SIAP (Spine Intra-Abdominal Pressure) studie
The METC (Medical Ethic Test Commission) has approved the SIAP studie from dr. van Eijs (anesthesiologist at ETZ, Tilburg). The study enrolled 40 patients aged 18-70 years with a body weight encoded_tag_open 120 kg < 120 kg enrolled.
The SIAP study investigates the effect of the use of the Inflatable Prone Supports (IPS) from Ergotrics on the Intra-Abdominal Pressure (IAP) during spinal surgery.
The aim of this study is to demonstrate that the Inflatable Prone Supports (IPS) are able to lower the IAP of patients in the prone position. When the patient’s position is changed to the prone position, the IAP is increased as a result of abdominal compression. Increased IAP has previously been shown to be associated with increased bleeding. The ability to reduce IAP is assessed by measuring IAP before and after inflation of the IPS.
To map the user feedback from the IBO, IPS and Hummingbird, Ergotrics, with the financial support of Flanders Innovation & Entrepreneurship, organized the OPPE study (Optimization of the Proning Procedure in Europe). 7 renowned hospitals in 5 countries have already participated in the study (Universitätsspital Zürich; Krankenhaus Wermelskrichen, Germany; Schön Klinink Vogtareuth, Germany; University Hospital Brussels, Belgium; Akademiska sjukhuset Uppsala, Sweden; Elisabeth-Tweesteden Hospital, Netherlands; MC Zuyderland Heerlen, The Netherlands) and 3 other hospitals have committed to participate in the study in 2020.
Pressure Point Studie
Pressure points on the skin increase the risk of pressure ulcers. All patients undergoing (long-term) surgery are at risk of developing pressure ulcers. Research has shown that it is important to keep pressure below 30mmHg to prevent pressure ulcers. Therefore, it is likely that redistribution of the pressure will reduce the associated risk. It is generally accepted that air results in better pressure redistribution, this study will demonstrate that positioning on the IPS results in a pressure of less than 30mmHg over the entire surface of the chest and pelvic skin.
This study shows the pressure redistribution and identifies the areas of highest pressure using pressure mapping. Different positioning materials (Ergotrics’ Inflatable Prone Support (IPS), Steffee cushion, Wilson-Frame, traditional gel / foam filled cushions / bolsters / rolls) will be compared in terms of pressure distribution and areas of highest pressure. In addition, the aim of this study is to demonstrate that air positioning (IPS) results in a pressure of less than 30mmHg over the entire surface of the chest and pelvis.
Below you will find more scientific background information about the importance of better pressure distribution and the benefits for the patient.
- Bedsores from surgery are a common and important problem.
- 45 – 53% of hospital pressure ulcers are developed in the operating room (Riemenschneider 2018, Kirkland-Walsh 2015).
- The treatment of bedsores is 8.5% or higher in all patients undergoing surgery lasting more than 3 hours. (Riemenschneider 2018, Hai-Yan Huang 2013) and 8.8% in abdominal position (Gao 2018).
- After the first 4 hours of surgery, the risk of pressure ulcers increased by 33% for every 30 minutes of surgery (Kirkland-Walsh 2015).
- It has been found that bedsores are more common in patients with long-term high surface pressure over time (Kirkland-Walsh 2015).
- The development of pressure ulcers in patients subjected to medium and large surgeries was 20.6%, with the main location being the fuselage (35.1%) (Scarlatti 2011).
- The occurrence of postoperative skin damage is relatively high in patients undergoing spine surgery in abdominal position. Therefore, it is recommended to take appropriate precautions to prevent these complications (Bagheri 2019).
- Patients who received prone supports had a significantly lower arrival of surgery-related bedsores compared to patients using a standard mattress (Hai-Yan Huang 2013).
- Health care costs related to pressure ulcers are increasing annually and are estimated to be between $44K and 128K per pass-through wound in the US (Kirkland-Walsh 2015).
- Although researchers don’t specifically know how much pressure over how much time causes skin damage, 30-32 mm Hg has long been the “gold standard” of pressure measurement (Hanson 2009, Kirkland-Walsh 2015).