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| ID | Type | Description | Link |
|---|---|---|---|
| 51256215.5.0000.0068 | Other Identifier | CAAE |
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This study aims to estimate the incidence of adverse events during physiotherapy at intensive care unit (ICU) in adult patients undergoing cardiac surgery and to identify predictors of those events. This is a prospective cohort study, and the investigators observed all types of physiotherapy interventions in patients admitted at surgical ICU.
Physiotherapy intervention practice in patients after cardiac surgery has been associated with better clinical outcomes, but the safety of such interventions are not fully understood.
A prospective observational study of patients admitted at surgical ICU, aged > 18 years old, undergoing cardiac surgery was conducted to estimate the incidence of adverse events during physiotherapy interventions in those patients and to identify predictors of adverse events.
Physiotherapy interventions were observed, performed by physiotherapists outside of the protocol. The occurrence of adverse events or physiological abnormality were recorded, classifying them according to the symptomatic consequences for the patient, from grade 1 ("near miss", additional intervention not required) to grade 5 (death). The investigators collected clinical characteristics of patients, such as sequential organ failure assessment (SOFA) score, comorbidities, sedation leve and pain. Participants were followed up to hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative patients | Cohort of patients undergoing cardiac surgery, aged ≥ 18 years old, who had received any physiotherapy intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Surgery | Procedure | Any type of cardiac surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Occurrence of adverse events during all physiotherapy interventions. | until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of adverse event | Grade of observed adverse event according to the symptomatic consequences for the patient, from grade 1 ("near miss", additional intervention not required) to grade 5 (death) | until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months |
| Mortality Rate |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted at surgical ICU, undergoing cardiac surgery, and who had receive any physiotherapy intervention, at Instituto do Coracao - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Brazil
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| Name | Affiliation | Role |
|---|---|---|
| Emilia Nozawa, PhD, PT | Instituto do Coracao, Hospital das Clinicas, USP | Principal Investigator |
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No individual personal data will be disclosed
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| ID | Term |
|---|---|
| D006348 | Cardiac Surgical Procedures |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
| D013812 | Therapeutics |
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| Physiotherapy |
| Procedure |
Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol |
|
Number of deaths |
| Until hospital discharge, up to 24 months |
| ICU Length of Stay | Number of days in ICU | Until ICU discharge, up to 24 months |
| Hospital Length of Stay | Number of days in hospital | Until hospital discharge, up to 24 months |
| D012046 | Rehabilitation |