A Nitric Oxide (NOx) generating solution for prevention of VAP
Research type
Research Study
Full title
A Nitric Oxides (NOx) generating solution to prevent ventilator associated pneumonia in critically ill mechanically ventilated patients (NOVAP): Phase I non-randomised, dose-finding study A (single dose)
IRAS ID
105903
Contact name
Charles Hinds
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2011-005940-84
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
‘A liquid that restores the naturally occurring gas (Nitric Oxide) to prevent pneumonia in patients on breathing machines: A study to find the best dose’.
We have developed a new system that generates and delivers nitric oxide and other oxides of nitrogen (NO/NOx) to the stomach and oral cavity of mechanically ventilated patients. We hypothesise that the use of this solution to decontaminate the mouth, upper throat and stomach will significantly reduce the incidence of ventilator-associated pneumonia (VAP) in mechanically ventilated patients.
During critical illness, production of NO is markedly reduced in the digestive tract. This deficiency predisposes to bacterial overgrowth of the stomach and oral cavity and the subsequent development of VAP following unwanted inhalation of infected secretions. The NO generating solution is designed to restore normal levels of NOx in the oral cavity and stomach.
It is estimated that over 60,000 patients are mechanically ventilated in UK intensive care units (ICUs) every year, with an average stay of days and a cost of around £500M per annum (approximately 1-2 % of the total NHS budget). As the most prevalent infection in European ICUs, VAP accounts for more than half of all ICU acquired infections. The objective of this therapy is to reduce the incidence of VAP and the associated prolonged length of stay, morbidity, mortality and treatment costs.
Phase I and II studies with a prototype product will pave the way for future phase III trials, dependent on confirmation of efficacy, safety/tolerability and development of an easy-to-use bedside delivery system.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
13/SC/0486
Date of REC Opinion
23 Oct 2013
REC opinion
Further Information Favourable Opinion