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

NCT00542321 | Completed Results DMC

• 1 other identifier: TMCSCCMAACN
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumonia, Ventilator Associated

Keywords

lateral rotation; kinetic therapy; mechanical ventilation; pulmonary complications

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Mechanical Ventilation Duration.

  Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.

• ICU Length of Stay.

  Participants were followed for the duration of ICU stay, an average of 10 days.

• ICU All-cause Mortality.

  Participants were followed for the duration of ICU stay, an average of 10 days.

• Turning-related Events

  Participants were followed for the duration of time on protocol, an average of 3.5 days.

Study Arms (2)

Kinetic Therapy Bed

EXPERIMENTAL

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

Manual Turn

ACTIVE COMPARATOR

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

Interventions

Manual turn OTHER

Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation

Also known as: Lateral rotation

Manual Turn

kinetic therapy bed DEVICE

Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation

Also known as: CLRT (continuous lateral rotation therapy), KT (kinetic therapy)

Kinetic Therapy Bed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• receiving mechanical ventilation
• ability to place on study protocol within 8 hours of intubation

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Society of Critical Care Medicine: collaborator

Related Publications (5)

• 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.

  PMID: 19606450 BACKGROUND

• 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.

  PMID: 18510182 BACKGROUND

• 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.

  PMID: 19963521 BACKGROUND

• 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.

  PMID: 25554551 BACKGROUND

• 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.

  PMID: 25727273 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Reliance on chest X-ray interpretation only for detection of preventable pulmonary complications; small pilot study; kinetic therapy bed turn angle was less than 45 degrees

Results Point of Contact

• Title: Sandra K. Hanneman, PhD, RN, FAAN
• Organization: University of Texas Health Science Center at Houston

Sandra.K.Hanneman@uth.tmc.edu

713-500-2030

Study Officials

• Sandra K. Hanneman, PhD, RN

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - UT School of Nursing

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 11, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 6, 2016
• Results First Posted: July 24, 2013

Record last verified: 2016-03