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Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation

Incentive Spirometry Decreases Respiratory Complications After Myocardial Revascularization

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01416519
Enrollment
200
Registered
2011-08-15
Start date
2011-09-30
Completion date
2014-01-31
Last updated
2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atelectasis, Pleural Effusion, Pneumonia

Keywords

Continuous Positive Airway Pressure, Cough, Oxygen Inhalation Therapy

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.

Interventions

PROCEDUREContinuous 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.

PROCEDUREAssisted 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.

Sponsors

Santa Casa de Votuporanga
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary complications72 hoursOccurrence of pulmonary complications such as pneumonia, atelectasis or pleural effusion diagnosed with chest X-rays by ICU doctor.

Secondary

MeasureTime frameDescription
Exams72 hoursAssessment of (Sat O2) capillary saturation, (ABG) arterial blood gases.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026