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Clinical Trials/NCT02600182
NCT02600182
Completed
Not Applicable

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

Prof. Dr. Antônio Marcos Vargas da Silva1 site in 1 country36 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiopathy
Sponsor
Prof. Dr. Antônio Marcos Vargas da Silva
Enrollment
36
Locations
1
Primary Endpoint
Peripheral Oxygen Saturation by pulse oximetry
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
May 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Prof. Dr. Antônio Marcos Vargas da Silva
Responsible Party
Sponsor Investigator
Principal Investigator

Prof. Dr. Antônio Marcos Vargas da Silva

PhD in Physiology

Universidade Federal de Santa Maria

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

Outcomes

Primary Outcomes

Peripheral Oxygen Saturation by pulse oximetry

Time Frame: up to 36 weeks

Secondary Outcomes

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

Study Sites (1)

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