NCT00542321

Pilot Study of Lateral Rotation Interventions for Efficacy and Safety in ICU Care

Multi-site Randomized Clinical Trial of Horizontal Positioning to Prevent and Treat Pulmonary Complications in Mechanically Ventilated Critically Ill Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pneumonia, Ventilator Associated

Interventions

Type	Name	Description
OTHER	Manual turn	Manual turn 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

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2007-10-11
• Last updated: 2016-04-06
• Results posted: 2013-07-24