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Sponsors and Collaborators: |
The University of Texas Health Science Center, Houston Society of Critical Care Medicine |
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Information provided by: | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00542321 |
Intensive care unit (ICU) patients on respirators are at high risk for preventable pulmonary complications (PPC). Turning these patients from side to side may reduce PPC, but carries the burden of decreases in blood pressure and oxygenation. The investigators hypothesize that there will be no difference in PPC or adverse events when ICU patients on respirators are turned by nurses or by an automated turning bed.
Condition | Intervention | Phase |
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Pneumonia, Ventilator Associated |
Other: Manual turning Device: kinetic therapy bed |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multi-Site Randomized Clinical Trial of Horizontal Positioning to Prevent and Treat Pulmonary Complications in Mechanically Ventilated Critically Ill Patients |
Estimated Enrollment: | 20 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Experimental: Experimental
Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more
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Other: Manual turning
Manual turning from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation
Device: kinetic therapy bed
Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation
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The purpose of this pilot study is to test the feasibility of two turning protocols and study procedures for a multi-site randomized clinical trial to evaluate efficacy and safety of horizontal positioning interventions to reduce pulmonary complications in mechanically ventilated critically ill adult patients. The hypothesis of the randomized controlled trial (RCT) is no difference in pulmonary complications between manual, 2-hourly lateral rotation to > 45 degrees (control), and continuous automated turning to 45 degrees (experimental) groups.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sandra K Hanneman, PhD, RN | (713) 500-2030 | Sandra.K.Hanneman@uth.tmc.edu |
United States, Texas | |
St. Luke's Episcopal Hospital | Recruiting |
Houston, Texas, United States, 77030 |
Principal Investigator: | Sandra K. Hanneman, PhD, RN | The University of Texas Health Science Center, Houston |
Responsible Party: | University of Texas Health Science Center at Houston ( Sandra K. Hanneman, Prinicipal Investigator ) |
Study ID Numbers: | TMCSCCMAACN |
Study First Received: | October 9, 2007 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00542321 |
Health Authority: | United States: Institutional Review Board |
lateral rotation kinetic therapy mechanical ventilation pulmonary complications |
Respiratory Tract Infections Respiratory Tract Diseases Critical Illness Lung Diseases |
Pneumonia, Ventilator-Associated Cross Infection Pneumonia |
Infection |