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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| University of Massachusetts, Worcester | OTHER |
| Technical University of Munich | OTHER |
| University of Salzburg |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Group will undergo usual mobilization per standard SICU care | |
| Study Group | Experimental | Patient mobilization discussed on rounds, SOMS score goal created, specific attempt to mobilize patient and achieve goal throughout day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOMS | Procedure | Apply a number to mobilization goal for patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average achieved SOMS level | Achieved SOMS level will be assessed daily and average values be taken for comparison between groups. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| SICU length of stay | Time from study inclusion to SICU discharge readiness, an expected time of one to two weeks. | Patients will be followed until SICU discharge, an expected 2 days to 2 weeks |
| The "mini" modified Functional Independence Measure (mmFIM) level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Eikermann, MD, PhD | The Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22067629 | Background | Kasotakis G, Schmidt U, Perry D, Grosse-Sundrup M, Benjamin J, Ryan C, Tully S, Hirschberg R, Waak K, Velmahos G, Bittner EA, Zafonte R, Cobb JP, Eikermann M. The surgical intensive care unit optimal mobility score predicts mortality and length of stay. Crit Care Med. 2012 Apr;40(4):1122-8. doi: 10.1097/CCM.0b013e3182376e6d. | |
| 27707496 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 24, 2017 | |
| Reset | May 5, 2017 | |
| Release | May 19, 2017 | |
| Reset | Dec 14, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 24, 2017 | May 5, 2017 | |||
| May 19, 2017 |
| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| D016638 | Critical Illness |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D004434 | Early Ambulation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| OTHER |
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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. |
| mmFIM will be measured twice, at ICU discharge readiness and hospital discharge readiness, an expected average of one to two and three weeks, respectively. |
| Quality of life following hospital discharge | SF 36 score | three months after hospital discharge |
| Muscle strength | Medical Research Council (MRC) scale. | ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively. |
| Side effects of mobilization therapy | 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 | during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks. |
| Genetic Polymorphisms as related to the other outcomes | 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. | 5 minutes to collect sample |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| University of Massachusetts | Worcester | Massachusetts | 01605 | United States |
| University of Salzburg | Salzburg | A-5020 | Austria |
| Technische Universität München | München | Bavaria | D-81675 | Germany |
| Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3. |
| 23959756 | Derived | Meyer MJ, Stanislaus AB, Lee J, Waak K, Ryan C, Saxena R, Ball S, Schmidt U, Poon T, Piva S, Walz M, Talmor DS, Blobner M, Latronico N, Eikermann M. Surgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patients. BMJ Open. 2013 Aug 19;3(8):e003262. doi: 10.1136/bmjopen-2013-003262. |
| Dec 14, 2017 |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D020969 | Disease Attributes |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D013812 |
| Therapeutics |