Clinical trial NCT00542321: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Ventilator Associated
Keywords: lateral rotation
kinetic therapy
mechanical ventilation
pulmonary complications
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Society of Critical Care Medicine
First posted: 2007-10-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Pulmonary Complications.
timeFrame: Participants were followed for the duration of ICU stay, an average of 10 days.
Secondary outcomes:
measure: Mechanical Ventilation Duration.
timeFrame: Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.
measure: ICU Length of Stay.
timeFrame: Participants were followed for the duration of ICU stay, an average of 10 days.
measure: ICU All-cause Mortality.
timeFrame: Participants were followed for the duration of ICU stay, an average of 10 days.
measure: Turning-related Events
timeFrame: Participants were followed for the duration of time on protocol, an average of 3.5 days.
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sandra K. Hanneman, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.