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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Ventilator Associated
• Intervention / Treatment: Device: kinetic therapy bed; Other: Manual turn

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: kinetic therapy bed; Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation; Other Names: CLRT (continuous lateral rotation therapy); KT (kinetic therapy)
Active Comparator: 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	Other: Manual turn; Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation; Other Names: Lateral rotation

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Society of Critical Care Medicine
• Investigators: Principal Investigator: Sandra K. Hanneman, PhD, RN, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• Padhye NS, Cron SG, Gusick GM, Hamlin SK, Hanneman SK. Randomization for clinical research: an easy-to-use spreadsheet method. Res Nurs Health. 2009 Oct;32(5):561-6. doi: 10.1002/nur.20341.
• Hamlin SK, Hanneman SK, Wachtel S, Gusick G. Adverse hemodynamic effects of lateral rotation during mechanical ventilation. Dimens Crit Care Nurs. 2008 Mar-Apr;27(2):54-61. doi: 10.1097/01.dcc.0000311593.87097.6a.
• Padhye NS, Hamlin S, Brazdeikis A, Hanneman SK. Cardiovascular impact of manual and automated turns in ICU. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:1844-7. doi: 10.1109/IEMBS.2009.5332599.
• Hanneman SK, Gusick GM, Hamlin SK, Wachtel SJ, Cron SG, Jones DJ, Oldham SA. Manual vs automated lateral rotation to reduce preventable pulmonary complications in ventilator patients. Am J Crit Care. 2015 Jan;24(1):24-32. doi: 10.4037/ajcc2015171.
• Hamlin SK, Hanneman SK, Padhye NS, Lodato RF. Hemodynamic changes with manual and automated lateral turning in patients receiving mechanical ventilation. Am J Crit Care. 2015 Mar;24(2):131-40. doi: 10.4037/ajcc2015782.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: October 9, 2007
• First Submitted That Met QC Criteria: October 9, 2007
• First Posted (Estimate): October 11, 2007

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: mechanical ventilation; pulmonary complications; lateral rotation; kinetic therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: TMCSCCMAACN