Feasibility and accuracy of continuous intraabdominal pressure monitoring with a capsular device in human pilot trial
Abstract Background Intrabdominal pressure (IAP) is an important parameter. Elevated IAP can reduce visceral perfusion, lead to intraabdominal hypertension, and result in life-threatening abdominal compartment syndrome. While ingestible capsular devices have been used for various abdominal diagnoses...
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BMC
2025-01-01
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Online Access: | https://doi.org/10.1186/s13017-024-00569-0 |
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author | Chien-Hung Liao David A. Spain Chih-Chi Chen Chi-Tung Cheng Wei-Cheng Lin Dong-Ru Ho Heng-Fu Lin Fausto Catena |
author_facet | Chien-Hung Liao David A. Spain Chih-Chi Chen Chi-Tung Cheng Wei-Cheng Lin Dong-Ru Ho Heng-Fu Lin Fausto Catena |
author_sort | Chien-Hung Liao |
collection | DOAJ |
description | Abstract Background Intrabdominal pressure (IAP) is an important parameter. Elevated IAP can reduce visceral perfusion, lead to intraabdominal hypertension, and result in life-threatening abdominal compartment syndrome. While ingestible capsular devices have been used for various abdominal diagnoses, their application in continuous IAP monitoring remains unproven. Method We conducted a prospective clinical trial to evaluate the feasibility of IAP measurement using a digital capsule PressureDOT, an ingestible capsule equipped with wireless transmission capability and a pressure sensor, then compared its reliability with conventional intravesical method. Patients undergoing laparoscopic or robotic surgeries were recruited. During surgery, we created pneumoperitoneum by inflating CO2 into the peritoneal cavity and IAP was simultaneously monitored using both the ingestible capsules and intravesical measurements from Foley catheter. We assessed the feasibility of signal transmission and the accuracy of pressure measurements. Results Six patients were enrolled in this pilot study. No adverse events were reported, and the average first-intake time was within 24 h. All capsules were successfully expelled, with an average excretion time of 81 h. In the summarized data, the mean IAPdot is 0.6 mmHg lower than the IAPivp, with a standard deviation of 1.68 mmHg. However, capsule measurements showed excellent correlation with intravesical IAP measurements, with an intraclass correlation coefficient of 0.916 (95% CI: 0.8821–0.9320). Conclusion Our study demonstrates the feasibility and safety of using digital capsules for continuous IAP monitoring, providing the agreement between IAP measurements from digital capsules and conventional intravesical measurement within a near-normal pressure. |
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institution | Kabale University |
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language | English |
publishDate | 2025-01-01 |
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series | World Journal of Emergency Surgery |
spelling | doaj-art-94f04e768afd4ed5895fe0bde625c0fb2025-02-02T12:13:42ZengBMCWorld Journal of Emergency Surgery1749-79222025-01-0120111010.1186/s13017-024-00569-0Feasibility and accuracy of continuous intraabdominal pressure monitoring with a capsular device in human pilot trialChien-Hung Liao0David A. Spain1Chih-Chi Chen2Chi-Tung Cheng3Wei-Cheng Lin4Dong-Ru Ho5Heng-Fu Lin6Fausto Catena7Department of Trauma and Emergency Surgery, Chang Gung Memorial Hospital, Chang Gung UniversityDepartment of Surgery, Stanford UniversityDepartment of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital, Chang Gung UniversityDepartment of Trauma and Emergency Surgery, Chang Gung Memorial Hospital, Chang Gung UniversityDepartment of Electrical Engineering, Chang Gung UniversityDepartment of Surgery, Division of Urology, Chang Gung Memorial Hospital, Chang Gung UniversityDivision of Trauma, Department of Surgery, Far Eastern Memorial HospitalUniversity of Bologna- Bufalini HospitalAbstract Background Intrabdominal pressure (IAP) is an important parameter. Elevated IAP can reduce visceral perfusion, lead to intraabdominal hypertension, and result in life-threatening abdominal compartment syndrome. While ingestible capsular devices have been used for various abdominal diagnoses, their application in continuous IAP monitoring remains unproven. Method We conducted a prospective clinical trial to evaluate the feasibility of IAP measurement using a digital capsule PressureDOT, an ingestible capsule equipped with wireless transmission capability and a pressure sensor, then compared its reliability with conventional intravesical method. Patients undergoing laparoscopic or robotic surgeries were recruited. During surgery, we created pneumoperitoneum by inflating CO2 into the peritoneal cavity and IAP was simultaneously monitored using both the ingestible capsules and intravesical measurements from Foley catheter. We assessed the feasibility of signal transmission and the accuracy of pressure measurements. Results Six patients were enrolled in this pilot study. No adverse events were reported, and the average first-intake time was within 24 h. All capsules were successfully expelled, with an average excretion time of 81 h. In the summarized data, the mean IAPdot is 0.6 mmHg lower than the IAPivp, with a standard deviation of 1.68 mmHg. However, capsule measurements showed excellent correlation with intravesical IAP measurements, with an intraclass correlation coefficient of 0.916 (95% CI: 0.8821–0.9320). Conclusion Our study demonstrates the feasibility and safety of using digital capsules for continuous IAP monitoring, providing the agreement between IAP measurements from digital capsules and conventional intravesical measurement within a near-normal pressure.https://doi.org/10.1186/s13017-024-00569-0Intraabdominal pressureAbdominal compartment syndromeCapsular sensorDigital health |
spellingShingle | Chien-Hung Liao David A. Spain Chih-Chi Chen Chi-Tung Cheng Wei-Cheng Lin Dong-Ru Ho Heng-Fu Lin Fausto Catena Feasibility and accuracy of continuous intraabdominal pressure monitoring with a capsular device in human pilot trial World Journal of Emergency Surgery Intraabdominal pressure Abdominal compartment syndrome Capsular sensor Digital health |
title | Feasibility and accuracy of continuous intraabdominal pressure monitoring with a capsular device in human pilot trial |
title_full | Feasibility and accuracy of continuous intraabdominal pressure monitoring with a capsular device in human pilot trial |
title_fullStr | Feasibility and accuracy of continuous intraabdominal pressure monitoring with a capsular device in human pilot trial |
title_full_unstemmed | Feasibility and accuracy of continuous intraabdominal pressure monitoring with a capsular device in human pilot trial |
title_short | Feasibility and accuracy of continuous intraabdominal pressure monitoring with a capsular device in human pilot trial |
title_sort | feasibility and accuracy of continuous intraabdominal pressure monitoring with a capsular device in human pilot trial |
topic | Intraabdominal pressure Abdominal compartment syndrome Capsular sensor Digital health |
url | https://doi.org/10.1186/s13017-024-00569-0 |
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