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

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Adverse Event
Cardiac Surgery
Intensive Care Units
Physiotherapy
Postoperative

Treatments

Procedure: Physiotherapy
Procedure: Cardiac Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT03552887
51256215.5.0000.0068 (Other Identifier)
1391854

Details and patient eligibility

About

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.

Full 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.

Enrollment

323 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Neurological and cognitive impairment

Trial design

323 participants in 1 patient group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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