Positive Expiratory Pressure With Blow-bottle Device Versus EPAP After Postoperative Cardiac Surgery
- Conditions
- Thoracic Surgery
- Interventions
- Other: EPAPOther: PEP in a blow-bottle deviceOther: conventional physiotherapy
- Registration Number
- NCT03639974
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief Summary
Cardiac surgery is a recommended therapeutic option as a form of secondary prevention for the treatment of cardiovascular diseases, but may present postoperative alterations such as reduction of pulmonary volumes and flows, impairment in gas exchange and increase in the rate of pulmonary complications. The use of positive pressure may reduce these complications. Objective: To evaluate the efficacy of positive expiratory pressure (PEP) in the blow-bottle device compared to expiratory positive airway pressure (EPAP), both associated with conventional physiotherapy, and conventional physiotherapy in the pulmonary function in postoperative cardiac patients through a randomized clinical trial. Methods: The study was approved by the Research Ethics Committee of the Hospital de Clínicas of Porto Alegre (CAEE: 70213617.6.0000.5327). Patients undergoing cardiac surgery were randomized into three groups: positive expiratory pressure with blow-bottle device associated with conventional physiotherapy (G1), positive expiratory pressure in the airways with unidirectional valve associated with conventional physiotherapy (G2), and the third group only the conventional physiotherapy of HCPA cardiac intensive care unit (G3). Initially, an evaluation was performed through spirometry, manovacuometry, radiological changes in the preoperative period, prior to the interventions (immediate postoperative) and on the third postoperative day, immediately prior to cardiac intensive care unit discharge. Pulmonary complications were assessed on the third postoperative day, and length of stay (at the Intensive Care Unit and hospital) were recorded untill discharge.
- Detailed Description
Cardiac surgery is a recommended therapeutic option as a form of secondary prevention for the treatment of cardiovascular diseases, but may present postoperative alterations such as reduction of pulmonary volumes and flows, impairment in gas exchange and increase in the rate of pulmonary complications. The use of positive pressure may reduce these complications. Objective: To evaluate the efficacy of positive expiratory pressure (PEP) in the blow-bottle device compared to expiratory positive airway pressure (EPAP), both associated with conventional physiotherapy, and conventional physiotherapy in the pulmonary function in postoperative cardiac patients. Methods:This is a randomized clinical trial, with patients in postoperative cardiac surgery. On the first day of postoperative, the patients will be randomized into three groups: 1 group that will receive positive expiratory pressure with blow-bottle device associated with conventional physiotherapy; 2- group that will receive positive expiratory pressure in the airways with valve unidirectional therapy associated with conventional physiotherapy; 3- group that will only receive conventional physiotherapy. The intervention of the positive expiratory pressure with blow-bottle device group will consist of exercise with a blow-bottle device of 10 cm high; the positive expiratory pressure in the airways group, exercise with unidirectional positive expiratory pressure valve (10cmH2O). Both the groups will perform three sets of 10 repetitions per day, by the third day of PO. The third group will receive conventional physiotherapy of intensive care unit. The outcomes evaluated will be: pulmonary function (primary), respiratory muscle strength, pulmonary complications, radiological changes and length of stay (at the Intensive CareUnit - ICU - and hospital). Assessment of pulmonary function, muscle strength and radiological changes will be performed in the preoperative period, prior to the interventions and on the third postoperative day, immediately prior to discharge of cardiac intensive care unit. Pulmonary complications and ICU length of stay will be recorded after discharge from intensive care unit cardiac. The length of hospital stay was recorded after hospital discharge.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
Elective cardiovascular surgery of:
coronary artery bypass graft surgery alone
coronary artery bypass graft surgery combined with aortic valve surgery
coronary artery bypass graft surgery combined with bicuspid valve surgery
coronary artery bypass graft surgery combined with tricuspid valve surgery
Aortic valve surgery
Bicuspid valve surgery
Tricuspid valve surgery
All on spontaneous ventilation or with supplemental oxygen support.
Patients with hemodynamic instability (heart rate> 120bpm, clinically important hypotension - vasopressor dose ≥ 0.1mcg / kg / min)
Cardiac arrhythmia
Heart transplantation
Angina at rest and/or minor efforts
Mechanical ventilation for more than 24 hours
Re-hospitalized patients with decompensated heart failure
Noninvasive mechanical ventilation
Non-collaborative and with cognitive inability to understand the procedures
Reintubated patients
Re-operated patients
In order to perform the pulmonary function test, patients may not present the following contraindications:
hemoptysis
recent angina
retinal detachment
hypertensive crisis
pulmonary edema
thoracic aortic aneurysm
In order to perform the respiratory muscle strength test, patients may not present the following contraindications:
acute myocardial infarction
recent unstable angina
severe and uncontrolled systemic arterial hypertension
aortic aneurysm
pneumothorax
pleurocutaneous or pulmonary fistulas
surgery or recent trauma to the upper airways, chest or abdomen
abdominal hernia
acute middle ear problems
glaucoma or retinal detachment
hydrocephalus
meningocele
neurological processes that favor the choking of tonsils
general state of physical or mental impairment that impedes the patient's collaboration.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EPAP Positive airway expiratory pressure EPAP EPAP with pressure of 10 cmH2O. PEP in a blow-bottle device PEP in a blow-bottle device Blow-bottle device of 10cmH2O. conventional physiotherapy conventional physiotherapy Ventilatory exercises, bronchial hygiene techniques, exercises for upper and lower limbs (previous motor condition) stretching, orientation and walking.
- Primary Outcome Measures
Name Time Method Pulmonary function - forced expiratory volume in the first second three days Pulmonary function through spirometry, that allows to measure forced expiratory volume in the first second. It's the maximum expired volume at the first second of an maximum expiration .
Pulmonary function - forced vital capacity three days Pulmonary function through spirometry. Spirometry allows to measure forced vital capacity. It's the air volume expired, quickly, after an inspiration deep maximum.
Pulmonary function - the ratio: forced expiratory volume in the first second / forced vital capacity three days Pulmonary function through spirometry, obtained through forced maneuver (forced vital capacity) and forced expiratory volume in the first second - represents the maximum expired volume at the first second of an maximum expiration.
- Secondary Outcome Measures
Name Time Method Pulmonary complications - atelectasis three days According to the definitions of the European Journal of Anaesthesiology
Pulmonary complications - pleural effusion three days According to the definitions of the European Journal of Anaesthesiology
Pulmonary complications - pneumothorax three days According to the definitions of the European Journal of Anaesthesiology
Pulmonary complications - pneumonia three days According to the definitions of the European Journal of Anaesthesiology
Pulmonary complications - respiratory infection three days According to the definitions of the European Journal of Anaesthesiology
Radiological changes - pneumothorax three days rated on chest X-ray, according to the scale proposed by Staton et al.
Radiological changes - pulmonary edema three days rated on chest X-ray, according to the scale proposed by Staton et al.
Respiratory muscle strength - maximal inspiratory pressure three days Performed through a manometer in step cmH2O, of the brand Globalmed model MV300. Maximal inspiratory pressure will be measured.
Pulmonary complications - respiratory failure three days According to the definitions of the European Journal of Anaesthesiology
Radiological changes - atelectasis three days rated on chest X-ray, according to the scale proposed by Staton et al.
Radiological changes - consolidation three days rated on chest X-ray, according to the scale proposed by Staton et al.
Length of Intensive Care Unit (ICU) stay three days Length of ICU stay (days) search electronic records
Respiratory muscle strength - maximum expiratory pressure three days Performed through a manometer in step cmH2O, of the brand Globalmed model MV300. Maximum expiratory pressure.
Radiological changes - pleural effusion three days rated on chest X-ray, according to the scale proposed by Staton et al.
Length of hospital stay up to 25 days Length of hospital stay (days) search electronic records
Trial Locations
- Locations (1)
HCPA
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil