Bilevel Positive Airway Pressure in Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiopathy, Surgery

Intervention / Treatment
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* Device: Bilevel Positive Airway Pressure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilevel Positive Airway Pressure (BiPAP)<br>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. | Device: Bilevel Positive Airway Pressure<br>* Bilevel positive airway pressure twice per day during the hospital stay.<br>* Other names: BiPAP;|
| No Intervention: Control<br>Routine physical therapy will be performed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Oxygen Saturation by pulse oximetry |  | up to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital Signs |  | up to 36 weeks | 
| Length of stay |  | up to 36 weeks | 
| Postoperative complications |  | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic surgery, Non-invasive ventilation, Physiotherapy