Does the Sara Combilizer®, an Early Mobilization Aid, Reduce the Time Taken to First Mobilise Ventilated Patients in Intensive Care?

May 3, 2017 updated by: David McWilliams, University Hospital Birmingham NHS Foundation Trust
This study investigates the impact of introducing an early mobilisation device called the Sara Combilizer on time taken to mobilise in critical care. The investigators will collect baseline data on time taken to mobilise for a period of 4 months, then following a training programme and introduction of the device for a further 4 months

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Early mobility within the ICU is associated with a number of positive outcomes including reductions in ICU and hospital length of stay and better functional recovery. The exact definition of 'early' mobility is still not defined, with the actual ability to mobilize limited by a number of perceived factors.

The Sara Combilizer is a combined tilt table and stretcher chair, which allows passive transfer of patients out of bed. It is theorized the passive and safe nature of transfer may facilitate earlier mobilisation of patients within critical care. This study aimed to assess whether the introduction of the Sara Combilizer reduced time taken to first mobilize for patients mechanically ventilated for at least 5 days and at risk of ICU acquired weakness.

Patients admitted to a large UK critical care unit during the trial period and ventilated for ≥ 5 days were included in the study. Baseline data was collected prospectively for a period of 4 months. The Sara Combilizer was then introduced for a 1 month training and familiarization period, followed by a further 4 months prospective data collection.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

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

Description

Inclusion Criteria:

  • All adult patients (>18 years) admitted to critical care and ventilated for 5 days or more

Exclusion Criteria:

  • Patients with contraindications to mobilise (e.g. pelvic / spinal fractures)
  • Poor prior level of mobility (<10yards)
  • Neuromuscular disease (e.g. Guillain Barre or Motor Neurone Disease)
  • Mechanical ventilation > 48 hours at another facility prior to admission
  • Expected withdrawal of treatment within 24 next hours
  • Patients who have already commenced mobilisation in the 1st 5 days of admission
  • Obese patients who exceed the weight limit of the product (200 kg)
  • Patients over 6ft5 due to restrictions of the product
  • Severe neurological injury
  • Lower limb amputations

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

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Baseline
Standard physiotherapy and mobilisation
EXPERIMENTAL: Sara Combilizer group
Ongoing care with the sara combilizer available for use
Device: Sara Combilizer
Combined tilt table and stretcher chair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time taken to 1st mobilise
Time Frame: Throughout ICU admission, average of 2 weeks
Time taken to commence mobilisation , defined as sitting on the edge of the bed or out in a chair
Throughout ICU admission, average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOFA score
Time Frame: Throughout ICU admission, average of 2 weeks
SOFA scores were calculated to measure degree of organ failure at the time of 1st mobilisation
Throughout ICU admission, average of 2 weeks

Collaborators and Investigators

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

Sponsor

University Hospital Birmingham NHS Foundation Trust

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

April 1, 2014

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

May 3, 2017

First Posted (ACTUAL)

May 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBirminghamNHS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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