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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143777
• Other study ID #: UBirminghamNHS1
• Status: Completed
• Phase: Phase 1
• First received: April 28, 2016
• Last updated: May 3, 2017
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2017
• Source: University Hospital Birmingham NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• Sara Combilizer
Combined tilt table and stretcher chair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Birmingham NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time taken to 1st mobilise	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	SOFA score	SOFA scores were calculated to measure degree of organ failure at the time of 1st mobilisation	Throughout ICU admission, average of 2 weeks