Clinical trial NCT02600182: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopathy
Surgery
Keywords: Thoracic surgery
Non-invasive ventilation
Physiotherapy
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Peripheral Oxygen Saturation by pulse oximetry
timeFrame: up to 36 weeks
Secondary outcomes:
measure: Vital Signs
timeFrame: up to 36 weeks
measure: Length of stay
timeFrame: up to 36 weeks
measure: Postoperative complications
timeFrame: up to 36 weeks
measure: Six-minute walk test (6MWT)
timeFrame: up to 36 weeks
measure: Heart rate variability by a pulse frequency meter
timeFrame: up to 36 weeks
measure: Maximum inspiratory pressure by a digital pressure transducer (manovacuometry)
timeFrame: up to 36 weeks
measure: Maximum expiratory pressure by a digital pressure transducer (manovacuometry)
timeFrame: up to 36 weeks
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Federal University of Santa Maria
state: Rio Grande Do Sul
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Antônio M Vargas da Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References: