Periodic Reporting for period 2 - PORSAV (Controlling viral aerosols in COVID-19 and beyond)
Periodo di rendicontazione: 2021-11-01 al 2022-07-31
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.
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.
The main results achieved by PORSAV were as follows.
-The design of the two medical devices (LeakTrap and EndoTrap) was finalised and the documentation for large-scale production was completed. Devices for the project’s clinical validation were produced. FDA approval was secured for the EndoTrap and LeakTrap devices. CE Marking of EndoTrap is complete, and certification of LeakTrap is currently in progress.
-Medical Device production facilities were established at Steripack and manufacturing as successfully carried out.
-Ethical approval submissions for the clinical validation of LeakTrap and EndoTrap were made in Ireland and France. Approval for both devices was secured, enabling the clinical validation of both devices to be completed.
-LeakTrap involves the use of a novel portable Schlieren system to identify leaks of surgical smoke. This was reworked and refined, and installed at both clinical validation sites. This system proved capable of robustly delivering the data required for the clinical validation of the PORSAV devices, which was successfully completed.
-Training and engagement materials designed to train surgeons in the use of LeatTrap and EndoTrap have been developed. Meetings with professional bodies (SAGES, EAES) took place.
-The project and its results were disseminated through the project website and social media. Promotional and training videos are a particular highlight. The project and its outcomes were publicised at nine major conferences and a commercial advertising campaign took place. Distribution and sales agreements with third parties are under negotiation.
-Project management was effective throughout, dealing with issues caused by the pandemic and maintaining focus and progress.
-All ethics deliverables were submitted as planned and the project operated in full compliance with its ethical commitments.
-The design of the two medical devices (LeakTrap and EndoTrap) was finalised and the documentation for large-scale production was completed. Devices for the project’s clinical validation were produced. FDA approval was secured for the EndoTrap and LeakTrap devices. CE Marking of EndoTrap is complete, and certification of LeakTrap is currently in progress.
-Medical Device production facilities were established at Steripack and manufacturing as successfully carried out.
-Ethical approval submissions for the clinical validation of LeakTrap and EndoTrap were made in Ireland and France. Approval for both devices was secured, enabling the clinical validation of both devices to be completed.
-LeakTrap involves the use of a novel portable Schlieren system to identify leaks of surgical smoke. This was reworked and refined, and installed at both clinical validation sites. This system proved capable of robustly delivering the data required for the clinical validation of the PORSAV devices, which was successfully completed.
-Training and engagement materials designed to train surgeons in the use of LeatTrap and EndoTrap have been developed. Meetings with professional bodies (SAGES, EAES) took place.
-The project and its results were disseminated through the project website and social media. Promotional and training videos are a particular highlight. The project and its outcomes were publicised at nine major conferences and a commercial advertising campaign took place. Distribution and sales agreements with third parties are under negotiation.
-Project management was effective throughout, dealing with issues caused by the pandemic and maintaining focus and progress.
-All ethics deliverables were submitted as planned and the project operated in full compliance with its ethical commitments.
The context of the PORSAV project was leaks and aerosols in the operating room, and how to control them. There is to date limited awareness among surgical staff of the prevalence and scale of leaks around trocars and during endoscopy. The COVID-19 crisis sharply raised interest in this topic, but there is a global lack of high quality information about the frequency and extent of leaks: where they occur, how they spread in the air, how broadly dispersed they become in the OR atmosphere and on surfaces, and how vulnerable staff are to inhaling or otherwise being exposed to them.
PORSAV developed novel methodologies capture the size, distribution and duration of leaks during surgery and endoscopy, for a large number of patients in two hospitals. This generated the first substantial evidence base for surgical leaks. While we focus on COVID in this project, the data will be relevant to other viral aerosols and droplets, to surgical smoke and other operating-room contaminants. The underlying Schlieren technology is very innovative and beyond the state of the art. Prior to our work, Schlieren imaging required very precise calibration and ideal (laboratory) conditions. Work at UCD has led to portable, easily-setup systems, composed of mass-market cameras and reflectors, suitable for working ORs.
PORSAV medical devices capture surgical leaks at source. These devices integrate with the trocar or the endoscope, removing leaked contaminants before they enter the operating room.
IMPACT: Surgery is a critical part of the healthcare system and an essential therapy for immense numbers of patients; a large proportion of surgeries are laparascopic, because this approach has immense patient benefit. New and under-appreciated risks to surgical teams can disrupt the availability of this essential service: at the start of the COVID pandemic, some surgical professional societies were advocating the cessation of laparoscopy entirely. PORSAV is helping to keep surgery available. Even after the pandemic has passed, the risks associated with viral leaks, smoke and micro-particles remain substantial; the PORSAV technologies will help to keep surgical staff safe.
PORSAV developed novel methodologies capture the size, distribution and duration of leaks during surgery and endoscopy, for a large number of patients in two hospitals. This generated the first substantial evidence base for surgical leaks. While we focus on COVID in this project, the data will be relevant to other viral aerosols and droplets, to surgical smoke and other operating-room contaminants. The underlying Schlieren technology is very innovative and beyond the state of the art. Prior to our work, Schlieren imaging required very precise calibration and ideal (laboratory) conditions. Work at UCD has led to portable, easily-setup systems, composed of mass-market cameras and reflectors, suitable for working ORs.
PORSAV medical devices capture surgical leaks at source. These devices integrate with the trocar or the endoscope, removing leaked contaminants before they enter the operating room.
IMPACT: Surgery is a critical part of the healthcare system and an essential therapy for immense numbers of patients; a large proportion of surgeries are laparascopic, because this approach has immense patient benefit. New and under-appreciated risks to surgical teams can disrupt the availability of this essential service: at the start of the COVID pandemic, some surgical professional societies were advocating the cessation of laparoscopy entirely. PORSAV is helping to keep surgery available. Even after the pandemic has passed, the risks associated with viral leaks, smoke and micro-particles remain substantial; the PORSAV technologies will help to keep surgical staff safe.