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Completed

NCT Number: NCT01416519

Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Casa Votuporanga

Votuporanga, São Paulo, 15500-003, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure (CPAP) facial mask

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.

Other names: CPAP

Assisted deep inspiration technique

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.

Other names: Voldyne

Primary outcomes

  1. Pulmonary complications

    Time frame: 72 hours

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

Secondary outcomes

  1. Exams

    Time frame: 72 hours

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

Sponsors and collaborators

Lead sponsor

Santa Casa de Votuporanga

Other

Registry information

Official study title

Incentive Spirometry Decreases Respiratory Complications After Myocardial Revascularization

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 15, 2011
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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