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

NCT ID: NCT03552887

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 323 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2017-11-30

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Postoperative patients

Cohort of patients undergoing cardiac surgery, aged ≥ 18 years old, who had received any physiotherapy intervention

Cardiac Surgery

Intervention Type: PROCEDURE

Any type of cardiac surgery

Physiotherapy

Intervention Type: PROCEDURE

Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol

Interventions

Cardiac Surgery

Any type of cardiac surgery

Intervention Type: PROCEDURE

Physiotherapy

Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Neurological and cognitive impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emilia Nozawa, PT PhD

Vice Director, Physiotherapy Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emilia Nozawa, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Instituto do Coracao, Hospital das Clinicas, USP

Other Identifiers

51256215.5.0000.0068

Identifier Type: OTHER

Identifier Source: secondary_id

1391854

Identifier Type: -

Identifier Source: org_study_id