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

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Kinetic Therapy Bed	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
Manual Turn	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

Primary Outcome Measures

Name	Time	Method
Incidence of Pulmonary Complications.	Participants were followed for the duration of ICU stay, an average of 10 days.	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.

Secondary Outcome Measures

Name	Time	Method
ICU Length of Stay.	Participants were followed for the duration of ICU stay, an average of 10 days.	Time in days from study ICU admission to study ICU discharge or death
Mechanical Ventilation Duration.	Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.	Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation
ICU All-cause Mortality.	Participants were followed for the duration of ICU stay, an average of 10 days.	Death from any reason between admission and discharge from study ICU
Turning-related Events	Participants were followed for the duration of time on protocol, an average of 3.5 days.	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