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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Main Authors: Chien-Hung Liao, David A. Spain, Chih-Chi Chen, Chi-Tung Cheng, Wei-Cheng Lin, Dong-Ru Ho, Heng-Fu Lin, Fausto Catena
Format: Article
Language:English
Published: BMC 2025-01-01
Series:World Journal of Emergency Surgery
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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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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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