Adverse Events During Physiotherapy at Intensive Care Unit In Patients Undergoing Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 323
- Primary Endpoint
- Adverse Event
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing cardiac surgery
- •Age ≥ 18 years old
- •Patients who are receiving any physiotherapy intervention
Exclusion Criteria
- •Neurological and cognitive impairment
Outcomes
Primary Outcomes
Adverse Event
Time Frame: until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months
Occurrence of adverse events during all physiotherapy interventions.
Secondary Outcomes
- Grade of adverse event(until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months)
- Mortality Rate(Until hospital discharge, up to 24 months)
- ICU Length of Stay(Until ICU discharge, up to 24 months)
- Hospital Length of Stay(Until hospital discharge, up to 24 months)
Investigators
Emilia Nozawa, PT PhD
Vice Director, Physiotherapy Department
University of Sao Paulo General Hospital