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Completed

NCT Number: NCT02600182

Bilevel Positive Airway Pressure in Cardiac Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bilevel Positive Airway Pressure

Device

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

Other names: BiPAP

Primary outcomes

  1. Peripheral Oxygen Saturation by pulse oximetry

    Time frame: up to 36 weeks

Secondary outcomes

  1. Vital Signs

    Time frame: up to 36 weeks

  2. Length of stay

    Time frame: up to 36 weeks

  3. Postoperative complications

    Time frame: up to 36 weeks

  4. Six-minute walk test (6MWT)

    Time frame: up to 36 weeks

  5. Heart rate variability by a pulse frequency meter

    Time frame: up to 36 weeks

  6. Maximum inspiratory pressure by a digital pressure transducer (manovacuometry)

    Time frame: up to 36 weeks

  7. Maximum expiratory pressure by a digital pressure transducer (manovacuometry)

    Time frame: up to 36 weeks

Sponsors and collaborators

Lead sponsor

Prof. Dr. Antônio Marcos Vargas da Silva

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Nov 9, 2015
Registry last updated
Jan 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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