Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Santa Casa de Votuporanga.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Marcos Aurelio Barboza de Oliveira, Santa Casa de Votuporanga
ClinicalTrials.gov Identifier:
NCT01416519
First received: August 12, 2011
Last updated: September 1, 2011
Last verified: September 2011
  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

Resource links provided by NLM:


Further study details as provided by Santa Casa de Votuporanga:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:
  • Voldyne
  • assisted deep inspiration 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416519

Contacts
Contact: Marcos Aurelio Barboza de Oliveira, MD +55 17 91256384 m_aurelio@sbccv.org.br

Locations
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         
Sponsors and Collaborators
Santa Casa de Votuporanga
Investigators
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 August 20, 2014