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Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation

Primary Purpose

Pneumonia, Pleural Effusion, Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP) facial mask
Assisted deep inspiration technique
Sponsored by
Santa Casa de Votuporanga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia focused on measuring Continuous Positive Airway Pressure, Cough, Oxygen Inhalation Therapy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Santa Casa Votuporanga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2011
Last Updated
November 17, 2014
Sponsor
Santa Casa de Votuporanga
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1. Study Identification

Unique Protocol Identification Number
NCT01416519
Brief Title
Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation
Official Title
Incentive Spirometry Decreases Respiratory Complications After Myocardial Revascularization
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Santa Casa de Votuporanga

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pleural Effusion, Atelectasis
Keywords
Continuous Positive Airway Pressure, Cough, Oxygen Inhalation Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP) facial mask
Other Intervention Name(s)
CPAP
Intervention Description
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
Intervention Name(s)
Assisted deep inspiration technique
Other Intervention Name(s)
Voldyne
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary complications
Description
Occurrence of pulmonary complications such as pneumonia, atelectasis or pleural effusion diagnosed with chest X-rays by ICU doctor.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Exams
Description
Assessment of (Sat O2) capillary saturation, (ABG) arterial blood gases.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcos Aurelio Barboza de Oliveira, MD
Organizational Affiliation
Santa Casa Votuporanga
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Casa Votuporanga
City
Votuporanga
State/Province
São Paulo
ZIP/Postal Code
15500-003
Country
Brazil

12. IPD Sharing Statement

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Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation

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