NCT02600182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 6, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

November 2, 2015

Last Update Submit

January 5, 2022

Conditions

CardiopathySurgery

Keywords

Thoracic surgeryNon-invasive ventilationPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Peripheral Oxygen Saturation by pulse oximetry

    up to 36 weeks

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Bilevel Positive Airway Pressure (BiPAP)

EXPERIMENTAL

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

Control

NO INTERVENTION

Routine physical therapy will be performed.

Interventions

Bilevel Positive Airway PressureDEVICE

Bilevel positive airway pressure twice per day during the hospital stay.

Also known as: BiPAP
Bilevel Positive Airway Pressure (BiPAP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patients in preoperative for coronary artery bypass or valve replacement.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, 97105-900, Brazil

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Antônio M Vargas da Silva, PhD

    Universidade Federal de Santa Maria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD in Physiology

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 9, 2015

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

May 1, 2019

Last Updated

January 6, 2022

Record last verified: 2022-01

Locations

BR(1)