Bilevel Positive Airway Pressure in Cardiac Surgery

NCT02600182 — Not applicable, Completed, 36 participants, Prof. Dr. Antônio Marcos Vargas da Silva

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

Registry	NCT02600182
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	36 (Actual)
Sponsor	Prof. Dr. Antônio Marcos Vargas da Silva (Other)
Conditions	Cardiopathy, Surgery
Interventions	Bilevel Positive Airway Pressure (Device)
Dates	start 2015-12-01, primary completion 2016-09-01, completion 2019-05-01, first posted 2015-11-09, last updated 2022-01-06
Locations	1 site in Brazil

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Bilevel Positive Airway Pressure (BiPAP)	Experimental	Device: 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.
Control	No intervention		Routine physical therapy will be performed.

Bilevel Positive Airway Pressure (Device), also known as BiPAP: Bilevel positive airway pressure twice per day during the hospital stay.

+Outcome measures

Primary outcomes

Peripheral Oxygen Saturation by pulse oximetry [up to 36 weeks]

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Federal University of Santa Maria	Santa Maria, Rio Grande do Sul	Brazil

+Investigators

Antônio M Vargas da Silva, PhD, Principal investigator, Universidade Federal de Santa Maria