Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation

NCT ID: NCT01416519

Last Updated: 2014-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-01-31

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.

Conditions

Pneumonia; Pleural Effusion; Atelectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP) facial mask

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Assisted deep inspiration technique

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

CPAP; Voldyne

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santa Casa de Votuporanga

OTHER

Sponsor Role: lead

Responsible Party

Marcos Aurelio Barboza de Oliveira

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcos Aurelio Barboza de Oliveira, MD

Role: PRINCIPAL_INVESTIGATOR

Santa Casa Votuporanga

Locations

Santa Casa Votuporanga

Votuporanga, São Paulo, Brazil

Countries

Brazil

Other Identifiers

0035/2010

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1123-6476

Identifier Type: -

Identifier Source: org_study_id