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

June 20, 2018 updated by: Emilia Nozawa, PT PhD, University of Sao Paulo General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted at surgical ICU, undergoing cardiac surgery, and who had receive any physiotherapy intervention, at Instituto do Coracao - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Brazil

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Neurological and cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months
Mortality Rate
Time Frame: Until hospital discharge, up to 24 months
Number of deaths
Until hospital discharge, up to 24 months
ICU Length of Stay
Time Frame: Until ICU discharge, up to 24 months
Number of days in ICU
Until ICU discharge, up to 24 months
Hospital Length of Stay
Time Frame: Until hospital discharge, up to 24 months
Number of days in hospital
Until hospital discharge, up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

November 30, 2017

Study Completion (ACTUAL)

November 30, 2017

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (ACTUAL)

June 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 25, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1391854
  • 51256215.5.0000.0068 (OTHER: CAAE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual personal data will be disclosed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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