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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: March 15, 2012
Last verified: March 2012
History of Changes
  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 Phase
Pneumonia, Ventilator Associated
 Other: Manual turning
Device: kinetic therapy bed
 Phase 2
Phase 3

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:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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

Primary Outcome Measures:
  • Incidence of pulmonary complications. [ Time Frame: After study participation has been completed ] [ Designated as safety issue: No ]
  • Time to development and time to resolution of pulmonary complications. [ Time Frame: After study participation has been completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mechanical ventilation duration. [ Time Frame: After study participation has been completed ] [ Designated as safety issue: Yes ]
  • ICU length of stay. [ Time Frame: After study participation has been completed ] [ Designated as safety issue: Yes ]
  • ICU all-cause mortality. [ Time Frame: After study participation has been completed ] [ Designated as safety issue: Yes ]
  • Turning-related adverse events. [ Time Frame: After study participation has been completed ] [ Designated as safety issue: Yes ]

Enrollment: 35
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: Experimental
Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more
 Other: Manual turning
Manual turning 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)

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
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
Last Updated: March 15, 2012
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
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on June 13, 2013