Critical Illness, Muscle Weakness, Respiratory Insufficiency
Conditions
Keywords
Muscle strength, functional mobility, outcome, intensive care unit, quality of life
Brief summary
The investigators hypothesize that by applying a validated algorithm to accomplish early mobilization in surgical intensive care unit (ICU) patients, these patients will achieve a higher level of mobility which translates to shorter ICU length of stay and improved functional status at discharge. Additionally, the investigators hypothesize that genetic polymorphisms related to muscle strength and sleep will also explain some variance in these outcome variables.
Detailed description
The trauma literature consistently shows that early mobilization improves patients' outcome after a localized trauma such as hip fracture, or blunt solid organ injuries. In addition, in critically ill patients on the medical ICU, early mobilization improves patients' functional outcome and decreases ICU length of stay (1). This study evaluates if critically ill patients in a surgical ICU can safely and effectively be mobilized early after trauma and surgery. The investigators propose to conduct a randomized controlled study in surgical intensive care unit patients to evaluate the effects of mSOMS guided early mobilization. Additionally, the study will examine known genetic polymorphisms as related to sleep quality and muscle strength and how it relates to early mobilization of surgical ICU patients. In particular, the study will focus on the following polymorphisms: CLOCK, NPAS2, PER2 and PER3, PDE4D,MUC1, ATP2B1, DCDC5, TRPM6, SHROOM3, and MDS1 genes.
Interventions
PROCEDURESOMS
Apply a number to mobilization goal for patient
Sponsors
Beth Israel Deaconess Medical Center
University of Massachusetts, Worcester
Technical University of Munich
University of Salzburg
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults (18 years of age or greater) * Who have been on mechanical ventilation for less than 48 hours and are expected to continue for at least 24 more hours * Who meet criteria for baseline functional independence (Barthel Index greater than or equal to 70 obtained from a proxy describing patient function 2 weeks before admission
Exclusion criteria
* Irreversible disorders with 6-month mortality greater than 50% * Rapidly developing neuromuscular disease * Cardiopulmonary arrest * Motor component of Glascow Coma Scale \<5 * Elevated intracranial pressure * Ruptured/leaking aortic aneurysm * Acute MI before peak troponin has been reached * Absent lower limbs * Pregnancy * Unstable fractures contributing to likely immobility * Hospitalization prior to ICU admission \>5 days * Enrollment in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average achieved SOMS level | Average SOMS level from time to inclusion to ICU discharge readiness, an expected time of one to two weeks (expected time of one to two weeks). | Achieved SOMS level will be assessed daily and average values be taken for comparison between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The mini modified Functional Independence Measure (mmFIM) level | mmFIM will be measured twice, at ICU discharge readiness and hospital discharge readiness, an expected average of one to two and three weeks, respectively. | Using the modified Functional Independence Measure (mmFIM), the levels of the locomotion and transfer mobility domain at hospital discharge (4 point NRS) will be compared between groups. |
| Quality of life following hospital discharge | three months after hospital discharge | SF 36 score |
| SICU length of stay | Patients will be followed until SICU discharge, an expected 2 days to 2 weeks | Time from study inclusion to SICU discharge readiness, an expected time of one to two weeks. |
| Side effects of mobilization therapy | during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks. | Number of unfavorable signs and symptoms or unintended deterioration of clinical status associated with mobilization therapy, including, but not limited to, unplanned extubation or dislodgment of drains, arterial catheters, venous devices, or other medical equipment. The relationship of any untoward event to mobilization therapy was assessed by the clinician and reported as unrelated, unlikely, possibly, or definitely related. AE were also categorized by intensity as mild, moderate, or severe |
| Genetic Polymorphisms as related to the other outcomes | 5 minutes to collect sample | Since Sleep duration has a genetic component corresponding to 40% heritability, we are going to conduct an analysis of known polymorphisms that are related to different variables of sleep quality and how it relates to muscle strength and mobility. In particular we will focus on polymorphisms in CLOCK, NPAS2, PER2 and PER3, PDE4D,MUC1, ATP2B1, DCDC5, TRPM6, SHROOM3, and MDS1 genes, which are associated with sleepiness, sleep phase, inertia, and potentially with respiratory muscle weakness and duration. |
| Muscle strength | ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively. | Medical Research Council (MRC) scale. |
Countries
Austria, Germany, United States
Outcome results
None listed