Critical IllnessPhase 1NCT03143777
Does the Sara Combilizer®, an Early Mobilization Aid, Reduce the Time Taken to First Mobilise Ventilated Patients in Intensive Care?
A Phase 1 study testing Sara Combilizer in people with Critical Illness, run by University Hospital Birmingham NHS Foundation Trust.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Sara Combilizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (>18 years) admitted to critical care and ventilated for 5 days or more
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
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
Read the 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
- Being tested
- Sara Combilizer
- Keywords
- physiotherapy, rehabilitation, critical care, seating
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sara CombilizerDevice
Combined tilt table and stretcher chair
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Standard physiotherapy and mobilisation |
| Sara Combilizer group | Experimental | Ongoing care with the sara combilizer available for use Receives: Device: Sara Combilizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken to 1st mobilise
Time taken to commence mobilisation , defined as sitting on the edge of the bed or out in a chair
Measured: Throughout ICU admission, average of 2 weeks
Secondary outcomes (1)
SOFA score
SOFA scores were calculated to measure degree of organ failure at the time of 1st mobilisation
Measured: Throughout ICU admission, average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David McWilliams, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143777
- Sponsor's protocol ID
- UBirminghamNHS1
- Status last verified
- May 2017
- First submitted
- 28 Apr 2016
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Sara Combilizer®, an Early Mobilization Aid, Reduce the Time Taken to First Mobilise Ventilated Patients in Intensive Care?
- ClinicalTrials.gov ID
- NCT03143777
- Acronym / sponsor ID
- UBirminghamNHS1
- Conditions
- Critical Illness
- Keywords
- physiotherapy, rehabilitation, critical care, seating
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Standard physiotherapy and mobilisation |
| Sara Combilizer group | Experimental | Device: Sara CombilizerOngoing care with the sara combilizer available for use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (>18 years) admitted to critical care and ventilated for 5 days or more
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sara CombilizerCombined tilt table and stretcher chair | Device | Sara Combilizer group |
Primary outcome
Time taken to 1st mobilise
Time frame: Throughout ICU admission, average of 2 weeks
Time taken to commence mobilisation , defined as sitting on the edge of the bed or out in a chair
1 secondary outcome
SOFA score
Time frame: Throughout ICU admission, average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sara Combilizer in people with Critical Illness, run by University Hospital Birmingham NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken to 1st mobilise (time frame: Throughout ICU admission, average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017; AzTrials last refreshed its copy on 2 Nov 2026.