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

Study Overview
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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.

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.

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

Conditions
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Pneumonia, Ventilator Associated

Intervention / Treatment
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* Other: Manual turn
* Device: kinetic therapy bed


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinetic Therapy Bed<br>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 | Device: kinetic therapy bed<br>* Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation<br>* Other names: KT (kinetic therapy);|
| Active Comparator: Manual Turn<br>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 | Other: Manual turn<br>* Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation<br>* Other names: Lateral rotation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Pulmonary Complications. | Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups. | Participants were followed for the duration of ICU stay, an average of 10 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical Ventilation Duration. | Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation | Participants were followed for the duration of mechanical ventilation, an average of 5.5 days. | 
| ICU Length of Stay. | Time in days from study ICU admission to study ICU discharge or death | Participants were followed for the duration of ICU stay, an average of 10 days. | 
| ICU All-cause Mortality. | Death from any reason between admission and discharge from study ICU | Participants were followed for the duration of ICU stay, an average of 10 days. | 
| Turning-related Events | Non-serious adverse events that occurred during the time of rotation in the kinetic therapy bed group and during lateral rotation to right or left position in the manual turn group | Participants were followed for the duration of time on protocol, an average of 3.5 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lateral rotation, kinetic therapy, mechanical ventilation, pulmonary complications