Pilot Study of Lateral Rotation Interventions for Efficacy and Safety in ICU Care
Primary Purpose
Pneumonia, Ventilator Associated
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual turn
kinetic therapy bed
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Ventilator Associated focused on measuring lateral rotation, kinetic therapy, mechanical ventilation, pulmonary complications
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Kinetic Therapy Bed
Manual Turn
Arm Description
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: 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mechanical Ventilation Duration.
Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation
ICU Length of Stay.
Time in days from study ICU admission to study ICU discharge or death
ICU All-cause Mortality.
Death from any reason between admission and discharge from study ICU
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
Full Information
NCT ID
NCT00542321
First Posted
October 9, 2007
Last Updated
March 8, 2016
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Society of Critical Care Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00542321
Brief Title
Pilot Study of Lateral Rotation Interventions for Efficacy and Safety in ICU Care
Official Title
Multi-site Randomized Clinical Trial of Horizontal Positioning to Prevent and Treat Pulmonary Complications in Mechanically Ventilated Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Society of Critical Care Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilator Associated
Keywords
lateral rotation, kinetic therapy, mechanical ventilation, pulmonary complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kinetic Therapy Bed
Arm Type
Experimental
Arm Description
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
Arm Title
Manual Turn
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Manual turn
Other Intervention Name(s)
Lateral rotation
Intervention Description
Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation
Intervention Type
Device
Intervention Name(s)
kinetic therapy bed
Other Intervention Name(s)
CLRT (continuous lateral rotation therapy), KT (kinetic therapy)
Intervention Description
Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation
Primary Outcome Measure Information:
Title
Incidence of Pulmonary Complications.
Description
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.
Time Frame
Participants were followed for the duration of ICU stay, an average of 10 days.
Secondary Outcome Measure Information:
Title
Mechanical Ventilation Duration.
Description
Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation
Time Frame
Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.
Title
ICU Length of Stay.
Description
Time in days from study ICU admission to study ICU discharge or death
Time Frame
Participants were followed for the duration of ICU stay, an average of 10 days.
Title
ICU All-cause Mortality.
Description
Death from any reason between admission and discharge from study ICU
Time Frame
Participants were followed for the duration of ICU stay, an average of 10 days.
Title
Turning-related Events
Description
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
Time Frame
Participants were followed for the duration of time on protocol, an average of 3.5 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra K. Hanneman, PhD, RN
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19606450
Citation
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.
Results Reference
background
PubMed Identifier
18510182
Citation
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.
Results Reference
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PubMed Identifier
19963521
Citation
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.
Results Reference
background
PubMed Identifier
25554551
Citation
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.
Results Reference
background
PubMed Identifier
25727273
Citation
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.
Results Reference
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Pilot Study of Lateral Rotation Interventions for Efficacy and Safety in ICU Care
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