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

This study has been completed.
Sponsor:
Collaborator:
Society of Critical Care Medicine
Information provided by (Responsible Party):
Sandra K. Hanneman, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00542321
First received: October 9, 2007
Last updated: June 18, 2013
Last verified: June 2013

October 9, 2007
June 18, 2013
September 2007
September 2011   (final data collection date for primary outcome measure)
Incidence of Pulmonary Complications. [ Time Frame: Participants were followed for the duration of ICU stay, an average of 10 days. ] [ Designated as safety issue: No ]
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.
Incidence of pulmonary complications. Time to development and time to resolution of pulmonary complications
Complete list of historical versions of study NCT00542321 on ClinicalTrials.gov Archive Site
  • Mechanical Ventilation Duration. [ Time Frame: Participants were followed for the duration of mechanical ventilation, an average of 5.5 days. ] [ Designated as safety issue: No ]
    Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation
  • ICU Length of Stay. [ Time Frame: Participants were followed for the duration of ICU stay, an average of 10 days. ] [ Designated as safety issue: No ]
    Time in days from study ICU admission to study ICU discharge or death
  • ICU All-cause Mortality. [ Time Frame: Participants were followed for the duration of ICU stay, an average of 10 days. ] [ Designated as safety issue: No ]
    Death from any reason between admission and discharge from study ICU
  • Turning-related Events [ Time Frame: Participants were followed for the duration of time on protocol, an average of 3.5 days. ] [ Designated as safety issue: Yes ]
    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
Mechanical ventilation duration; ICU length of stay; ICU all-cause mortality; turning-related adverse events
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pneumonia, Ventilator Associated
  • Other: Manual turn
    Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation
    Other Name: Lateral rotation
  • 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)
  • 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
    Intervention: Device: kinetic therapy bed
  • 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
    Intervention: Other: Manual turn

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00542321
TMCSCCMAACN
Yes
Sandra K. Hanneman, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Society of Critical Care Medicine
Principal Investigator: Sandra K. Hanneman, PhD, RN The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP