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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03552887

Collaborator

(none)

323

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Event Physiotherapy Intensive Care Units Cardiac Surgery Postoperative	Procedure: Cardiac Surgery Procedure: Physiotherapy

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.

Study Design

Study Type:

Observational

Actual Enrollment :

323 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Nov 30, 2017

Actual Study Completion Date :

Nov 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Postoperative patients Cohort of patients undergoing cardiac surgery, aged ≥ 18 years old, who had received any physiotherapy intervention	Procedure: Cardiac Surgery Any type of cardiac surgery Procedure: Physiotherapy Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol

Arm

Intervention/Treatment

Postoperative patients

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

Procedure: Cardiac Surgery

Any type of cardiac surgery

Procedure: Physiotherapy

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

Outcome Measures

Primary Outcome Measures

Adverse Event [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.

Secondary Outcome Measures

Grade of adverse event [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 [Until hospital discharge, up to 24 months]
Number of deaths
ICU Length of Stay [Until ICU discharge, up to 24 months]
Number of days in ICU
Hospital Length of Stay [Until hospital discharge, up to 24 months]
Number of days in hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

Principal Investigator: Emilia Nozawa, PhD, PT, Instituto do Coracao, Hospital das Clinicas, USP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emilia Nozawa, PT PhD, Vice Director, Physiotherapy Department, University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT03552887

Other Study ID Numbers:

1391854
51256215.5.0000.0068

First Posted:

Jun 12, 2018

Last Update Posted:

Jun 25, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Emilia Nozawa, PT PhD, Vice Director, Physiotherapy Department, University of Sao Paulo General Hospital

Adverse Event

Physiotherapy

Cardiac Surgery

Study Results

No Results Posted as of Jun 25, 2018