cardiac surgery
ProcedureAny type of cardiac surgery
NCT Number: NCT03552887
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.
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Notify Me18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Any type of cardiac surgery
Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol
Time frame: 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.
Time frame: 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)
Time frame: Until hospital discharge, up to 24 months
Number of deaths
Time frame: Until ICU discharge, up to 24 months
Number of days in ICU
Time frame: Until hospital discharge, up to 24 months
Number of days in hospital
University of Sao Paulo General Hospital
Other
Acronym: Adephysio
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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