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| Name | Class |
|---|---|
| InCor Heart Institute | OTHER |
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The most common cardiac surgeries are myocardial revascularization and valve replacement or plastic surgery. In the postoperative period of cardiac surgeries, the incidence of pulmonary complications ranges from 30% to 50% and is associated with increased length of hospital stay and morbidity and mortality. To reduce or minimize the occurrence of these complications, respiratory physiotherapy employs positive pressure reexpansion therapies, such as continuous positive airway pressure (CPAP) and positive pressure support with positive end-expiratory pressure (PS+PEEP).
The goal of this clinical trial is to compare the effects of two positive pressure therapies, CPAP versus PS+PEEP, on the incidence of pulmonary complications in patients in the postoperative period of myocardial revascularization and valve replacement or plastic surgery, with mild to moderate pulmonary dysfunction.
The main question it aims to answer is: Do patients in the immediate postoperative period of myocardial revascularization or valve replacement/plastic surgery, exhibiting mild to moderate pulmonary dysfunction, experience a comparable reversal of pulmonary conditions when treated with PS+PEEP versus CPAP?
Participants will undergo the following assessments: spirometry, respiratory muscle strength testing, handgrip strength testing, and electrical impedance tomography.
In the immediate postoperative period, participants will be randomized into two treatment groups: • Control Group PS+PEEP - application of 4 sets of 20 repetitions with PS to provide a tidal volume equal to 10ml/kg of predicted body weight, PEEP equal to 10 cmH2O, and inspired oxygen fraction (FiO2) to achieve peripheral oxygen saturation (SpO2) between 92-94%; • Experimental Group CPAP - application of CPAP at 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS+PEEP group | Active Comparator | PS+PEEP modality involves the application of two levels of positive pressure intermittently. |
|
| CPAP group | Experimental | Continuous positive airway pressure modality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PS+PEEP group | Device | Application of 4 sets of 20 repetitions with PS to provide a tidal volume equal to 10ml/kg of predicted body weight, PEEP equal to 10 cmH2O, and inspired oxygen fraction (FiO2) to achieve peripheral oxygen saturation (SpO2) between 92-94% |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of pulmonary complications in the postoperative period | Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one (5) means death before hospital discharge, and degree 4 means need of invasive mechanical ventilation due to acute respiratory failure. | Participants will be followed for 7 days after surgery. |
| Electrical impedance tomography (EIT) ventilation distribution | EIT ventilation distribution will be monitored during and 30 minutes after the therapies. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ICU stay | From the day of surgery up to ICU discharge, an expected average of 2 days, and maximum censoring at day 28 after surgery. | |
| Length of hospital stay | From the day of surgery up to hospital discharge, an expected average of 10 days, and maximum censoring at day 28 after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcia S Volpe, PhD | Contact | +551133854255 | marcia.volpe@unifesp.br |
| Name | Affiliation | Role |
|---|---|---|
| Marcia S Volpe, PhD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coração - HCFMUSP | Recruiting | São Paulo | São Paulo | 05403-900 | Brazil |
IPD will be stored at https://domusdados.unifesp.br/ All IPD that results in a publication will be shared upon reasonable request.
IPD will be avaible from 12 months to 36 months after publication.
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| CPAP group | Device | Application of CPAP of 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes. |
|
| Handgrip strength | Assessments will be conducted preoperatively, on the 5th and 7th postoperative days. |
| Maximal inspiratory and expiratory pressures | Assessments will be conducted preoperatively, on the 5th and 7th postoperative days. |
| Spirometry test results | Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and the FEV1/FVC ratio from the spirometry test will be presented as percentages of predicted values. | Spirometry will be conducted preoperatively, on the 5th and 7th postoperative days. |
| Positive pressure therapy comfort level | Comfort during positive pressure therapy will be assessed using a visual analog scale ranging from 0 to 10, where 0 represents maximum comfort and 10 represents extreme discomfort. | The level of comfort will be evaluated immediately after the first three positive pressure therapy sessions. |