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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
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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
    background
    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
    background

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

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