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Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation

NCT03133377 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2023-12-18

No results posted yet for this study

Summary

The aim of this study is to evaluate the effect of early activity and mobilisation during prolonged IMV on the composite outcome "days alive and out of hospital to day 180". The effect of the intervention on mortality, physical, cognitive and psychological function at 180 days, as well as cost-effectiveness of the intervention, will also be evaluated. The study will also explore process of care measures and baseline physiology and ICU mobility outcomes.

The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and mobilisation increases the number of days alive and at home to day 180 when compared with standard care.

Conditions

  • Critically Ill, Mechanically Ventilated

Interventions

BEHAVIORAL

Early activity and mobilisation

The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • ANZICS Clinical Trials Group

    collaborator NETWORK

  • Medical Research Institute of New Zealand

    collaborator OTHER

  • Intensive Care National Audit & Research Centre

    collaborator OTHER

  • Australian and New Zealand Intensive Care Research Centre

    lead OTHER

Principal Investigators

  • Carol Hodgson, Prof · ANZIC-RC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2022-05-18
Completion
2022-11-10

Countries

  • Australia
  • Germany
  • Ireland
  • New Zealand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03133377 on ClinicalTrials.gov