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Early Progressive Mobility in the CVICU: Assessing Current Status

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295541
First Posted: February 14, 2011
Last Update Posted: February 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hill-Rom
  Purpose
The current study is proposed to assess the frequency and type of progressive mobility procedures currently performed in the CVICU The study will evaluate the type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing. Other outcome measures will be the days of required mechanical ventilation, and current ICU length of stay and cost to treat.

Condition
Immobility and Weakness Associated With Long Intensive Care Unit Stays

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Progressive Mobility in the CVICU: Assessing Current Status

Further study details as provided by Hill-Rom:

Primary Outcome Measures:
  • First OOB [ Time Frame: Days ]
    The ICU day that the patient is able to stand for at least 1 minute will be assessed.


Secondary Outcome Measures:
  • ICU LOS [ Time Frame: Days ]
    Length of stay will be measured

  • Type and Frequency of PM orders [ Time Frame: Daily ]
    The type and frequency of Progressive mobility orders will be assessed


Enrollment: 10
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
4 months of observation
CVICU

Detailed Description:
This will be a descriptive 4 month study of standard care practice. Patients who meet the inclusion / exclusion criteria for study will be enrolled (Waiver of informed consent is requested) and followed for a maximum of 28 days. The type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing will be recorded. Weight bearing will be defined as standing for at least 1 minute. ICU LOS, Ventilator Days will be assessed at ICU discharge for study patients. Barriers to PM procedures will also be assessed.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of patients admitted to the CV-Intensive Care Unit.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Mobilization is contraindicated by Patient's condition. Such as hip fractures or other injury that would impede standing posture.
  • Patient weighs less than 70 pounds or more than 440 pounds
  • Mobilization is contraindicated by patient's condition or physician's orders exist that prevent the patient from participating in the mobility protocol.
  • Patient was unable to walk or stand without assistance prior to ICU admission.
  • Patient was cognitively unable to follow verbal commands prior to ICU admission.
  • Patients current diagnosis includes acute stroke with neurologic impairment
  • Patient's current diagnosis includes drug overdose.
  • Patient has "Do not resuscitate" orders and/or is at an end stage terminal disease state.
  • Patient requires a specialty bed or mattress.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295541


Locations
United States, Georgia
Medical College of Central Georgia
Macon, Georgia, United States, 31201
Sponsors and Collaborators
Hill-Rom
Investigators
Principal Investigator: Leslie Culpepper, MSN, RN The Medical Cneter of Central Georgia
  More Information

Responsible Party: Catherine VanGilder, Hill-Rom
ClinicalTrials.gov Identifier: NCT01295541     History of Changes
Other Study ID Numbers: CR-2009-05a
First Submitted: July 6, 2010
First Posted: February 14, 2011
Last Update Posted: February 14, 2011
Last Verified: February 2011

Keywords provided by Hill-Rom:
ICU LOS
Progressive Mobility
Deconditioning