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

Pneumonia, Ventilator Associated Clinical Trial

Official title:

Multi-site Randomized Clinical Trial of Horizontal Positioning to Prevent and Treat Pulmonary Complications in Mechanically Ventilated Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542321
• Other study ID #: TMCSCCMAACN
• Status: Completed
• Phase: N/A
• First received: October 9, 2007
• Last updated: June 18, 2013
• Start date: September 2007
• Est. completion date: September 2011

Study information

• Verified date: June 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia, Ventilator Associated
• Pneumonia, Ventilator-Associated

Intervention

Other:
• Manual turn
Manual turn 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Society of Critical Care Medicine

References & Publications (3)

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. Review. — View 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. — View Citation

Padhye NS, Hamlin S, Brazdeikis A, Hanneman SK. Cardiovascular impact of manual and automated turns in ICU. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:1844-7. doi: 10.1109/IEMBS.2009.5332599. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants were followed for the duration of ICU stay, an average of 10 days.	No
Secondary	Mechanical Ventilation Duration.	Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation	Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.	No
Secondary	ICU Length of Stay.	Time in days from study ICU admission to study ICU discharge or death	Participants were followed for the duration of ICU stay, an average of 10 days.	No
Secondary	ICU All-cause Mortality.	Death from any reason between admission and discharge from study ICU	Participants were followed for the duration of ICU stay, an average of 10 days.	No
Secondary	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	Participants were followed for the duration of time on protocol, an average of 3.5 days.	Yes