- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295541
Early Progressive Mobility in the CVICU: Assessing Current Status
February 11, 2011 updated by: Hill-Rom
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Macon, Georgia, United States, 31201
- Medical College of Central Georgia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population will consist of patients admitted to the CV-Intensive Care Unit.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
4 months of observation
CVICU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
First OOB
Time Frame: Days
|
The ICU day that the patient is able to stand for at least 1 minute will be assessed.
|
Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU LOS
Time Frame: Days
|
Length of stay will be measured
|
Days
|
Type and Frequency of PM orders
Time Frame: Daily
|
The type and frequency of Progressive mobility orders will be assessed
|
Daily
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leslie Culpepper, MSN, RN, The Medical Cneter of Central Georgia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (ACTUAL)
December 1, 2010
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
July 6, 2010
First Submitted That Met QC Criteria
February 11, 2011
First Posted (ESTIMATE)
February 14, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
February 14, 2011
Last Update Submitted That Met QC Criteria
February 11, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR-2009-05a
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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