PHASES v1.0
Research type
Research Study
Full title
PHArmacokinetics, Safety and Efficacy of a novel method of Sevoflurane delivery (PHASES)
IRAS ID
320908
Contact name
Andrew Miller
Contact email
Sponsor organisation
Intersurgical Ltd
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Use of sedation, rather than general anaesthesia, has many benefits, including lower rates of postoperative confusion, shorter hospital stay and reduced environmental impact. Effective sedation is a balancing act between awareness and anaesthesia. If too little sedation is given patients may recall intraoperative events and if too much is given patients may require help with their breathing or blood pressure. Although in theory the best way to achieve this balance is to allow patients to sedate themselves by pressing a button, at present sedation is almost exclusively clinician-delivered. This is largely because devices to administer patient-controlled sedation have not been developed. Therefore, this first-in-human clinical investigation of a medical device aims to establish the safety and efficacy of the IDAS mask: a novel device which delivers patient-controlled sevoflurane sedation.
The study will be conducted in an operating theatre suite at Imperial College Healthcare NHS trust and will be funded by Intersurgical Ltd. Up to 18 healthy participants will visit the study centre on one occasion to undertake the study protocol. The study protocol consists of 3 experiments which will investigate the capacity of the IDAS mask to deliver safe and effective patient-controlled sevoflurane sedation. The visit duration will be approximately 12 hours.
If successful, this study will be a steppingstone towards larger seminal clinical investigations of the IDAS mask in patient populations and ultimately could facilitate improvements in the way that sedation is delivered.
REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0102
Date of REC Opinion
29 Sep 2024
REC opinion
Favourable Opinion