Early Progressive Mobility in the CVICU: Assessing Current Status
| Tracking Information | |||||
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| First Received Date ICMJE | July 6, 2010 | ||||
| Last Updated Date | February 11, 2011 | ||||
| Start Date ICMJE | July 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01295541 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Progressive Mobility in the CVICU: Assessing Current Status | ||||
| Official Title ICMJE | Early Progressive Mobility in the CVICU: Assessing Current Status | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | The study population will consist of patients admitted to the CV-Intensive Care Unit. |
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| Condition ICMJE | Immobility and Weakness Associated With Long Intensive Care Unit Stays | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 4 months of observation
CVICU |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 10 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01295541 | ||||
| Other Study ID Numbers ICMJE | CR-2009-05a | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Catherine VanGilder, Hill-Rom | ||||
| Study Sponsor ICMJE | Hill-Rom | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hill-Rom | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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