Skip to main content
OpenTrials
Completed

NCT Number: NCT03552887

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Neurological and cognitive impairment

Treatment and study plan

cardiac surgery

Procedure

Any type of cardiac surgery

physiotherapy

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Acronym: Adephysio

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 12, 2018
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.