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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pneumonia, Ventilator Associated

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Kinetic Therapy Bed

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

Group Type EXPERIMENTAL

kinetic therapy bed

Intervention Type DEVICE

Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation

Manual Turn

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

Group Type ACTIVE_COMPARATOR

Manual turn

Intervention Type OTHER

Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation

Interventions

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Manual turn

Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation

Intervention Type OTHER

kinetic therapy bed

Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation

Intervention Type DEVICE

Other Intervention Names

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Lateral rotation CLRT (continuous lateral rotation therapy) KT (kinetic therapy)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No