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Bilevel Positive Airway Pressure in Cardiac Surgery

Sponsor
Prof. Dr. Antônio Marcos Vargas da Silva (Other)
Overall Status
Completed
CT.gov ID
NCT02600182
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
41
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Bilevel Positive Airway Pressure
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Bilevel Positive Airway Pressure in Postoperative Cardiac Surgery: A Randomized Clinical Trial
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bilevel Positive Airway Pressure (BiPAP)

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
Bilevel positive airway pressure twice per day during the hospital stay.
Other Names:
  • BiPAP

    		•
    No Intervention: Control

    Routine physical therapy will be performed.

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Vital Signs [up to 36 weeks]

    2. Length of stay [up to 36 weeks]

    3. Postoperative complications [up to 36 weeks]

    4. Six-minute walk test (6MWT) [up to 36 weeks]

    5. Heart rate variability by a pulse frequency meter [up to 36 weeks]

    6. Maximum inspiratory pressure by a digital pressure transducer (manovacuometry) [up to 36 weeks]

    7. Maximum expiratory pressure by a digital pressure transducer (manovacuometry) [up to 36 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Federal University of Santa Maria Santa Maria Rio Grande Do Sul Brazil 97105-900

    Sponsors and Collaborators

    • Prof. Dr. Antônio Marcos Vargas da Silva

    Investigators

    • Principal Investigator: Antônio M Vargas da Silva, PhD, Universidade Federal de Santa Maria

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Antônio Marcos Vargas da Silva, PhD in Physiology, Universidade Federal de Santa Maria
    ClinicalTrials.gov Identifier:
    NCT02600182
    Other Study ID Numbers:
    • FDAAA 801
    First Posted:
    Nov 9, 2015
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Prof. Dr. Antônio Marcos Vargas da Silva, PhD in Physiology, Universidade Federal de Santa Maria
    Thoracic surgery
    Non-invasive ventilation
    Physiotherapy
    Additional relevant MeSH terms:
    Heart Diseases

    Study Results

    No Results Posted as of Jan 6, 2022