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OpenTrials
Completed

NCT Number: NCT03143777

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sara Combilizer

Device

Combined tilt table and stretcher chair

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital Birmingham NHS Foundation Trust

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 8, 2017
Registry last updated
May 8, 2017

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.

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