Project Description

Supported by:

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The PneuX pneumonia prevention system has been designed to prevent ventilator-associated pneumonia and works by preventing aspiration of bacteria laden subglottic secretions

Background

Ventilator-associated pneumonia (VAP) is the leading infective hospital acquired cause of mortality in the Intensive Care Unit (ICU).

If a patient develops VAP, it increases their length of stay in the ICU, increases their risk of mortality and has high cost implications for the NHS.1

Problem

VAP is caused by leakage of bacteria laden oral and gastric secretions past the endotracheal tube and into the patient’s lungs.2 Leakage of these secretions occurs in standard tubes because of the folds that form in the cuffs of endotracheal tubes inside the patient’s trachea.3

PneuX™

No folds in the PneuX™ ETT, no leakage of subglottic secretions (syringe represents the patient’s trachea)

Standard ETT

Folds form in the cuffs of standard ETT and allow leakage of subglottic secretion (syringe represents the patient’s trachea)

Solution

The PneuX™ prevents VAP by preventing aspiration of subglottic secretions into the lungs

Silicone cuff

The novel silicone cuff forms an effective seal without folds to prevent leakage of subglottic fluids

Subglottic ports

There are three internal subglottic ports to allow removal of subglottic secretions

The patient’s trachea can be irrigated with high volumes of normal saline to clean the subglottic space

Tracheal Seal Monitor

Inflates the cuff to the correct pressure for the patient’s trachea

Maintains the correct pressure at all times and rapidly compensates for tube movement

Training

Intubation and tube exchange using the PneuX endotracheal tube and tracheal seal monitor

Aspiration and irrigation using the PneuX™ endotracheal tube and tracheal seal monitor

Please ensure you have been fully trained by the company representatives before using the PneuX™ system in your hospital.

Clinical Evidence

The PneuX™ has been designed to prevent VAP 

Significant reduction in VAP when using the PneuX™ in cardiac surgical patients

This NHS study assessed the PneuX™ against standard endotracheal tubes in high risk patients undergoing cardiac surgery. Even during short intubation times, the incidence of pneumonia was significantly lower with the PneuX™ than with standard endotracheal tubes (P = 0.03).7 https://academic.oup.com/ejcts/article/47/3/e92/524144/Significant-reduction-in-ventilator-associated

Lower bacterial colonisation rates when the PneuX™ is used

In this study the bacterial colonisation rates of endotracheal tubes were assessed, comparing the PneuX™ to standard endotracheal tubes. Endotracheal tubes were in situ for 48 hours. After extubation, endotracheal tubes were sent for bacterial analysis, and results showed lower incidence of bacterial colonisation of the PneuX™ endotracheal tubes compared with the standard endotracheal tubes.http://www.journalofhospitalinfection.com/article/S0195-6701(16)30394-2/pdf

Significantly lower CPIS score when PneuX™ is used

This study examined the use of the PneuX™ in critically ill patients that were ventilated for more than 7 days. They used the CPIS score (a standardised and validated VAP scoring system which reflects lung injury due to infection and chemical damage) to assess VAP rates, comparing the PneuX™ to standard endotracheal tubes. The CPIS score was significantly lower with the PneuX™ endotracheal tubes compared with standard endotracheal tubes (P < 0.05).http://link.springer.com/article/10.1007/s00390-010-0211-4

No episodes of VAP with the PneuX™ in situ

This study assessed the PneuX™ in clinical practice, where patients were both initially intubated with the PneuX™ or underwent an elective tube exchange from a standard tube to a PneuX™ tube. They found that that there were no episodes of VAP whilst the PneuX™ was in situ. Tube exchange was found to be safe and straightforward to perform in this study.10 http://www.biomedcentral.com/1756-0500/4/92

PneuX™ prevents leakage of fluid past the cuff

A study done in Massachusetts General Hospital, USA, compared the performance of the PneuX ™ system to 4 standard endotracheal tubes. This study found that PneuX™ was the only endotracheal tube to prevent leakage of fluid past the cuff in all trials, and was superior to all other endotracheal tubes tested (P < 0.01).11 http://rc.rcjournal.com/content/early/2016/11/22/respcare.04996

PneuX™ prevents leakage of bacteria past the cuff and prevents leakage in all trachea sizes

This study performed at the University Hospital of Wales, looked at the performance of subglottic secretion drainage endotracheal tubes in preventing leakage of bacteria past the cuff. The Pneux™ prevented leakage of bacteria past the cuff and was superior in performance to all other 7 tested endotracheal tubes (P < 0.001). Four of the best performing endotracheal tubes were also tested in model tracheas of varying sizes and the PneuX™ was found to prevent leakage of fluid in every trachea size.12 https://pdfs.semanticscholar.org/ba90/a5a2d91aea42ad2422f69e24af2b0c6de741.pdf

PneuX™ prevents leakage past the cuff in mechanical ventilated models

This study compared the PneuX™ against standard endotracheal tubes in preventing leaking of fluid past the cuff in mechanical and cadaveric models. They found that the PneuX prevented leakage past cuff in all experiments, including tracheal suction and tube movement.13 http://bja.oxfordjournals.org/content/80/6/796

The cost of VAP is so high, that it’s possible to spend £500 on an endotracheal tube at commonly reported VAP rates even with modest risk reductions and it will still be cost saving for the NHS

This report assessed the cost effectiveness interventions used to preventing ventilator associated pneumonia in the ICU. They stated that the cost of a single episode of VAP in the ICU is around $40,000 in the US and around £10,000 in Europe, and this is the equivalent of a further 10 days of ventilation in the ICU. Their calculations state that, if an ICU has a VAP rate of 10%, that ICU can spend £500 on any intervention that prevents VAP by only 50%, and still be cost saving for the NHS.14 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3580630/

Using the PneuX saves >£700 per patient

This study compared the cost effectiveness of converting to the PneuX™ endotracheal tube from standard endotracheal tube. Their study results were independently analysed by statisticians at the Royal College of Surgeons and health economists the University of Birmingham, who found the using the PneuX™ endotracheal tube saved their hospital >£700 per patient. They found that using the PneuX™ reduced VAP by 50%, however in order for it to be cost neutral it only had to reduce VAP rates by 8%.4

Using the PneuX is highly cost saving

This report looks at the cost savings that can be achieved when using the PneuX™ endotracheal tube. Their report calculated that the cost of the PneuX™ was only 10% of that which would achieve cost neutrality for the NHS.15 http://journals.sagepub.com/doi/pdf/10.1177/175114371401500322

Patient’s opinions – East of England Citizens Senate, 2015

100% (13/13) of all patient’s surveyed said that they would want the PneuX system used in ICUs for their benefit and for their families. 

“In ICU I want the highest chance of recovering” 

This device is clearly cost effective in preventing pneumonia in intensive care and should be used in all NHS hospitals.”

“This device is critical to patient safety. We must collectively influence the commissioners to invest in this.” 

“I fail to see how any well – informed clinician or patient would opt to use a device other than this. Who would choose the acid–and-bugs-in-the-lung option?”

“Practical and safe especially in reducing health issues and stopping further complications.”

References

  1. Attributable mortality of ventilator-associated pneumonia: a meta-analysis of individual patient data from randomised prevention studies. Lancet Infect Dis. 2013;13:665-71. http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(13)70081-1/abstract
  2. Ventilator associated pneumonia: evolving definitions and preventive strategies. Respir Care. 2013;58:990-1007. http://rc.rcjournal.com/content/58/6/990.short
  3. New Endotracheal Tubes Designed to Prevent Ventilator-Associated Pneumonia: Do They Make a Difference? Respir Care. 2010;55:1046-1055. http://rc.rcjournal.com/content/55/8/1046.short
  4. VAP cost effectiveness study. Presented at the 29th European Association for Cardio-Thoracic Surgery. 2015, Amsterdam. 
  5. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002;165:867-903. http://www.atsjournals.org/doi/pdf/10.1164/ajrccm.165.7.2105078
  6. Tracheobronchial aspiration of gastric contents in critically ill tube-fed patients: Frequency, outcomes, and risk factors. Crit Care Med. 2006;34:1007-1015. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2396145/
  7. Significant reduction in ventilator-associated pneumonia with the Venner-PneuX System in high-risk patients undergoing cardiac surgery: the Low Ventilator-Associated-Pneumonia study. Eur J Cardiothorac Surg. 2015;47(3):e92-6 https://academic.oup.com/ejcts/article/47/3/e92/524144/Significant-reduction-in-ventilator-associated
  8. Incidence of endotracheal tube colonization with the use of PneuX endotracheal tubes in patients following cardiac surgery. J Hosp Infect. 2016;S0195-6701(16):30394-2. http://www.journalofhospitalinfection.com/article/S0195-6701(16)30394-2/pdf
  9. PneuX P.Y.TM System. Clinical application and the reduction of Clinical Pulmonary Infection Scores (CPIS) in long-term ventilated intensive care patients. 2011; 48(1):43-47 http://link.springer.com/article/10.1007/s00390-010-0211-4
  10. The incidence of ventilator-associated pneumonia using the PneuX System with or without elective endotracheal tube exchange: A pilot study. BMC Research Notes 2011;4:92 http://www.biomedcentral.com/1756-0500/4/92
  11. Performance of the PneuX System: A Bench Study Comparison With 4 Other Endotracheal Tube Cuffs. Respir Care. 2016; 62(1) (epub). http://rc.rcjournal.com/content/early/2016/11/22/respcare.04996
  12. An in vitro microbiological study comparing eight endotracheal tubes and their ability to prevent microaspiration. BMC Anaesthesiology 2017 (in press). https://pdfs.semanticscholar.org/ba90/a5a2d91aea42ad2422f69e24af2b0c6de741.pdf
  13. Evaluation of a new design of tracheal tube cuff to prevent leakage of fluid to the lungs. British Journal of Anaesthesia 1998;80(6):796-799 http://bja.oxfordjournals.org/content/80/6/796
  14. Number needed to treat and cost-effectiveness in the prevention of Ventilator Associated Pneumonia. Critical Care. 2012; 16(3):430 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3580630/
  15. Cost effectiveness in the prevention of VAP. Journal of the Intensive Care Society 2014:15:265–66 http://journals.sagepub.com/doi/pdf/10.1177/175114371401500322
  16. A low-volume, low-pressure tracheal tube cuff reduces pulmonary aspiration. Critical Care Medicine 2006;34(3):632-9 http://journals.lww.com/ccmjournal/Abstract/2006/03000/A_low_volume,_low_pressure_tracheal_tube_cuff.8.aspx
  17. The LoTrach system: its role in the prevention of ventilator-associated pneumonia. Nursing In Critical Care 2008;13(5):260-8 http://onlinelibrary.wiley.com/wol1/doi/10.1111/j.1478-5153.2008.00286.x/abstract
  18. The LoTrachTM: A Tracheal Tube for Critical Care. Journal of the Intensive Care Society 2007;8(1):72-75 http://journals.sagepub.com/doi/abs/10.1177/175114370700800128
  19. Prevention of tracheal aspiration using the pressure-limited tracheal tube cuff. Anaesthesia 1999;54(6): 559-563 http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2044.1999.00850.x/full
  20. The prevention of pulmonary aspiration with control of tracheal wall pressure using a silicone cuff. Anaesthesia and Intensive Care 2000; 28(6):660-5 http://www.aaic.net.au/document/?D=2000086
  21. Improving the shape and compliance characteristics of a high volume low pressure cuff improves tracheal seal. British Journal of Anaesthesia 1999;83(6):887-889 http://bja.oxfordjournals.org/content/83/6/887.short
  22. Inflation of a pressure-limited cuff inside a model trachea. Med Eng Phys. 2003;25(6):465-73 http://www.medengphys.com/article/S1350-4533(02)00252-7/abstract
  23. The pressure exerted on the tracheal wall by two endotracheal tube cuffs: A prospective observational bench-top, clinical and radiological study. BMC Anaesthesiology 2010;10:21 http://bmcanesthesiol.biomedcentral.com/articles/10.1186/1471-2253-10-21