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

Cardiac Surgery Clinical Trial

— Adephysio  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552887
• Other study ID #: 1391854
• Secondary ID: 51256215.5.0000.
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: June 2018
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing cardiac surgery

• Age = 18 years old

• Patients who are receiving any physiotherapy intervention

Exclusion Criteria:

• Neurological and cognitive impairment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Cardiac Surgery
Any type of cardiac surgery
• Physiotherapy
Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mortality Rate	Number of deaths	Until hospital discharge, up to 24 months
Secondary	ICU Length of Stay	Number of days in ICU	Until ICU discharge, up to 24 months
Secondary	Hospital Length of Stay	Number of days in hospital	Until hospital discharge, up to 24 months