Clinical trial NCT01416519: Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation
Official title: Incentive Spirometry Decreases Respiratory Complications After Myocardial Revascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Pleural Effusion
Atelectasis
Keywords: Continuous Positive Airway Pressure
Cough
Oxygen Inhalation Therapy
Lead sponsor: Santa Casa de Votuporanga
Sponsor class: OTHER
First posted: 2011-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Pulmonary complications
timeFrame: 72 hours
Secondary outcomes:
measure: Exams
timeFrame: 72 hours
Other outcomes:
Locations:
city: Votuporanga
country: Brazil
facility: Santa Casa Votuporanga
state: São Paulo
Study officials:
affiliation: Santa Casa Votuporanga
name: Marcos Aurelio Barboza de Oliveira, MD
role: PRINCIPAL_INVESTIGATOR
References: