Adverse Event, Cardiac Surgery, Intensive Care Units, Physiotherapy, Postoperative
Conditions
Keywords
Adverse Event, Physiotherapy, Cardiac Surgery
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.
Interventions
PROCEDURECardiac Surgery
Any type of cardiac surgery
PROCEDUREPhysiotherapy
Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol
Sponsors
University of Sao Paulo General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | 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
| Measure | Time frame | Description |
|---|---|---|
| ICU Length of Stay | Until ICU discharge, up to 24 months | Number of days in ICU |
| Hospital Length of Stay | Until hospital discharge, up to 24 months | Number of days in hospital |
| Grade of adverse event | until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months | 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) |
| Mortality Rate | Until hospital discharge, up to 24 months | Number of deaths |
Outcome results
None listed