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Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation

Not Applicable
Completed
Conditions
Pneumonia
Pleural Effusion
Atelectasis
Interventions
Procedure: Continuous Positive Airway Pressure (CPAP) facial mask
Procedure: Assisted deep inspiration technique
Registration Number
NCT01416519
Lead Sponsor
Santa Casa de Votuporanga
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 1Continuous Positive Airway Pressure (CPAP) facial maskAfter extubation, starting non-invasive ventilation with face mask (1 hour) followed by assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated.
Group 2Assisted deep inspiration techniqueAfter extubation, starting early supplemental oxygen with Venturi (FiO2 50%) with gradual weaning, applying assisted deep inspiration technique with Voldyne(R) with four sets of 10 repetitions and assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated.
Primary Outcome Measures
NameTimeMethod
Pulmonary complications72 hours

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

Secondary Outcome Measures
NameTimeMethod
Exams72 hours

Assessment of (Sat O2) capillary saturation, (ABG) arterial blood gases.

Trial Locations

Locations (1)

Santa Casa Votuporanga

🇧🇷

Votuporanga, São Paulo, Brazil

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