Early Progressive Mobility in the CVICU: Assessing Current Status

This study has been completed.
Sponsor:
Information provided by:
Hill-Rom
ClinicalTrials.gov Identifier:
NCT01295541
First received: July 6, 2010
Last updated: February 11, 2011
Last verified: February 2011

July 6, 2010
February 11, 2011
July 2010
December 2010   (final data collection date for primary outcome measure)
First OOB [ Time Frame: Days ] [ Designated as safety issue: No ]
The ICU day that the patient is able to stand for at least 1 minute will be assessed.
Same as current
Complete list of historical versions of study NCT01295541 on ClinicalTrials.gov Archive Site
  • ICU LOS [ Time Frame: Days ] [ Designated as safety issue: No ]
    Length of stay will be measured
  • Type and Frequency of PM orders [ Time Frame: Daily ] [ Designated as safety issue: No ]
    The type and frequency of Progressive mobility orders will be assessed
Same as current
Not Provided
Not Provided
 
Early Progressive Mobility in the CVICU: Assessing Current Status
Early Progressive Mobility in the CVICU: Assessing Current Status

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The study population will consist of patients admitted to the CV-Intensive Care Unit.

Immobility and Weakness Associated With Long Intensive Care Unit Stays
Not Provided
4 months of observation
CVICU
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01295541
CR-2009-05a
No
Catherine VanGilder, Hill-Rom
Hill-Rom
Not Provided
Principal Investigator: Leslie Culpepper, MSN, RN The Medical Cneter of Central Georgia
Hill-Rom
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP