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
  Purpose

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.


Condition Intervention
Pneumonia, Ventilator Associated
Other: Manual turn
Device: kinetic therapy bed

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-site Randomized Clinical Trial of Horizontal Positioning to Prevent and Treat Pulmonary Complications in Mechanically Ventilated Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: September 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lateral rotation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542321

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

Publications:
Responsible Party: Sandra K. Hanneman, Professor - UT School of Nursing, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00542321     History of Changes
Other Study ID Numbers: TMCSCCMAACN
Study First Received: October 9, 2007
Results First Received: October 2, 2012
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
lateral rotation
kinetic therapy
mechanical ventilation
pulmonary complications

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Cross Infection
Infection
Lung Diseases
Lung Injury
Pneumonia
Respiratory Tract Diseases
Respiratory Tract Infections
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on October 20, 2014