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

The University of Texas System (UT)

Status: Completed

Conditions: Pneumonia, Ventilator Associated

Treatments: Other: Manual turn; Device: kinetic therapy bed

Study type: Interventional

Funder types: Other

Identifiers

NCT00542321

TMCSCCMAACN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• receiving mechanical ventilation
• ability to place on study protocol within 8 hours of intubation

Exclusion criteria

• pulmonary mass, pneumothorax, hemothorax, pleural effusion, or other source of compression atelectasis at time of assessment for eligibility
• systolic blood pressure < 90 mmHg with vasopressor support
• orthopedic injuries requiring limited or complete immobilization
• head injury requiring intracranial pressure monitoring
• unstable spinal injuries
• rib fractures
• body weight > 350 lbs
• intubation within the previous 2 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Kinetic Therapy Bed

Experimental group

Description:

Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days

Treatment:

Device: kinetic therapy bed

Manual Turn

Active Comparator group

Description:

Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with \>/= 45 degree lateral rotation angle and 30 degree head of bed elevation

Treatment:

Other: Manual turn