Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients
This trial is active, not recruiting.
|Conditions||muscle weakness, critical illness, respiratory insufficiency|
|Sponsor||Massachusetts General Hospital|
|Collaborator||Beth Israel Deaconess Medical Center|
|Start date||June 2011|
|End date||July 2015|
|Trial size||200 participants|
|Trial identifier||NCT01363102, 11112010|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Boston, MA||The Massachusetts General Hospital||no longer recruiting|
|Boston, MA||Beth Israel Deaconess Medical Center||no longer recruiting|
|Worcester, MA||University of Massachusetts||no longer recruiting|
|Salzburg, Austria||University of Salzburg||no longer recruiting|
|München, Germany||Technische Universität München||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Average achieved SOMS level
time frame: 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).
SICU length of stay
time frame: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks
The "mini" modified Functional Independence Measure (mmFIM) level
time frame: 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
time frame: three months after hospital discharge
time frame: ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively.
Side effects of mobilization therapy
time frame: during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks.
Genetic Polymorphisms as related to the other outcomes
time frame: 5 minutes to collect sample
Male or female participants from 18 years up to 85 years old.
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
|Official title||Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients|
|Principal investigator||Matthias Eikermann, MD, PhD|
|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.|
Call for more information