Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation

Pneumonia Clinical Trial

Official title:

Incentive Spirometry Decreases Respiratory Complications After Myocardial Revascularization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416519
• Other study ID #: U1111-1123-6476
• Secondary ID: 0035/2010
• Status: Completed
• Phase: N/A
• First received: August 12, 2011
• Last updated: November 17, 2014
• Start date: September 2011
• Est. completion date: January 2014

Study information

• Verified date: November 2014
• Source: Santa Casa de Votuporanga
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atelectasis
• Pleural Effusion
• Pneumonia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Santa Casa Votuporanga	Votuporanga	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Santa Casa de Votuporanga

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary complications	Occurrence of pulmonary complications such as pneumonia, atelectasis or pleural effusion diagnosed with chest X-rays by ICU doctor.	72 hours	Yes
Secondary	Exams	Assessment of (Sat O2) capillary saturation, (ABG) arterial blood gases.	72 hours	Yes