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

Completed

• Conditions: Adverse Event; Physiotherapy; Intensive Care Units; Cardiac Surgery; Postoperative
• Interventions: Procedure: Cardiac Surgery; Procedure: Physiotherapy

• Registration Number: NCT03552887
• Lead Sponsor: University of Sao Paulo General Hospital

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 Timeline

• Study Start: 2016-06-01
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-05-30
• Status Verified: 2018-06
• Study First Posted: 2018-06-12
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

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

Exclusion Criteria

• Neurological and cognitive impairment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postoperative patients	Cardiac Surgery	Cohort of patients undergoing cardiac surgery, aged ≥ 18 years old, who had received any physiotherapy intervention
Postoperative patients	Physiotherapy	Cohort of patients undergoing cardiac surgery, aged ≥ 18 years old, who had received any physiotherapy intervention

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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