Mobility Limitations Clinical Trial
— EMSOfficial title:
Effects of Mobility Devices on Nursing Compliance With Mobility Protocols.
NCT number | NCT01690910 |
Other study ID # | RCAY 40 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | March 2013 |
Verified date | March 2021 |
Source | Saint Joseph Mercy Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a 10-week pilot study for a randomized non-blinded controlled clinical trial to assess whether use of the Rifton Gait Trainer will improve the incidence of mobilization of critically ill ventilator dependent patients in the intensive care units (ICUs) and improve important patient outcomes. The pilot study is designed to assess the feasibility and logistics of doing a study of this nature in the ICU; it will also provide the means to obtain estimates of outcome effect sizes, number of repeated measures, time between repeated measures, and intra-subject and intra-unit correlations, to be used for sample size calculations.
Status | Terminated |
Enrollment | 3 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - >18 years of age - On the ventilator for > 48 hours - Mobility score > 3 Exclusion Criteria: - > 220 lbs - Limb amputees - Prisoners - Pregnant women |
Country | Name | City | State |
---|---|---|---|
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
Saint Joseph Mercy Health System |
United States,
Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, Veale K, Rodriquez L, Hopkins RO. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007 Jan;35(1):139-45. — View Citation
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Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. — View Citation
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Needham DM, Wang W, Desai SV, Mendez-Tellez PA, Dennison CR, Sevransky J, Shanholtz C, Ciesla N, Spillman K, Pronovost PJ. Intensive care unit exposures for long-term outcomes research: development and description of exposures for 150 patients with acute lung injury. J Crit Care. 2007 Dec;22(4):275-84. Epub 2007 Jun 27. — View Citation
Needham DM. Mobilizing patients in the intensive care unit: improving neuromuscular weakness and physical function. JAMA. 2008 Oct 8;300(14):1685-90. doi: 10.1001/jama.300.14.1685. — View Citation
Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Number of Times the Critically Ill Ventilator Dependent Patient is Mobilized. | Duration of Intensive Care Unit Stay (2-30 days) | ||
Secondary | Length of Time the Critically Ill Ventilator Dependent Patient is Mobilized. | Patient weight baring to patient seated (1-12 minutes) |
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