Clinical trial NCT03552887: Adverse Events During Physiotherapy at Intensive Care Unit In Patients Undergoing Cardiac Surgery
Official title: Adverse Events During Physiotherapy at Intensive Care Unit In Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Event
Physiotherapy
Intensive Care Units
Cardiac Surgery
Postoperative
Keywords: Adverse Event
Physiotherapy
Cardiac Surgery
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery
* Age ≥ 18 years old
* Patients who are receiving any physiotherapy intervention

Exclusion Criteria:

* Neurological and cognitive impairment

Primary outcomes:
measure: Adverse Event
timeFrame: until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months
Secondary outcomes:
measure: Grade of adverse event
timeFrame: until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months
measure: Mortality Rate
timeFrame: Until hospital discharge, up to 24 months
measure: ICU Length of Stay
timeFrame: Until ICU discharge, up to 24 months
measure: Hospital Length of Stay
timeFrame: Until hospital discharge, up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Instituto do Coracao, Hospital das Clinicas, USP
name: Emilia Nozawa, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: