Pilot Study of Lateral Rotation Interventions for Efficacy and Safety in ICU Care
March 8, 2016 updated by: Sandra K. Hanneman, The University of Texas Health Science Center, Houston
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
Intervention / Treatment
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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
|
Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation
Other Names:
|
|
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
|
Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Pulmonary Complications.
Time Frame: 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.
|
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.
Time Frame: 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
|
Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.
|
|
ICU Length of Stay.
Time Frame: 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
|
Participants were followed for the duration of ICU stay, an average of 10 days.
|
|
ICU All-cause Mortality.
Time Frame: 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
|
Participants were followed for the duration of ICU stay, an average of 10 days.
|
|
Turning-related Events
Time Frame: 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
|
Participants were followed for the duration of time on protocol, an average of 3.5 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sandra K. Hanneman, PhD, RN, The University of Texas Health Science Center, Houston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMCSCCMAACN
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