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Bilevel Positive Airway Pressure in Cardiac Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02600182
Enrollment
36
Registered
2015-11-09
Start date
2015-12-31
Completion date
2019-05-31
Last updated
2022-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopathy, Surgery

Keywords

Thoracic surgery, Non-invasive ventilation, Physiotherapy

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.

Interventions

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

Sponsors

Prof. Dr. Antônio Marcos Vargas da Silva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Peripheral Oxygen Saturation by pulse oximetryup to 36 weeks

Secondary

MeasureTime frame
Length of stayup to 36 weeks
Postoperative complicationsup to 36 weeks
Six-minute walk test (6MWT)up to 36 weeks
Vital Signsup to 36 weeks
Maximum inspiratory pressure by a digital pressure transducer (manovacuometry)up to 36 weeks
Maximum expiratory pressure by a digital pressure transducer (manovacuometry)up to 36 weeks
Heart rate variability by a pulse frequency meterup to 36 weeks

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026