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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03143777
Enrollment
80
Registered
2017-05-08
Start date
2014-04-30
Completion date
2015-04-30
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

physiotherapy, rehabilitation, critical care, seating

Brief summary

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

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.

Interventions

DEVICESara Combilizer

Combined tilt table and stretcher chair

Sponsors

University Hospital Birmingham NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time taken to 1st mobiliseThroughout ICU admission, average of 2 weeksTime taken to commence mobilisation , defined as sitting on the edge of the bed or out in a chair

Secondary

MeasureTime frameDescription
SOFA scoreThroughout ICU admission, average of 2 weeksSOFA scores were calculated to measure degree of organ failure at the time of 1st mobilisation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026