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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adverse Event, Physiotherapy, Intensive Care Units, Cardiac Surgery, Postoperative

Intervention / Treatment
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* Procedure: Cardiac Surgery
* Procedure: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing cardiac surgery Age ≥ 18 years old Patients who are receiving any physiotherapy intervention Exclusion Criteria: Neurological and cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postoperative patients<br>Cohort of patients undergoing cardiac surgery, aged ≥ 18 years old, who had received any physiotherapy intervention | Procedure: Cardiac Surgery<br>* Any type of cardiac surgery<br>Procedure: Physiotherapy<br>* Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | Occurrence of adverse events during all physiotherapy interventions. | until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of adverse event | 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) | until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months | 
| Mortality Rate | Number of deaths | Until hospital discharge, up to 24 months | 
| ICU Length of Stay | Number of days in ICU | Until ICU discharge, up to 24 months | 
| Hospital Length of Stay | Number of days in hospital | Until hospital discharge, up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adverse Event, Physiotherapy, Cardiac Surgery