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Clinical Trials/NCT01416519
NCT01416519
Completed
Not Applicable

Incentive Spirometry Decreases Respiratory Complications After Myocardial Revascularization

Santa Casa de Votuporanga1 site in 1 country200 target enrollmentSeptember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonia
Sponsor
Santa Casa de Votuporanga
Enrollment
200
Locations
1
Primary Endpoint
Pulmonary complications
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (Voldyne ®) and another with the application of NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main focus of the study is to determine the incidence of pulmonary complications in each technique.

Detailed Description

Coronary artery bypass graft (CABG) can prolong and improve the quality of life of patients with ischemic coronary syndrome but with the advancement of medical intervention to eligible patients for this procedure are those with more comorbidities where conservation and palliative therapies have been tried without success. Patients undergoing CABG often develop pulmonary complications such as atelectasis, restrictive ventilatory defect, decreased lung compliance, increased shunt and changes in gas exchange leading to probable hypoxemia. In an attempt to reduce the harmful effects and pulmonary complications arising from surgical procedures is instituted extensive physiotherapy program that tracks and monitors such patients from the preoperative to the postoperative immediate transfer to the ward and hospital discharge. The objective of this study is to assess whether there is a difference between a care protocol with the use of incentive spirometry (Voldyne ®) and another with the application of NIV (non invasive ventilation with single-level pressure) as a form of therapy. The main focus of the study is to determine the incidence of pulmonary complications in each technique.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
January 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Santa Casa de Votuporanga
Responsible Party
Principal Investigator
Principal Investigator

Marcos Aurelio Barboza de Oliveira

M.D.

Santa Casa de Votuporanga

Eligibility Criteria

Inclusion Criteria

  • Patients with indication for elective coronary artery bypass surgery who agreed to participate and signed the informed consent.

Exclusion Criteria

  • patients with hemodynamic instability during the physiotherapy care
  • those who fail to complete all visits to the proposed protocol (whatever the reason)
  • extubation after 12 hours of ICU admission
  • major intraoperative hemorrhage
  • major bleeding in ICU requiring return to the operating room
  • cardiopulmonary arrest
  • contraindication to positive pressure (undrained pneumothorax, bronchopleural fistula, hemoptysis, vomiting) or intolerance to the method

Outcomes

Primary Outcomes

Pulmonary complications

Time Frame: 72 hours

Occurrence of pulmonary complications such as pneumonia, atelectasis or pleural effusion diagnosed with chest X-rays by ICU doctor.

Secondary Outcomes

  • Exams(72 hours)

Study Sites (1)

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