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

NCT03143777 | Completed Phase 1

• 1 other identifier: UBirminghamNHS1
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Critical Illness

Keywords

physiotherapy; rehabilitation; critical care; seating

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• SOFA score

  Throughout ICU admission, average of 2 weeks

Study Arms (2)

Baseline

NO INTERVENTION

Standard physiotherapy and mobilisation

Sara Combilizer group

EXPERIMENTAL

Ongoing care with the sara combilizer available for use

Device: Sara Combilizer

Interventions

Sara Combilizer DEVICE

Combined tilt table and stretcher chair

Sara Combilizer group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Specialist Physiotherapist

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 8, 2017
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share