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Alex Tiong Heng Sia - One of the best experts on this subject based on the ideXlab platform.

  • A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain
    BMC Anesthesiology, 2020
    Co-Authors: Ban Leong Sng, Chin Wen Tan, Nian-lin Reena Han, Rehena Sultana, Daryl Jian’an Tan, Alex Tiong Heng Sia
    Abstract:

    Background We developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) Analgesic Infusion Pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients’ vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia. Methods Nineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 h until assessment of patient satisfaction on the VPIA Analgesic Infusion Pump. Results The primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (

  • A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain.
    BMC anesthesiology, 2020
    Co-Authors: Ban Leong Sng, Daryl Jian An Tan, Chin Wen Tan, Nian-lin Reena Han, Rehena Sultana, Alex Tiong Heng Sia
    Abstract:

    We developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) Analgesic Infusion Pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients’ vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia. Nineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 h until assessment of patient satisfaction on the VPIA Analgesic Infusion Pump. The primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (

  • A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain
    2020
    Co-Authors: Ban Leong Sng, Daryl Jian An Tan, Chin Wen Tan, Nian-lin Reena Han, Rehena Sultana, Alex Tiong Heng Sia
    Abstract:

    Abstract Background: We developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) Analgesic Infusion Pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients’ vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia.Methods: Nineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 hours until assessment of patient satisfaction on the VPIA Analgesic Infusion Pump.Results: The primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (<95%) during the study period. Only 6 (31.6%) patients had oxygen desaturation that persisted for more than 5 minutes. The median percentage time spent during treatment that oxygen saturation fell below 95% was 1.9%. Fourteen (73.7%) out of 19 patients encountered safety pause, due to transient oxygen desaturation or bradycardia. The patients’ median [IQR] pain scores at rest and at movement after post-op 24 hours were 0.0 [2.0] and 3.0 [2.0], respectively. The average morphine consumption in the first 24 hours was 12.5 ± 7.1mg. All patients were satisfied with their experience with the VPIA Analgesic Infusion Pump. Conclusions: The use of VPIA Analgesic Infusion Pump, when integrated with continuous vital sign monitor and variable lockout algorithm, was able to provide pain relief with good patient satisfaction.Keywords: Infusion Pump, postoperative pain, vital sign monitoring, oxygen desaturation.Trial registration: This study was registered on clinicaltrials.gov registry (NCT02804022) on 28 Feb 2016.

  • A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain
    2020
    Co-Authors: Ban Leong Sng, Daryl Jian An Tan, Chin Wen Tan, Nian-lin Reena Han, Rehena Sultana, Alex Tiong Heng Sia
    Abstract:

    Abstract Background: We developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) Analgesic Infusion Pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients’ vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia.Methods: Nineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 hours until assessment of patient satisfaction on the VPIA Analgesic Infusion Pump.Results: The primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (<95%) during the study period. Only 6 (31.6%) patients had oxygen desaturation that persisted for more than 5 minutes. The median percentage time during treatment that oxygen saturation fell below 95% was 1.9%. Fourteen (73.7%) out of 19 patients encountered safety pause, due to transient oxygen desaturation or bradycardia. The patients’ median [IQR] pain scores at rest and at movement after post-op 24 hours were 0.0 [2.0] and 3.0 [2.0], respectively. The average morphine consumption in the first 24 hours was 12.5 ± 7.1mg. All patients were satisfied with their experience with the VPIA Analgesic Infusion Pump. Conclusions: The use of VPIA Analgesic Infusion Pump, when integrated with continuous vital sign monitor and variable lockout algorithm, was able to provide pain relief with good patient satisfaction.Trial registration: This study was registered on clinicaltrials.gov registry (NCT02804022) on 28 Feb 2016.

  • A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain: a case series
    2020
    Co-Authors: Ban Leong Sng, Daryl Jian An Tan, Chin Wen Tan, Nian-lin Reena Han, Rehena Sultana, Alex Tiong Heng Sia
    Abstract:

    Abstract Background We developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) Analgesic Infusion Pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients’ vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia. Methods Nineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 hours until assessment of patient satisfaction on the VPIA Analgesic Infusion Pump. Results The primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (<95%) during the study period. Only 6 (31.6%) patients had oxygen desaturation that persisted for more than 5 minutes. The median percentage time during treatment that oxygen saturation fell below 95% was 1.9%. Fourteen (73.7%) out of 19 patients encountered safety pause, due to transient oxygen desaturation or bradycardia. The patients’ median [IQR] pain scores at rest and at movement after post-op 24 hours were 0.0 [2.0] and 3.0 [2.0], respectively. The average morphine consumption in the first 24 hours was 12.5 ± 7.1mg. All patients were satisfied with their experience with the VPIA Analgesic Infusion Pump. Conclusions The use of VPIA Analgesic Infusion Pump, when integrated with continuous vital sign monitor and variable lockout algorithm, was able to provide pain relief with good patient satisfaction.

Mats P E Heimdahl - One of the best experts on this subject based on the ideXlab platform.

  • requirements reference models revisited accommodating hierarchy in system design
    IEEE International Conference on Requirements Engineering, 2019
    Co-Authors: Anitha Murugesan, Sanjai Rayadurgam, Mats P E Heimdahl
    Abstract:

    Reference models such as Parnas' four-variable model, Jackson's and Zaves' world machine model, and Gunther et al.'s WRSPM model abstractly define and relate key artifacts in requirements engineering. Such reference models are intended to serve as a frame of reference for engineers to understand and reason about the artifacts involved in requirements engineering. However, when discussing the requirements of modern systems that are developed in a hierarchical and middle-out manner, these reference models do not provide a framework in which the relationship between requirements and architecture is explicitly discussed. Conceptual clarity about this relationship is crucial since the architecture and requirements for such systems become intrinsically intertwined as the architectural choices made during development influence the requirements and vice-versa. Hence, to precisely determine the scope of specifying requirements, distinguish requirements from architecture details, reason about the requirements, and determine how the requirements are realized in the system, we argue that a requirements reference model intended as a reference for such systems must explicitly discuss the architecture - requirements relationship. To that end, we define a hierarchical reference model that formally, yet abstractly, captures the intertwined relationship between the architecture and requirements in a way that will serve the same purpose as other models, but be more suitable for modern systems where architecture and requirements co-evolve. To illustrate the concepts in this model, we use a generic patient-controlled Analgesic Infusion Pump system as a case example.

Oleg Sokolsky - One of the best experts on this subject based on the ideXlab platform.

  • papers/358 Formal Methods Based Development of a PCA Infusion Pump Reference Model: Generic Infusion Pump (GIP) Project
    2010
    Co-Authors: Oleg Sokolsky, Raoul Jetley, David Arney, Paul Jones, Insup Lee
    Abstract:

    As software becomes ever more ubiquitous and complex in medical devices, it becomes increasingly important to assure that it performs safely and effectively. The critical nature of medical devices necessitates that the software used therein be reliable and free of errors. It becomes imperative, therefore, to have a conformance review process in place to ascertain the correctness of the software and to ensure that it meets all requirements and standards. Formal methods have long been suggested as a means to design and develop medical device software. However, most manufacturers shy from using these techniques, citing them as too complex and time consuming. As a result, (potentially life-threatening) errors are often not discovered until a device is already on the market. In this paper we present a reference model based approach to software conformance checking. Reference models enable the application of formal methods to software conformance checking, and provide a framework for rigorous testing. To illustrate the approach, we develop the reference model for a Generic Patient Controlled Analgesic Infusion Pump, and explain how it can be used to aid software conformance checking in a regulatory environment.

  • formal methods based development of a pca Infusion Pump reference model generic Infusion Pump gip project
    2007 Joint Workshop on High Confidence Medical Devices Software and Systems and Medical Device Plug-and-Play Interoperability (HCMDSS-MDPnP 2007), 2007
    Co-Authors: David Arney, Raoul Jetley, Paul Jones, Oleg Sokolsky
    Abstract:

    As software becomes ever more ubiquitous and complex in medical devices, it becomes increasingly important to assure that it performs safely and effectively. The critical nature of medical devices necessitates that the software used therein be reliable and free of errors. It becomes imperative, therefore, to have a conformance review process in place to ascertain the correctness of the software and to ensure that it meets all requirements and standards. Formal methods have long been suggested as a means to design and develop medical device software. However, most manufacturers shy from using these techniques, citing them as too complex and time consuming. As a result, (potentially life-threatening) errors are often not discovered until a device is already on the market. In this paper we present a reference model based approach to software conformance checking. Reference models enable the application of formal methods to software conformance checking, and provide a framework for rigorous testing. To illustrate the approach, we develop the reference model for a generic patient controlled Analgesic Infusion Pump, and explain how it can be used to aid software conformance checking in a regulatory environment.

Ban Leong Sng - One of the best experts on this subject based on the ideXlab platform.

  • A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain
    BMC Anesthesiology, 2020
    Co-Authors: Ban Leong Sng, Chin Wen Tan, Nian-lin Reena Han, Rehena Sultana, Daryl Jian’an Tan, Alex Tiong Heng Sia
    Abstract:

    Background We developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) Analgesic Infusion Pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients’ vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia. Methods Nineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 h until assessment of patient satisfaction on the VPIA Analgesic Infusion Pump. Results The primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (

  • A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain.
    BMC anesthesiology, 2020
    Co-Authors: Ban Leong Sng, Daryl Jian An Tan, Chin Wen Tan, Nian-lin Reena Han, Rehena Sultana, Alex Tiong Heng Sia
    Abstract:

    We developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) Analgesic Infusion Pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients’ vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia. Nineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 h until assessment of patient satisfaction on the VPIA Analgesic Infusion Pump. The primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (

  • A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain
    2020
    Co-Authors: Ban Leong Sng, Daryl Jian An Tan, Chin Wen Tan, Nian-lin Reena Han, Rehena Sultana, Alex Tiong Heng Sia
    Abstract:

    Abstract Background: We developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) Analgesic Infusion Pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients’ vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia.Methods: Nineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 hours until assessment of patient satisfaction on the VPIA Analgesic Infusion Pump.Results: The primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (<95%) during the study period. Only 6 (31.6%) patients had oxygen desaturation that persisted for more than 5 minutes. The median percentage time spent during treatment that oxygen saturation fell below 95% was 1.9%. Fourteen (73.7%) out of 19 patients encountered safety pause, due to transient oxygen desaturation or bradycardia. The patients’ median [IQR] pain scores at rest and at movement after post-op 24 hours were 0.0 [2.0] and 3.0 [2.0], respectively. The average morphine consumption in the first 24 hours was 12.5 ± 7.1mg. All patients were satisfied with their experience with the VPIA Analgesic Infusion Pump. Conclusions: The use of VPIA Analgesic Infusion Pump, when integrated with continuous vital sign monitor and variable lockout algorithm, was able to provide pain relief with good patient satisfaction.Keywords: Infusion Pump, postoperative pain, vital sign monitoring, oxygen desaturation.Trial registration: This study was registered on clinicaltrials.gov registry (NCT02804022) on 28 Feb 2016.

  • A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain
    2020
    Co-Authors: Ban Leong Sng, Daryl Jian An Tan, Chin Wen Tan, Nian-lin Reena Han, Rehena Sultana, Alex Tiong Heng Sia
    Abstract:

    Abstract Background: We developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) Analgesic Infusion Pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients’ vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia.Methods: Nineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 hours until assessment of patient satisfaction on the VPIA Analgesic Infusion Pump.Results: The primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (<95%) during the study period. Only 6 (31.6%) patients had oxygen desaturation that persisted for more than 5 minutes. The median percentage time during treatment that oxygen saturation fell below 95% was 1.9%. Fourteen (73.7%) out of 19 patients encountered safety pause, due to transient oxygen desaturation or bradycardia. The patients’ median [IQR] pain scores at rest and at movement after post-op 24 hours were 0.0 [2.0] and 3.0 [2.0], respectively. The average morphine consumption in the first 24 hours was 12.5 ± 7.1mg. All patients were satisfied with their experience with the VPIA Analgesic Infusion Pump. Conclusions: The use of VPIA Analgesic Infusion Pump, when integrated with continuous vital sign monitor and variable lockout algorithm, was able to provide pain relief with good patient satisfaction.Trial registration: This study was registered on clinicaltrials.gov registry (NCT02804022) on 28 Feb 2016.

  • A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain: a case series
    2020
    Co-Authors: Ban Leong Sng, Daryl Jian An Tan, Chin Wen Tan, Nian-lin Reena Han, Rehena Sultana, Alex Tiong Heng Sia
    Abstract:

    Abstract Background We developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) Analgesic Infusion Pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients’ vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia. Methods Nineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 hours until assessment of patient satisfaction on the VPIA Analgesic Infusion Pump. Results The primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (<95%) during the study period. Only 6 (31.6%) patients had oxygen desaturation that persisted for more than 5 minutes. The median percentage time during treatment that oxygen saturation fell below 95% was 1.9%. Fourteen (73.7%) out of 19 patients encountered safety pause, due to transient oxygen desaturation or bradycardia. The patients’ median [IQR] pain scores at rest and at movement after post-op 24 hours were 0.0 [2.0] and 3.0 [2.0], respectively. The average morphine consumption in the first 24 hours was 12.5 ± 7.1mg. All patients were satisfied with their experience with the VPIA Analgesic Infusion Pump. Conclusions The use of VPIA Analgesic Infusion Pump, when integrated with continuous vital sign monitor and variable lockout algorithm, was able to provide pain relief with good patient satisfaction.

Anitha Murugesan - One of the best experts on this subject based on the ideXlab platform.

  • requirements reference models revisited accommodating hierarchy in system design
    IEEE International Conference on Requirements Engineering, 2019
    Co-Authors: Anitha Murugesan, Sanjai Rayadurgam, Mats P E Heimdahl
    Abstract:

    Reference models such as Parnas' four-variable model, Jackson's and Zaves' world machine model, and Gunther et al.'s WRSPM model abstractly define and relate key artifacts in requirements engineering. Such reference models are intended to serve as a frame of reference for engineers to understand and reason about the artifacts involved in requirements engineering. However, when discussing the requirements of modern systems that are developed in a hierarchical and middle-out manner, these reference models do not provide a framework in which the relationship between requirements and architecture is explicitly discussed. Conceptual clarity about this relationship is crucial since the architecture and requirements for such systems become intrinsically intertwined as the architectural choices made during development influence the requirements and vice-versa. Hence, to precisely determine the scope of specifying requirements, distinguish requirements from architecture details, reason about the requirements, and determine how the requirements are realized in the system, we argue that a requirements reference model intended as a reference for such systems must explicitly discuss the architecture - requirements relationship. To that end, we define a hierarchical reference model that formally, yet abstractly, captures the intertwined relationship between the architecture and requirements in a way that will serve the same purpose as other models, but be more suitable for modern systems where architecture and requirements co-evolve. To illustrate the concepts in this model, we use a generic patient-controlled Analgesic Infusion Pump system as a case example.

  • From Requirements to Code: Model Based Development of a Medical
    2016
    Co-Authors: Anitha Murugesan, Mats Heimdahl, Michael Whalen, Sanjai Rayadurgam, John Komp
    Abstract:

    The advanced use of technology in medical devices has improved the way health care is delivered to patients. Unfortunately, the increased complexity of modern medical devices poses challenges for development, assurance, and regulatory approval. In an e ort to improve the safety of advanced medical devices, organizations such as FDA have supported exploration of techniques to aid in the development and regulatory approval of such systems. In an ongoing research project, our aim is to provide effective development techniques and exemplars of system development artifacts that demonstrate state of the art development techniques. In this paper we present an end-to-end model-based approach to medical device software development along with the artifacts created in the process. While outlining the approach, we also describe our experiences, challenges, and lessons learned in the process of formulating and analyzing the requirements, modeling the system, formally verifying the models, generating code, and executing the generated code in the hardware for generic patient controlled Analgesic Infusion Pump (GPCA). We believe that the development artifacts and techniques presented in this paper could serve as a generic reference to be used by researchers, practitioners