Adverse Events During Physiotherapy at Intensive Care Unit In Patients Undergoing Cardiac Surgery (Adephysio)
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|ClinicalTrials.gov Identifier: NCT03552887|
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment|
|Adverse Event Physiotherapy Intensive Care Units Cardiac Surgery Postoperative||Procedure: Cardiac Surgery Procedure: Physiotherapy|
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 Type :||Observational|
|Actual Enrollment :||323 participants|
|Official Title:||Adverse Events During Physiotherapy at Intensive Care Unit In Patients Undergoing Cardiac Surgery|
|Actual Study Start Date :||June 1, 2016|
|Actual Primary Completion Date :||November 30, 2017|
|Actual Study Completion Date :||November 30, 2017|
Cohort of patients undergoing cardiac surgery, aged ≥ 18 years old, who had received any physiotherapy intervention
Procedure: Cardiac Surgery
Any type of cardiac surgery
Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol
- Adverse Event [ 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.
- Grade of adverse event [ 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)
- Mortality Rate [ Time Frame: Until hospital discharge, up to 24 months ]Number of deaths
- ICU Length of Stay [ Time Frame: Until ICU discharge, up to 24 months ]Number of days in ICU
- Hospital Length of Stay [ Time Frame: Until hospital discharge, up to 24 months ]Number of days in hospital
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552887
|Principal Investigator:||Emilia Nozawa, PhD, PT||Instituto do Coracao, Hospital das Clinicas, USP|