Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pneumonia Pleural Effusion Atelectasis |
Procedure: Continuous Positive Airway Pressure (CPAP) facial mask Procedure: Assisted deep inspiration technique |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Incentive Spirometry Decreases Respiratory Complications After Myocardial Revascularization |
- Pulmonary complications [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]Occurrence of pulmonary complications such as pneumonia, atelectasis or pleural effusion diagnosed with chest X-rays by ICU doctor.
- Exams [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]Assessment of (Sat O2) capillary saturation, (ABG) arterial blood gases.
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
After 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.
|
Procedure: Continuous Positive Airway Pressure (CPAP) facial mask
After 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.
Other Name: CPAP
|
|
Experimental: Group 2
After 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.
|
Procedure: Assisted deep inspiration technique
After 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.
Other Names:
|
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| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Marcos Aurelio Barboza de Oliveira, MD | +55 17 91256384 | m_aurelio@sbccv.org.br |
| Brazil | |
| Santa Casa Votuporanga | Recruiting |
| Votuporanga, São Paulo, Brazil, 15500-003 | |
| Contact: Marcos Aurelio Barboza de Oliveira +55 17 3405 9134 comunicacao@santacasavotuporanga.com.br | |
| Principal Investigator: Marcos Aurelio Barboza de Oliveira, MD | |
| Principal Investigator: | Marcos Aurelio Barboza de Oliveira, MD | Santa Casa Votuporanga |
More Information
No publications provided
| Responsible Party: | Marcos Aurelio Barboza de Oliveira, M.D., Santa Casa de Votuporanga |
| ClinicalTrials.gov Identifier: | NCT01416519 History of Changes |
| Other Study ID Numbers: | U1111-1123-6476, 0035/2010 |
| Study First Received: | August 12, 2011 |
| Last Updated: | September 1, 2011 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Santa Casa de Votuporanga:
|
Continuous Positive Airway Pressure Cough Oxygen Inhalation Therapy |
Additional relevant MeSH terms:
|
Pulmonary Atelectasis Pleural Effusion Pneumonia Lung Diseases |
Respiratory Tract Diseases Pleural Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 19, 2013