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

NCT ID: NCT03143777

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-04-30

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.

Conditions

Critical Illness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Baseline

Standard physiotherapy and mobilisation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Sara Combilizer group

Ongoing care with the sara combilizer available for use

Group Type: EXPERIMENTAL

Sara Combilizer

Intervention Type: DEVICE

Combined tilt table and stretcher chair

Interventions

Sara Combilizer

Combined tilt table and stretcher chair

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

David McWilliams

Clinical Specialist Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

UBirminghamNHS1

Identifier Type: -

Identifier Source: org_study_id