Does the Sara Combilizer®, an Early Mobilization Aid, Reduce the Time Taken to First Mobilise Ventilated Patients in Intensive Care?
Primary Purpose
Critical Illness
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Sara Combilizer
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring physiotherapy, rehabilitation, critical care, seating
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Baseline
Sara Combilizer group
Arm Description
Standard physiotherapy and mobilisation
Ongoing care with the sara combilizer available for use
Outcomes
Primary Outcome Measures
Time taken to 1st mobilise
Time taken to commence mobilisation , defined as sitting on the edge of the bed or out in a chair
Secondary Outcome Measures
SOFA score
SOFA scores were calculated to measure degree of organ failure at the time of 1st mobilisation
Full Information
NCT ID
NCT03143777
First Posted
April 28, 2016
Last Updated
May 3, 2017
Sponsor
University Hospital Birmingham NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03143777
Brief Title
Does the Sara Combilizer®, an Early Mobilization Aid, Reduce the Time Taken to First Mobilise Ventilated Patients in Intensive Care?
Official Title
Does the Sara Combilizer®, an Early Mobilization Aid, Reduce the Time Taken to First Mobilise Ventilated Patients in Intensive Care?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Birmingham NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
physiotherapy, rehabilitation, critical care, seating
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baseline
Arm Type
No Intervention
Arm Description
Standard physiotherapy and mobilisation
Arm Title
Sara Combilizer group
Arm Type
Experimental
Arm Description
Ongoing care with the sara combilizer available for use
Intervention Type
Device
Intervention Name(s)
Sara Combilizer
Intervention Description
Combined tilt table and stretcher chair
Primary Outcome Measure Information:
Title
Time taken to 1st mobilise
Description
Time taken to commence mobilisation , defined as sitting on the edge of the bed or out in a chair
Time Frame
Throughout ICU admission, average of 2 weeks
Secondary Outcome Measure Information:
Title
SOFA score
Description
SOFA scores were calculated to measure degree of organ failure at the time of 1st mobilisation
Time Frame
Throughout ICU admission, average of 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Does the Sara Combilizer®, an Early Mobilization Aid, Reduce the Time Taken to First Mobilise Ventilated Patients in Intensive Care?
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