Thoracic Surgery Clinical Trial
Official title:
Expiratory Positive Pressure With Blow-bottle Device Versus Expiratory Positive Airway Pressure (EPAP) in Patients After Postoperative Cardiac Surgery: Randomized Clinical Trial
NCT number | NCT03639974 |
Other study ID # | 17-0460 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2018 |
Est. completion date | August 23, 2019 |
Verified date | December 2019 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 163 |
Est. completion date | August 23, 2019 |
Est. primary completion date | May 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | HCPA | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre | UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS) |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary function - forced vital capacity | Pulmonary function through spirometry. Spirometry allows to measure forced vital capacity. It's the air volume expired, quickly, after an inspiration deep maximum. | three days | |
Primary | Pulmonary function - forced expiratory volume in the first second | 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 . | three days | |
Primary | Pulmonary function - the ratio: forced expiratory volume in the first second / forced vital capacity | 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. | three days | |
Secondary | Respiratory muscle strength - maximum expiratory pressure | Performed through a manometer in step cmH2O, of the brand Globalmed model MV300. Maximum expiratory pressure. | three days | |
Secondary | Respiratory muscle strength - maximal inspiratory pressure | Performed through a manometer in step cmH2O, of the brand Globalmed model MV300. Maximal inspiratory pressure will be measured. | three days | |
Secondary | Pulmonary complications - atelectasis | According to the definitions of the European Journal of Anaesthesiology | three days | |
Secondary | Pulmonary complications - pleural effusion | According to the definitions of the European Journal of Anaesthesiology | three days | |
Secondary | Pulmonary complications - pneumothorax | According to the definitions of the European Journal of Anaesthesiology | three days | |
Secondary | Pulmonary complications - pneumonia | According to the definitions of the European Journal of Anaesthesiology | three days | |
Secondary | Pulmonary complications - respiratory infection | According to the definitions of the European Journal of Anaesthesiology | three days | |
Secondary | Pulmonary complications - respiratory failure | According to the definitions of the European Journal of Anaesthesiology | three days | |
Secondary | Radiological changes - pleural effusion | rated on chest X-ray, according to the scale proposed by Staton et al. | three days | |
Secondary | Radiological changes - atelectasis | rated on chest X-ray, according to the scale proposed by Staton et al. | three days | |
Secondary | Radiological changes - consolidation | rated on chest X-ray, according to the scale proposed by Staton et al. | three days | |
Secondary | Radiological changes - pneumothorax | rated on chest X-ray, according to the scale proposed by Staton et al. | three days | |
Secondary | Radiological changes - pulmonary edema | rated on chest X-ray, according to the scale proposed by Staton et al. | three days | |
Secondary | Length of Intensive Care Unit (ICU) stay | Length of ICU stay (days) search electronic records | three days | |
Secondary | Length of hospital stay | Length of hospital stay (days) search electronic records | up to 25 days |
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