Telemedicine for the remote mentoring of damage control surgery in critically injured trauma patients

Plain English summary of protocol

Background and study aims
Bleeding to death is the most preventable cause of post-traumatic death on earth. Many of these victims could be saved with relatively basic surgery if only they were in a location where surgery could be performed. Damage Control Surgery (DCS), is an approach which aims to simplify basic operations to save lives even if further surgery is required. Medical technology is fast advancing. Telemedicine is used to provide medical direction over a distance, and includes remote telementoring (RTM) where experts provide real-time remote guidance might allow non-surgeons to do DCS. Therefore this study will study numerous factors required to best support non-surgeons in the performance of life-saving techniques of resuscitation including performing DCS in the abdominal cavity. These factors will consist of the performance differences between trained surgeons and non-surgeons, the ability to remotely mentor non-surgeons, and their relative stress while doing so, and the ability to do so in stressful and difficult situations including a remote medical outpost, on board a ship, and during weightless aboard a “zero-G” aircraft. The main tools to be used will be the plastic organs and blood vessels of the Human Worn Partial Task Surgical Simulator (CutSuit) which is a hyper-realistic training tool that allows the performance of realistic surgical procedures on a simulated victim with realistic bleeding and the feel of real skin and tissue. We want to test if (a) experienced surgeons will lose less blood and experience less stress than non-surgeons and (b) whether RTM non-surgeons can be guided to perform life-saving procedures and that RTM will reduce stress even in far-forward operating bases, on-board ships, and weightlessness.

Who can participate?
Surgeons and military medical technicians.

What does the study involve?
In general, this study assesses “naïve first responders” (i.e. medical technicians) ability to pack the abdomen of a seriously injured person at risk of bleeding to death with the guidance of a surgeon though RTM. Participants are randomly allocated into one of two groups. Those in group 1 receive RTM with an experienced surgeon. Those in group 2 do not receive RTM. Each participant fills in a questionnaire about their medical training background and any surgical training background in particular. They are also asked questions regarding any familiarity that they have with surgical simulation and, in particular, any experience of the CutSuit. They are all given a brief refresher course on hemorrhage control and how to potentially handle medical cases where the victim is bleeding to death from either a massive limb or abdomen injury. Each participant is then asked to perform hemorrhage control using either a first aid method or to perform a cut in the middle of the abdomen to gain entrance to the abdominal cavity, determine the site of the bleeding and pack within the abdominal cavity to compress this bleeding. Each participants performance is assessed according to the time taken to complete the procedure (TTTC) and the volume of shed blood (VSB). Comparisons are made within the two groups assessing different techniques for closing wounds and performing life changing procedures in different environments. We also compare the TTTC and VSB between naïve first responders and experienced surgeons and between surgeons performing in a normal gravity environment verses a weightless environment.

What are the possible benefits and risks of participating?
As with any surgical intervention, there is always a risk to the participant in self-inflicted injuries from handling scalpels, hemostatic clips, or other sharp instruments. These are similar risks to those that medical personal face when learning any invasive procedures. In order to partially mitigate these risks there will be very experienced “safety surgeons” present who will be observing for any unduly unsafe procedures that are that may place the participant at risk. The “safety surgeons” have the authority to halt the simulation and to exclude the participant from further participation at no penalty to the participant. While sharp injuries are possible there will be no risks of biocontamination as the CutSuit and fluids are completely inanimate. If the “safety surgeons” also perceive that any participant is undergoing undo physical or psychological distress they will halt the simulation and debrief the participant at no penalty to the participant. The purpose of this study is to collect data in order to further the mission of advancing resuscitative surgery in the field and “far forward situations”. This is not intended as a training exercise for the participants.

Where is the study run from?
Flight Research Laboratory, National Research Council of Canada and the Canadian Field Hospital (Ottawa Detachment)

When is the study starting and how long is it expected to run for?
October 2014 to September 2025

Who is funding the study?
1. Canadian Forces Medical Services
2. Royal College of Physicians and Surgeons of Canada

Who is the main contact?
Professor Andrew Kirkpatrick
andrew.kirkpatrick@albertahealthservices.ca

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Canada

Study participating centres

Sponsor information

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

NHW 20/12/2024: Internal review.
24/02/2022: The overall trial end date has been changed from 21/06/2017 to 01/09/2025 and the plain English summary has been updated accordingly.
07/01/2022: Internal review.
04/01/2022: Publication reference added.
25/11/2020: Publication reference added.
19/09/2018: Publication reference added.
11/04/2016: Publication reference added.