1) How does the KatGuide work?
When using the KatGuide technique, blunt dissection in the safe triangle and control with a finger is used, just as in the conventional technique. The surgeon, however, has greater directional control. The following steps are taken:
Insert KatGuide in pleural cavity: The distal, curved part of the KatGuide is inserted in the pleural cavity, and the tip is directed towards the part of the pleural cavity that needs drainage.
Direct the KatGuide to the desired area of the pleural cavity. In most cases, the desired placement of a chest tube is at the top for pneumothorax. The desired placement is at the bottom in case of fluid in the pleural cavity.
Verify the insertion direction: When using the KatGuide, the surgeon can see the insertion direction for the chest tube by looking at the handle. The handle is held parallel to the skin, to ensure that the insertion direction is parallel to the lung surface. This prevents placing the chest tube in the interlobar fissure or lung tissue, which are some of the most common locations for malplacement1.
Remove KatGuide: When the chest tube is in place, the KatGuide is removed by holding the chest tube at the desired fixed depth while carefully pulling out the KatGuide by following the curved shape of the distal part.
See also animation and userguide illustrating the pleural drainage procedure with the KatGuide.
1Remérand F et al, Incidence of chest tube malposition in the critically ill: a prospective computed tomography study. Anesthesiology. 2007 Jun;106(6):1112-9.
2) What are the benefits of using the KatGuide compared to the conventional procedure using a Kelly clamp?
1) Minimizes the risk of lung perforation and malplacement in the interlobular tissue
2) Allows full control of the direction of the chest tube
3) Facilitates optimal drainage through optimal placement of the chest tube.
4) Shortens chest tube time and hospital stay
3) Does the KatGuide conform to the accepted medical standards and regulations?
Yes, the tools were developed according to the relevant guidelines:
- Medical Device Directive, Council Directive 93/42/EEC of 14 June 1993. 1993L0042-EN-11.10.2007
- The investigational devices are designed and manufactured in compliance with ISO EN 13485:2009
- Application of risk management to medical devices - DS/EN ISO 14971:2007 (E)
- Packaging for terminally sterilized medical devices – ISO 11607
- Sterilization of medical devices – requirements for medical devices to be designated “Sterile” DS/EN 556-1
- Sterilization of Health Care Products Package (ETO) – ISO 11135:2007
- Information supplied by the manufacturer of medical devices: EN 1041:2008
- Symbols to be used with medical device labels, labeling and information to be supplied – ISO15223:2007
- Symbols for use in the labeling of medical devices – EN 980:2008
- Clean rooms and Associated Controlled Environments Package – ISO 14644:2007
- Clinical investigating of medical devices for human subjects, good clinical practice - DS/EN ISO14155:2011 (E)
- Registration of personal data according to requirements from Datatilsynet (the Danish data protection agency)
See the Conformance page for details about compliance to BTS guidelines
4) Are you running any clinical studies to validate this tool?
Yes, we are currently running a clinical study to validate the long-standing assumption that pleural drains should be placed at the upper part of the cavity when draining air and in the lower part when draining fluid. The trial is a prospective randomized GCP-monitored parallel group controlled study that is currently in progress at three University Hospitals in Denmark.
The KatGuide technique employs the conventional blunt dissection technique as recommended by BTS. In the clinical trial, the primary endpoint is chest tube placement, and secondary endpoints are duration of chest tube, duration of hospital stay and number of repeated surgeries.
5) How can the KatGuide contribute to financial benefits?
The ability to place drains more accurately will probably reduce the need for repeat surgeries, thus shortening hospital stays and contributing to substantial financial benefits. Solving the clinical problem faster may have the following associated benefits:
- Substantial financial benefits due to shorter hospital stays
- Reduction of the risk of wound infection and infection in the pleural cavity (empyema).
- Prevention of serious adverse events
- Healthier, more satisfied patients
6) How can my company get involved and benefit from this innovation?
If you’re company manufactures medical instruments, we would be happy to meet with you regarding a possible collaboration. Please contact us.
7) Where can I get more information?
Have a look at our Resources page for more information on lung clinical trials and research, and you are also welcome to contact us.
8) Are the developers available for an interview?
Yes, please contact Niels Katballe and/or Peter Heydorn.