacuometry)
Time Frame
up to 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antônio M Vargas da Silva, PhD
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Santa Maria
City
Santa Maria
State/Province
Rio Grande Do Sul
ZIP/Postal Code
97105-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Bilevel Positive Airway Pressure in Cardiac Surgery

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