FIbreOxyll v1.0
Research type
Research Study
Full title
First-in-man evaluation of a fibre optic sensor to monitor ventilatory oscillations in the arterial partial pressure of oxygen in real-time: a feasibility study in patients with the acute respiratory distress syndrome.
IRAS ID
321576
Contact name
Andrew Farmery
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
ISRCTN Number
ISRCTN10257246
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
The acute respiratory distress syndrome (ARDS) is a life-threatening condition of severe respiratory failure often requiring mechanical ventilation to ensure adequate gas-exchange. Setting mechanical ventilation is a subject of debate, due to the lack of parameters informing on its appropriateness at the bedside. In animal models, breath-by-breath oscillations in the arterial partial pressure of oxygen (PaO2) have been shown to provide promising insights in this regard. However, devices measuring PaO2 oscillations were either slow-responding, or non-biocompatible, preventing human application. The purpose of the present work is to investigate the feasibility of continuous PaO2 monitoring in ARDS patients, using a new fast-responding, biocompatible and patient-safe fibre optic sensor. The latter is a thin catheter introduced in indwelling arterial lines and connected to a monitor which displays PaO2 in real-time. Mechanically ventilated ARDS patients with an indwelling arterial line will be enrolled. The sensor will be inserted in the arterial line at enrolment and maintained in site for as long as patients remain mechanically ventilated. PaO2 will be monitored and recorded during routine clinical care, and no intervention is foreseen. Feasibility of measurement will be defined as the capability of the sensor to detect changes in PaO2 oscillations induced by manoeuvres of routine clinical care which we have previously studied in animal models. Forty patients are required for this task. Off-line analysis will be subsequently performed to investigate possible relationships between PaO2 oscillations and other respiratory and hemodynamic parameters currently monitored to assess the appropriateness of mechanical ventilation. If feasibility of real-time PaO2 monitoring can be demonstrated, this technology has the potential to open a fascinating new field of ARDS research and transform patient care.
REC name
Wales REC 7
REC reference
23/WA/0212
Date of REC Opinion
25 Aug 2023
REC opinion
Further Information Favourable Opinion