Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients

Critical Illness Clinical Trial

— mSOMS  

Official title:

Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01363102
• Other study ID #: 11112010
• Status: Active, not recruiting
• Phase: N/A
• First received: May 23, 2011
• Last updated: March 16, 2016
• Start date: June 2011
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Muscle Weakness
• Paresis
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Procedure:
• SOMS
Apply a number to mobilization goal for patient

Locations

Country	Name	City	State
Austria	University of Salzburg	Salzburg
Germany	Technische Universität München	München	Bavaria
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	The Massachusetts General Hospital	Boston	Massachusetts
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center, Technische Universität München, University of Massachusetts, Worcester, University of Salzburg

Countries where clinical trial is conducted

United States,  Austria,  Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Secondary	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
Secondary	The "mini" modified Functional Independence Measure (mmFIM) level	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.
Secondary	Quality of life following hospital discharge	SF 36 score	three months after hospital discharge
Secondary	Muscle strength	Medical Research Council (MRC) scale.	ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively.
Secondary	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.
Secondary	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