Bilevel Positive Airway Pressure in Cardiac Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600182
• Other study ID #: FDAAA 801
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: May 2019

Study information

• Verified date: January 2022
• Source: Universidade Federal de Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2019
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiopathy
• Heart Diseases
• Surgery

Intervention

Device:
• Bilevel Positive Airway Pressure
Bilevel positive airway pressure twice per day during the hospital stay.

Locations

Country	Name	City	State
Brazil	Federal University of Santa Maria	Santa Maria	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Antônio Marcos Vargas da Silva

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral Oxygen Saturation by pulse oximetry		up to 36 weeks
Secondary	Vital Signs		up to 36 weeks
Secondary	Length of stay		up to 36 weeks
Secondary	Postoperative complications		up to 36 weeks
Secondary	Six-minute walk test (6MWT)		up to 36 weeks
Secondary	Heart rate variability by a pulse frequency meter		up to 36 weeks
Secondary	Maximum inspiratory pressure by a digital pressure transducer (manovacuometry)		up to 36 weeks
Secondary	Maximum expiratory pressure by a digital pressure transducer (manovacuometry)		up to 36 weeks