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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
University Hospital Birmingham NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring physiotherapy, rehabilitation, critical care, seating

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 28, 2016
    Last Updated
    May 3, 2017
    Sponsor
    University Hospital Birmingham NHS Foundation Trust
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    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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