Aerosols and droplets from COVID patients represent an important risk to surgical teams in the operating room (OR), who can be infected by patient breath or coughing (e.g. during endoscopy) or by leaks from within the patient abdomen (during laparoscopy, or keyhole surgery). These risks have the potential to ‘shut down’ much elective surgery during the current pandemic.
The PORSAV project developed two novel medical devices that address this challenge, carrying out clinical validation and ensuring readiness for large-scale production. The LeakTrap device is used in laparoscopic surgery; it consists of two vacuum rings that are placed (a) on the patient at the point of entry of the laparoscopic trocar, and (b) at the head of the trocar, where surgical instruments are inserted and removed; aerosols form surgical leaks are captured and pumped out of the OR. The EndoTrap device is a sleeve that captures gases from endoscopy equipment – patient breath, coughs, etc. are captured and filtered, protecting the endoscopy team.
Both devices were developed and prototyped by PORSAV partner Palliare (Galway, Ireland) prior to the start of the project. During the project, the prototypes were finalised, and then clinically validated in trials in Dublin (UCD, Ireland) and Strasbourg (IRCAD, France). Final design was completed, and mass production validated (Steripack, Poland).
A key innovation of the project is the use of novel Schlieren imaging technologies (UCD, Ireland) to capture photographs and video footage of the aerosols leaked into the operating room – and of their control by PORSAV devices. Schlieren imaging ‘photographs the invisible’ by capturing images based on differences in gas density, even when the gas is colourless. Videos created during the clinical validation generated a robust evidence base for raising awareness of the OR risks, driving adoption of the new technologies in surgical guidelines and demand in the market.
Societal Importance
The COVID pandemic created particular challenges for surgery. Surgery is a fundamental, life-saving, healthcare service. Laparoscopy is the optimum surgical approach in a wide range of conditions, with significant patient benefits over open surgery. Endoscopy is also a fundamental and common procedure. Both procedure types lead to elevated risk of viral transmission to healthcare staff. By addressing these risks, the devices developed by PORSAV help to protect OR staff, to keep surgery running, and to keep healthcare staff in post.
The overall objectives of the project were to:
a) characterise the nature and extent of aerosol leaks using Schlieren imaging;
b) complete development and certification of the two novel medical devices, LeakTrap and EndoTrap;
c) clinically validate the effectiveness of the devices in controlling laparoscopic and endoscopic leaks; and
d) enable the mass production and distribution of the devices to surgical teams and COVID care teams worldwide.
By the end of the project, each of these objectives was achieved. While vaccination has reduced the risk of COVID to surgical teams by the time of reporting, there are several related and serious risks in the operating room that remain problematic, and that EndoTrap and LeakTrap help to address. These include new variants and future viruses, exposure to surgical smoke, and exposure to other infections.
