Bilevel Positive Airway Pressure in Cardiac Surgery

Not Applicable

Completed

• Conditions: Surgery; Cardiopathy
• Interventions: Device: Bilevel Positive Airway Pressure

• Registration Number: NCT02600182
• Lead Sponsor: Prof. Dr. Antônio Marcos Vargas da Silva

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.

Study Timeline

• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-09
• Study Start: 2015-12
• Primary Completion: 2016-09
• Study Completion: 2019-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilevel Positive Airway Pressure (BiPAP)	Bilevel Positive Airway Pressure	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.

Primary Outcome Measures

Name	Time	Method
Peripheral Oxygen Saturation by pulse oximetry	up to 36 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Federal University of Santa Maria; 🇧🇷 Santa Maria, Rio Grande Do Sul, Brazil