Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552887
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Emilia Nozawa, PT PhD, University of Sao Paulo General Hospital

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
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.


Layout table for study information
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 : June 1, 2016
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. Mortality Rate [ Time Frame: Until hospital discharge, up to 24 months ]
    Number of deaths

  3. ICU Length of Stay [ Time Frame: Until ICU discharge, up to 24 months ]
    Number of days in ICU

  4. Hospital Length of Stay [ Time Frame: Until hospital discharge, up to 24 months ]
    Number of days in hospital



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Neurological and cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552887


Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Emilia Nozawa, PhD, PT Instituto do Coracao, Hospital das Clinicas, USP

Layout table for additonal information
Responsible Party: Emilia Nozawa, PT PhD, Vice Director, Physiotherapy Department, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03552887     History of Changes
Other Study ID Numbers: 1391854
51256215.5.0000.0068 ( Other Identifier: CAAE )
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual personal data will be disclosed

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emilia Nozawa, PT PhD, University of Sao Paulo General Hospital:
Adverse Event
Physiotherapy
Cardiac Surgery