Device-assisted mobilization for critically ill patients
Randomised Pilot Study on Device-assisted Mobilisation With a Sit/Stand Stabiliser of Critically Ill Patients With Ventilatory Support
This study is testing if using a special device to help critically ill patients move around can improve their mobility and recovery compared to just standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05716451 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of the Liana® mobilizer in facilitating early mobilization of critically ill patients in the ICU and post-anesthesia care unit. The study will compare the frequency of achieving an ICU mobility scale score of 4 or higher among patients receiving device-assisted mobilization versus standard care. Secondary objectives include assessing the impact on healthcare staff workload, patient functional outcomes, and patient perceptions of the intervention. The study targets patients with organ insufficiency and those requiring breathing assistance, focusing on improving mobility and reducing muscle weakness associated with prolonged ICU stays.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving ventilatory support in the ICU with an expected stay of at least 48 hours.
Not a fit: Patients who are moribund, have a high risk of mortality, or have severe neurological or musculoskeletal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the physical recovery of critically ill patients, reducing long-term complications associated with muscle weakness.
How similar studies have performed: Previous studies have shown positive outcomes with high levels of mobilization in ICU patients, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Intensive care patient with ventilatory support and an expected intensive care stay of at least another 48 h * Age ≥ 18 years * Current length of intensive care stay \< 48 h Exclusion Criteria: * Moribund and critically ill * Suspected 6-month mortality \> 75%. * Increased intracranial pressure * Critically ill after cardiopulmonary resuscitation * Critically ill with primary neuromuscular disease or motor neuron disease * One or more amputated extremities * Patients, within 2h after surgery * Unstable fractures * Severe traumatic brain injury (e.g., brain and skull injuries) * Circulatory instability with norepinephrine \> 0.3 µg/kg/min * Patients for whom there is an indication for deep sedation (RASS -5) * Language barrier * Fitting of legs into leg trays is not possible due to e.g. patient weight
Where this trial is running
Berlin
- Charité - Univiversitätsmedizin Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Stefan J Schaller, MD — Charite University, Berlin, Germany
- Study coordinator: Stefan J Schaller, MD
- Email: stefan.schaller@charite.de
- Phone: +49-30-450-5311052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.