Holy Name Progressive Mobility in the ICU
A Clinical Study Of The Impact Of Total Care® Bed System Combined With The Liko Lift to Facilitate Early Progressive Mobility Compliance and Associated Clinical and Financial Outcomes.
1 other identifier
observational
63
1 country
1
Brief Summary
Despite the known complications of immobility for ICU patients, compliance to mobility protocols is lacking in many institutions. Significant barriers have been described to compliance to up in chair and weight bearing orders in the ICU. Recent studies indicate that if progressive mobility is performed for acutely ill ICU patients they may have a reduced ICU length of stay, reduced overall hospital length of stay, incur lower hospital costs, and reduce the rate of some medical complications and increase functionality post ICU discharge. The current protocol seeks to understand whether or not the TotalCare® P500 Bed System and the Liko Lift can remove some of the barriers associated with progressive mobility compliance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 27, 2015
CompletedAugust 27, 2015
August 1, 2015
1.8 years
March 22, 2012
August 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
First out of bed, which is to be defined as the first time that a patient stands whether assisted or not for > 1 minute.
at ICU discharge (current avg LOS = 6 days)
Secondary Outcomes (7)
ICU length of stay
at ICU discharge (current avg LOS = 6 days)
Days of Mechanical Ventilation assessed as time to extubation. Extubation is to be defined as the time when the ET tube is removed from the airway
at ICU discharge (current avg LOS = 6 days)
Compliance with, Number and Duration of Up in Chair episodes. Patients will be considered compliant if they complete 100% of prescribed episodes.
at ICU discharge (current avg LOS = 6 days)
ICU readmission rate (within 30 days)
at ICU discharge (current avg LOS = 6 days)
Incidence of nosocomial pressure ulcers and change in existing pressure ulcers
at ICU discharge (current avg LOS = 6 days)
- +2 more secondary outcomes
Study Arms (2)
Standard of care
Patients admitted to the ICU will receive current standard of care related to mobility
Progressive mobility
patients admitted to the ICU will receive mobility per Progressive Mobility protocol using TotalCare beds and lifts
Eligibility Criteria
Adult patients admitted to the Medical ICU
You may qualify if:
- Patient is ≥ 18 years old.
- Patient has been admitted to the ICU for less than 3 days prior to study enrollment
- Patients require mechanical ventilation for \> 48 hours
You may not qualify if:
- Patient has an unstable spinal injury.
- Patient weighs less than 70 pounds or more than 450 pounds
- Mobilization is contraindicated by Patient's condition. Such as hip fractures or other injury that would impede standing posture.
- Patient was unable to walk without assistance prior to ICU admission.
- Patient was cognitively impaired prior to ICU admission.
- Patient has experienced acute stroke with neurologic impairment
- Patient's primary diagnosis is drug overdose.
- Patient has Comfort Care Measures/End of Life orders and/or is at an end stage terminal disease state.
- Patient requires a bed other than the standard care bed for any reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hill-Romlead
Study Sites (1)
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary J Tracy, RN, MSN
Holy Name Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2012
First Posted
August 27, 2015
Study Start
January 1, 2011
Primary Completion
November 1, 2012
Study Completion
January 1, 2013
Last Updated
August 27, 2015
Record last verified: 2015-08