Pilot Study of Lateral Rotation Interventions for Efficacy and Safety in ICU Care - Full Text View

Sponsors and Collaborators:	The University of Texas Health Science Center, Houston Society of Critical Care Medicine
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00542321

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 II Phase III

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multi-Site Randomized Clinical Trial of Horizontal Positioning to Prevent and Treat Pulmonary Complications in Mechanically Ventilated Critically Ill Patients

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 ]

Estimated Enrollment:	20
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (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 Device: kinetic therapy bed Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation

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

Contacts

Contact: Sandra K Hanneman, PhD, RN

(713) 500-2030

Sandra.K.Hanneman@uth.tmc.edu

Locations

United States, Texas
St. Luke's Episcopal Hospital	Recruiting
Houston, Texas, United States, 77030

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

Responsible Party:	University of Texas Health Science Center at Houston ( Sandra K. Hanneman, Prinicipal Investigator )
Study ID Numbers:	TMCSCCMAACN
Study First Received:	October 9, 2007
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00542321
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

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Critical Illness
Lung Diseases

Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 15, 2009