NCT03552887

Adverse Events During Physiotherapy at Intensive Care Unit In Patients Undergoing Cardiac Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 323 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adverse Event
• Physiotherapy
• Intensive Care Units
• Cardiac Surgery
• Postoperative

Interventions

Type	Name	Description
PROCEDURE	Cardiac Surgery	Any type of cardiac surgery
PROCEDURE	Physiotherapy	Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-11-30
• Completion: 2017-11-30
• First posted: 2018-06-12
• Last updated: 2018-06-25