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Frequently Asked Questions Guide
For the RotoProne® Therapy System
 
 
Introducing the RotoProne® Therapy System


Two Important Therapies. One Innovative System.

The
RotoProne® Therapy System can help improve patient outcomes by delivering the benefits of Prone Therapy along with Kinetic Therapy™ in an easier-to-use automated system.

Prone Therapy
Prone therapy has been shown to improve outcomes in patients with pulmonary complications and may improve mortality among high risk patients.1

How It Works:

The Mechanism of Prone Therapy
Studies have shown that placing patients in the prone position may help:

  • Facilitate drainage of pulmonary secretions2
  • Decrease pleural pressure in the dependent portions of the lung3
  • Eliminate compression of the lungs by the heart4
  • Restore ventilation to dorsal lung regions without compromising ventral regions4
  • Improve ventilation and perfusion matching5

The Benefits:

Prone Therapy Patient Outcomes
Clinical studies have documented the effectiveness of Prone Therapy:

  • Improved 10-day survival rate among high-risk patients1
  • Sustained improvement in arterial oxygenation in ARDS patients6

Why It’s Underutilized:

Challenges Associated With Prone Therapy
There are several reasons why
Prone Therapy is not used, despite its clinical advantages:

  • Manual positioning is labor-intensive7 8 9
  • Risk management concerns for both patient and caregiver10
  • Additional caregiver time and costs9
  • Potential for tube entanglement or separation7 8 9 10

Kinetic Therapy™
By rotating patients bilaterally to 40° or more,
Kinetic Therapy™ has been clinically proven in more than 50 published studies to help:

  • Reduce ICU-acquired pneumonia by up to 50%11
  • Reduce lower respiratory tract infections by up to 32%12
  • Reduce ventilation time by up to 42%12
  • Reduce ICU length of stay by up to 24%11

Simplified Proning
The RotoProne® Therapy System automates the proning process:

  • Automated proning may help address caregiver risk management concerns
  • Minimal staff is required to prone patient
  • Touch-screen controls automatically control therapy system
  • Separate hand control allows caregiver to monitor patient lines and tubes during rotation
  • Tube management system helps secure patient lines during rotation

RotoProne® Therapy System Outcomes
Use of the combination of Prone Therapy and Kinetic Therapy™ in the
RotoProne® Therapy System* has shown the following benefits in a clinical trial13:

  • Significant improvement in oxygenation in all patients
  • Significant reduction in Severity of Organ Failure Assessment (SOFA) score
  • Easier nursing of severly injured multiple trauma patients

* Study using a non-commercial version of RotoProne® Therapy System.

RotoProne® Financial Guarantee
When your patient is treated with the RotoProne® Therapy System and no improvement (as defined in #4 below) is demonstrated within 96 hours, KCI agrees to share the financial risk associated with treating pulmonary complications by providing the bed placement for that patient at no charge.  This guarantee is subject to the following criteria and protocol:

  1. Place the patient on the RotoProne® Therapy System within 24 hours of his or her pulmonary status reaching the following definition criteria for ARDS:14
    • Acute onset
    • PaO2/FiO2 < 200mmHg (regardless of PEEP)
    • Bilateral pulmonary infiltrates on chest radiograph
    • Pulmonary artery wedge pressure < 18mmHg with no clinical evidence of left atrial hypertension
  2. Prone and rotate the patient at least 40° bilaterally for at least 18 hours per day.
  3. Adhere to all published KCI product instructions for use, operations manuals, protocols, system labels and onscreen guides.
  4. If the patient shows NO improvement in oxygenation (increased PaO2/FiO2 ratio), in blood gases or in chest radiograph within the first 96 hours of treatment, AND the facility notifies KCI prior to discontinuing the therapy, KCI will issue the bed placement for that patient at no charge to the institution.

RotoProne® Financial Guarantee is subject to compliance with guidance and restrictions listed in KCI’s guarantee program and is subject to change at any time without notice.  Programs are intended as financial risk sharing guarantees as they are specifically related to the cost of KCI product rental.  KCI makes no representation or warranty as to patient outcomes, healing incidental or consequential costs associated with patient treatment or hospitalization.  Therapy and product indications, contraindications, and warnings and precautions must be adhered to.  Individual results may vary.

1 Gattinoni, L, Tognoni G, Pesenti A, Taccone P, Mascheroni D, Labarta V, Malacrida R, Di Giulio P, Fumagalli R, Pelosi P, Brazzi L, Latini R, Effect of Prone Position on the Survival of Patients with Acute Respiratory Failure, The New England Journal of Medicine, 2001; 345: 568-573.
2 Pelosi P., Brazzi L., Gattinoni L. Prone Position in Acute Respiratory Distress Syndrome. European Respiratory Journal. 2002 Oct; 20 (4): 1017-1028.
3 Mutoh T, Guest RJ, Lamm W, Albert RK.  Prone Position Alters the Effect of Volume Overload on Regional Pleural Pressures and Improves Hypoxemia in Pigs in Vivo. Am. Rev. Respir. Dis. 1992; 146: 330-306.
4 Albert R, Hubmayr R. The Prone Position Eliminates Compression of the Lungs by the Heart. American Journal Respiratory Critical Care Medicine, 2000; 161: 1660-1665.
5 Pappert D, Rossaint R, Slama K et al. Influence of Positioning on Ventilation – Perfusion Relationships in Severe Adult Respiratory Distress Syndrome. Chest, 1994; 106: 1511-1516.
6 Lee D.L. Prone-Position Ventilation Induces Sustained Improvement in Oxygenation in Patients with Acute Respiratory Distress Syndrome Who Have a Large Shunt. Critical Care Medicine. 2002 July; 30(7):1446-1452.
7 Ball C.  Use of the Prone Position in the Management of Acute Respiratory Distress Syndrome. Intensive and Critical Care Nursing 2001; 15: 192-203.
8 Rowe, C. Development of Clinical Guidelines for Prone Positioning in Critically Ill Adults. Nursing in Critical Care 2004; 9:50-57.
9 McCormick J. and Blackwood B.  Nursing the ARDS Patient in the Prone Position; the Experience of Qualified ICU Nurses. Intensive and Critical Care Nursing 2001; 17: 331-340.
10 Gosheron M, Leaver G, Forester A, et al. Prone Lyinig – a Nursing Perspective. Care of Critically Ill 1998; 14: 89-92.
11 Choi S.C, Nelson LD. Kinetic Therapy™ in Critically Ill Patients: Combined Results Based on Meta-Analysis. Journal of Critical Care, 1992; 7: 57-62.
12 Fink, M.P., MD; Helsmoortel, C.M., RN, et al. The Efficacy of an Oscillating Bed in the Prevention of Lower Respiratory Tract Infection in Critically Ill Victims of Blunt Trauma. Chest, 1992; Vol. 97, 132-137.
13 Stiletto, R. J., MD et al. Computer-Supported Continuous Axial Rotation Therapy in Prone Position For Complex Polytrauma Patients With ARDS. Abstract presented at ACCP-Chest Meeting, 2001). Full study
14 Bernard, G.R., et al: The American European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. The American Journal of Respiratory Care Medicine. 1994; 149 (3pt1): 819.