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KOLEJ UNIVERSITI TEKNOLOGI TUN HUSSEIN ONN BORANG PENGESAHAN STATUS TESIS* JUDUL: WEB-BASED INTERFACE SYSTEM FOR BEDSIDE MONITOR SESI PENGAJIAN: 2004/2005 Saya KHO YEH YIIAN (HURUF BESAR) mengaku membenarkan tesis (PSM/Saij ana/doktor Falsafah)* ini disimpan di Perpustakaan dengan syarat-syarat kegunaan seperti berikut: 1. 2. 3. 4. Tesis adalah hakmilik Kolej Universiti Teknologi Tun Hussein Onn. Perpustakaan dibenarkan membuat salinan untuk tujuan pengajian sahaja. Perpustakaan dibenarkan membuat salinan tesis ini sabagai pertukaran antara institusi pengajian tinggi. **Sila tandakan {/) 1 SULIT (Mengandungi maklumat yang berdaijah keselamatan atau kepentingan Malaysia seperti yang termaktub di dalam (AKTA RAHSIA RASMI 1972) TERHAD (Mengandungi maklumat TERHAD yang telah ditentukan oleh organisasi/badan di mana penyelidikan dijalankan) 1 V 1 TIDAK TERHAD Disahkan oleh (TANDATANGA^ PENULIS) (TANDAT/ik(MN PENYELIA) Alamat tetap: 18. PERSIARAN 16. PERSIARAN BROOKE, 96000 SIBU. SARAWAK. PROF DR HASHIM BIN SAIM Nama Penyelia Tarikh: 28 MAC 2005 Tarikh: 28 MAC 2005 CATATAN: * Potong yang tidak berkenaan. ** Jika tesis ini SULIT atau TERHAD, sila lampirkan surat daripada pihak berkuasa/organisasi berkenaan dengan menyatakan sekali sebab dan tempoh tesis ini perlu dikelaskan sebagai SULIT atau TERHAD. Tesis dimaksudkan sebagai tesis bagi Ijazah Doktor Falsafah dan Saijana secara penyelidikan, atau disertasi bagi pengajian secara keija kursus dan penyelidikan, atau Laporan Projek Saijana Muda (PSM).

"Saya/Kami akui bahawa saya/kami telah membaca karya ini dan pada pandangan saya/kami karya ini adalah memadai dari segi skop dan kualiti untuk tujuan pengaugerahan Ijazah Saijana Kejuruteraan (Elektrikal)." Tandatangan Nama Penyelia I Tarikh Profesor Dr. HWhim Bin Saim 28 Mac 2005 Tandatangan Nama Penyelia II Tarikh Soon Chin Fhong 28 Mac 2005

WEB-BASED INTERFACE SYSTEM FOR BEDSIDE MONITOR KHO YEH YUAN A thesis submitted in fulfillment of the requirements for the award of the Degree of Master of Engineering (Electrical) Faculty of Electrical and Electronic Engineering Kolej Universiti Teknologi Tun Hussein Onn MARCH, 2005

"No part of the study was covered by copyright. References of information obtained from other source are specially quoted, otherwise the rest of the information presented through this study is the sole work and experimentation carried out by the author" Signature Author KHO YEH YTDLAN Date 28 March 2005

for my beloved parents, brothers and Chee Kiong, may God shower uncountable blessings upon all of you

ACKNOWLEDGEMENT I would like to express my sincere gratitude to Prof. Dr Hashim bin Saim, my supervisor and Mdm Soon Chin Fhong, my co-supervisor for their invaluable guidance and advice throughout this research and all of my work with them and for helping to move this process forward as quickly as possible. I would like to thank Mr. Tang Tung Yan for providing input and advices. My parents have always been a great source of encouragement in believing that I can accomplish whatever I want. For my beloved late brother Yeh Wei, I would also like to thank you for everything. I would like to take this opportunity to thank also my husband, Mr Sia Chee Kiong for his patience with me all this while. In addition, I would like to thank others who have indirectly contributed to the completion of this research such as the medical laboratory technician, Mr. Ahyat for providing help whenever I needed to. And also to all my friends, a big thank you to all of you for being my "patients". There are also many other people that have provided me help and support and one time or another that I should also thank, but the list would grow too long. Many thanks and good luck to everyone.

ABSTRACT From face-to-face consultation to medicine at a distance, technology is changing the way medical services are delivered to the people. We are going into an era where the information is being digitized to be stored in a database. This is done in order to reduce information overlap and redundancy that are the main problems the health care sector are facing right now. More hospitals in other more advanced countries are going paperless. In order to provide better services to the critically ill patients in the ICU or CCU, a data acquisition program is developed for the acquisition of vital signs monitored in the critical care units. This work discusses the work done in extracting the data and signal from patient monitor BSM 8800 to the computer. The data are acquired using RS232C Interface Protocol. The vital signs acquired include oxygen saturation (SaCh), heart rate (HR), electrocardiograph (ECG) signal, non-invasive blood pressure (NIBP), respiration rate (RR), temperature (TEMP) and end tidal carbon dioxide (PETCO2 or ETCO2). Ventricular Premature Contraction (VPC), ST level and arrhythmia information are also acquired and displayed to provide a more thorough information on the condition of the patients. Alarm detection is also programmed so that in critical conditions the vital signs will be displayed in red for extra caution. An ECG user control is designed and embedded in the web page in order to convert and plot the ECG waveform from hexadecimal values sent from the bedside monitor. The user control has been tested its accuracy and proved its validity to reconstruct the original ECG waveform. Basic patient information can also be seen from the graphical user interface (GUI) that has been developed. Physicians and medical practitioners have to register with the system before gaining access to the system and only the physician-in-charge of the patient can see the more intricate details of the patient.

ABSTRAK Teknologi sedang mengubah cara peijumpaan pesakit dengan doktor secara konvensional kepada cara rawatan dari lokasi lain sedikit demi sedikit. Kita sedang menuju ke era di mana maklumat ditukar kepada bentuk digital untuk disimpan dalam pangkalan data. Ini adalah bertujuan mengurangkan informasi dan maklumat yang sama difailkan dua kali. Sektor perubatan kini sedang menghadapi masalah perlapisan data serta data lapuk yang tidak dikemaskinikan. Hospital di negaranegara maju telahpun lama mengaplikasikan cara penyimpanan rekod secara digital untuk mengelakkan pembaziran kertas. Bagi memberikan rawatan yang lebih baik kepada pesakit-pesakit di unit-unit kecemasan, satu program untuk mendapatkan data pesakit untuk pemeriksaan doktor dan jururawat dibangunkan. Tesis ini membincangkan keija yang dibuat untuk mendapatkan data tersebut daripada BSM 8800 kepada komputer. Data didapatkan melalui protokol RS232C yang membolehkan komunikasi antara alatan dengan komputer. Data yang didapatkan termasuk kepekatan oksigen (Sa02 atau Sp0 2 ), kadar denyutan (HR), elektrocardiograf (ECG), tekanan darah (NIBP), kadar respirasi (RR), suhu badan (TEMP) dan kepekatan karbon dioksida dalam darah (ETC0 2 atau PETC0 2 ). Kontraksi ventrikel awalan (VPC), tahap ST dan maklumat mengenai ECG yang tidak normal turut didapatkan bagi mengetahui keadaan pesakit yang lebih menyeluruh. Di kala teijadinya kecemasan, data akan terpapar dalam warna merah. Satu program bagi menukarkan maklumat dalam bentuk heksa kepada voltan ECG yang sepatutnya dibangunkan. Ia diuji dalam ketepatannya dan terbukti bahawa ianya boleh dipercayai untuk menghasilkan gelombang ECG yang sama seperti yang sebenar. Maklumat mengenai pesakit serta doktor yang merawat terdapat dalam laman web yang dihasilkan. Doktor haruslah mendaftarkan diri sebelum boleh mengakses laman web tersebut. Hanya doktor yang bertanggungjawab terhadap seseorang pesakit boleh membaca maklumat pesakit yang lebih terperinci.

CONTENTS CHAPTER ITEM PAGE TITLE PAGE TESTIMONY DEDICATION ACKNOWLEDGEMENT PAPERS PUBLISHED ARISING FROM THIS WORK ABSTRACT ABSTRAK CONTENTS LIST OF TABLES LIST OF FIGURES LIST OF ABBREVIATIONS LIST OF APPENDICES i ii iii iv v vi vii viii xiii xv xvii xix I INTRODUCTION 1.1 Background 1 1.2 Definition of Tide 3 1.3 Problem Statement 4 1.4 Objectives 6 1.5 Scope of Work 6 1.6 Proposed Method 12 1.7 Thesis Organization 12

II AN OVERVIEW OF VITAL SIGNS MONITORED IN ICU/CCU 2.1 Vital Signs in the ICU/CCU 14 2.2 Electrocardiograph 14 2.3 Pulse / Heart Rate 18 2.4 Oxygen Saturation 18 2.5 Respiration Rate 19 2.6 End Tidal Carbon Dioxide 19 2.7 Non Invasive Blood Pressure 21 2.8 Temperature 22 2.9 ST Level and Ventricular Premature 23 Contraction 2.10 Brief Overview of the Conditions in ICU/CCU 24 2.11 Conclusion 26 III REVIEW OF LITERATURES 3.1 Introduction to Telemedicine 27 3.2 Wireless Technologies 31 3.3 Components in Telemedicine Applications 36 3.3.1 Computer Based Records and Critical 36 Care Databases 3.3.2 User Interface 41 3.3.3 Systems Integration and Standards 42 3.3.4 Telemedicine Architecture 43 3.4 Requirements for Web-based Systems 43 3.4.1 Requirements to Information Security 44 3.4.2 Requirements to Communication 45 Technology 3.5 Related Works 47 3.6 Telemedicine Assessment 51 3.7 Summary 53

IV METHODOLOGY 4.1 Introduction 55 4.2 Programming Languages and Tools Used in 63 Project Development 4.2.1 Visual Basic 6 (VB6) 63 4.2.2 SoftWIRE Technology 64 4.2.3 Active Server Pages 64 4.2.4 Structured Query Language (Sequel or 66 SQL) 4.2.5 MS Access 97 66 4.2.6 ActiveX Technology 67 4.3 Data Acquisition from Patient Monitor Unit 69 4.3.1 BSM 8800 RS232C Cable 69 4.3.2 RS232C Interface Protocol for Patient 69 Monitoring System 4.3.3 Visual Basic Communication Tool 70 4.3.4 ECG Waveform Sequential Data 73 Acquisition 4.3.5 Other Vital Signs Data Acquisition 76 4.3.6 Non-Invasive Blood Pressure Data 78 Acquisition 4.4 Patient Database Development 78 4.4.1 Introduction 78 4.4.2 Patient Database Fields Determination 79 4.4.3 Unnormalized Form 80 4.4.4 First Normal Form 81 4.4.5 Second Normal Form 82 4.4.6 Third Normal Form 82 4.4.7 Data Dictionary 83 4.5 Web Pages Development 84 4.5.1 Basic Interface Design 84 4.5.2 Coding With ASP 84 4.5.3 Creating an ActiveX Control for ECG 84

Graph 4.5.4 Data Extraction of the Vital Signs 86 4.5.5 Testing the Program and Web Pages 89 4.6 Project Specification Summary 89 4.7 Conclusion 91 V RESULT ANALYSIS AND DISCUSSIONS 5.1 Introduction 92 5.2 VB Communication Tool Results 92 5.3 Web-based Interface System Screen Captures 94 5.4 MS Access Database 115 5.5 Configuring ns5 115 5.6 Validation of the ECG Graph Control 116 5.6.1 Validation Using Simulated ECG 116 Signals in Non-noisy Environment 5.6.2 Validation Using Simulated ECG 123 Signals in Noisy Environment 5.6.3 Simulated ECG Signals Analysis 130 Results 5.6.4 Validation Using Real Patient ECG 137 Signals 5.6.5 Real Patient ECG Signals Analysis 142 Results 5.7 Other Vital Signs Validation 144 5.8 Conclusion 146 VI CONCLUSION AND FUTURE DEVELOPMENT 6.1 Research Summary 147 6.2 Conclusion 148 6.3 Suggestion For Future Development 148

REFERENCES 150 APPENDIX A-O 161-277

LIST OF TABLES TABLE TITLE PAGE 2.1 Electrode Positions and Connections for Standard ECG 16 Leads 2.2 Difference between Normal and Abnormal Capnogram 20 2.3 Description of Different Phases of A Capnogram 20 2.4 Functions of the Intensive Care Complex 25 3.1 Wireless Connectivity Technologies 33 3.2 Challenges of Creating Critical Care Databases 39 3.3 Reasons for Slow Adoption of New Signal Processing 40 Method 3.4 Measures Taken to Protect Patient Data 44 3.5 Important Aspects in Telemonitoring Applications 48 4.1 Main Components in Access 97 67 4.2 Code to Send and Receive Data Continuously from Patient 71 Monitor 4.3 Coding to Send Request Out from PC 73 4.4 Waveform Information Sequential File Summary 74 4.5 Format Summary of ECG Waveform Sequential Line 74 4.6 Example of Numerical and Alarm Data 77 4.7 Database Normalization Reasons 79 4.8 Unnormalized Form 80 4.9 First Normal Form 81 4.10 Second Normal Form 82 4.11 Third Normal Form 83 4.12 Procedures for Creating an ActiveX Control 86 4.13 Project Specification Summary 89

5.1 Numerical and Alarm Data Output 108 5.2 Network Connection Settings 116 5.3 Comparison Table for Normal Sinus Rhythm 117 5.4 Comparison Table for Asynchronous Waveform 118 5.5 Comparison Table for Second Degree Block 118 5.6 Comparison Table for Left Bundle Branch Block 119 5.7 Comparison Table for Right Bundle Branch Block 120 5.8 Comparison Table for Atrial Flutter 120 5.9 Comparison Table for AV Sequential 121 5.10 Comparison Table for Nodal Rhythm 121 5.11 Comparison Table for Supraventricular Tachycardia 122 5.12 Comparison Table for PVC 24 min 123 5.13 Comparison Table for Normal Sinus Rhythm With Noise 124 5.14 Comparison Table for Asynchronous Waveform With 124 Noise 5.15 Comparison Table for Second Degree Block With Noise 125 5.16 Comparison Table for Left Bundle Branch Block With 126 Noise 5.17 Comparison Table for Right Bundle Branch Block With 127 Noise 5.18 Comparison Table for Atrial Flutter With Noise 127 5.19 Comparison Table for AV Sequential With Noise 128 5.20 Comparison Table for Nodal Rhythm With Noise 128 5.21 Comparison Table for Supraventricular Tachycardia With 129 Noise 5.22 Comparison Table for PVC 24 min With Noise 130 5.23 Comparison Table for Male A 137 5.24 Comparison Table for Male B 138 5.25 Comparison Table for Male C 139 5.26 Comparison Table for Female D 139 5.27 Comparison Table for Female E 140 5.28 Comparison Table for Female F 141 5.29 Testing the Validation of Other Vital Signs Display 144

LIST OF FIGURES FIGURE ITEM PAGE 1.1 Total Hospital Information System Concept 9 1.2 Integration Concept for Monitoring 8 1.3 Scope of Project 10 1.4 Overall System Architecture of Proposed Monitoring 13 System 2.1 A Typical ECG Waveform 15 2.2 Einthoven's Triangle 17 2.3 Normal Capnogram 20 4.1 Overall System Setup 55 4.2 Aloka SSD-200 Ultrasound System 56 4.3 Stryker Endoscopy Model 688i 57 4.4 Other Equipments That Are Switched On 57 4.5 Flow Chart of Data Acquisition and Display 59 4.6 Patient Database Web Page Development Flow Chart 60 4.7 Web Page Program Flow 61 4.8 Entry Drop Down Menu 62 4.9 Reports List 62 4.10 Tools List 62 4.11 A COM Object 68 4.12 Basic Interface Design 70 4.13 ECG Waveform Sequential Files 75 4.14 Basic Web Page Interface Design 85 5.1 VB Communication Tool Interface 93 5.2 Login Interface 94 5.3 New User Registration Interface 95

5.4 Overview of the System Developed 96 5.5 Patient Details Summary Page 97 5.6 Enter Patient Information Page 97 5.7 Deleting a Patient Record 98 5.8 Searching Through Records Using Patient Name 98 5.9 Results of Search Using Patient Name 99 5.10 Searching Through Records Using Patient Code 99 5.11 Results of Search Using Patient Code 100 5.12 Physician Details Entry Form 101 5.13 Physician Summary Page and Search Using Physician 101 Name 5.14 Results of Search Using Physician Name 102 5.15 Results of Search Using Physician Code 103 5.16 List of Patients Registered in the System 103 5.17 Admit New Patient Under Physician's Own Account 104 5.18 Patient Examinations for Physician Sam Mokhtar 105 5.19 Examination Types 106 5.20 Others Examination Type 106 5.21 Examination and Findings Report 107 5.22 Patient ICU Findings and Exams 107 5.23 Search Unreleased Patients According to Date of 109 Admission 5.24 Discharge Patient Interface 109 5.25 Released Patients List 110 5.26 Reports Generated By System 110 5.27 Print Patient List HI 5.28 Patient Code List Report 111 5.29 Daily Admission List According to Date 112 5.30 Daily Admission Report 1 12 5.31 List of Released Patients According to Date 113 i 5.32 Released Patients Report 113 5.33 Useful Links to Other medical Websites 114 5.34 About the System 114 5.35 MS Access 97 Database Tables 115

LIST OF ABBREVIATIONS ADO ActiveX Data Object ASCII American Standard Code for Information Interchange ASF Active Server Pages AV Atrioventricular CCS Critical Care System CCU Coronary Care Unit CIS Clinical Information System COM Component Object Model CPR Computer Patient Record CTI Computer Telephone Integrated DCOM Distributed COM DICOM Digital Imaging and Communications in Medicinc DSL Digital Subscriber Line ECG Electrocardiograph EEG Electroencephalograph EHR Electronic Health Record EMG Electromyograph EMR Electronic Medical Record ETCO2 or PETCO2 - End Tidal Carbon Dioxide GUI Graphical User Interface HIS Hospital Information System HL7 Health Level 7 HR Heart Rate IBP Invasive Blood Pressure ICT Information and Communications Technology ICU Intensive Care Unit ns Internet Information Services

IOM - Institute of Medicine ISDN - Integrated Services Digital Network IT - Information Technology JScript - Java Script Lab VIEW - Laboratory Virtual Instrumentation Engineering LAN - Local Area Network LIS - Laboratory Information System NIBP - Non-Invasive Blood Pressure PaCC>2 - Partial Pressure of Carbon Dioxide PACS - Picture Archiving and Communication System PC - Personal Computer PDA - Personal Digital Assistant PICIS - Patient Integrated Clinical Information System PIS - Pharmacy Information System PM - Patient Monitor PVC - Premature Ventricular Contraction PWS - Personal Web Server RIS - Radiology Information System RR - Respiration Rate RW - Reconstructed Waveform SA - Sino-atrial Sa(>2 or - Oxygen Saturation Sp0 2 SC - Strip Chart TEMP - Temperature USB - Universal Serial Bus VB - Visual Basic VI - Virtual Instruments VPC - Ventricular Premature Contraction INF - First Normal Form 2NF - Second Normal Form 3NF - Third Normal Form

LIST OF APPENDICES APPENDIX ITEM A B C D E F G H I J K L M N O An Email Feedback from Dr. Poh Yih Jia An Email Feedback from Dr. Yek Kiung Wei A Testimony from Dr. Zulkifli bin Taat RS232C Communication Method RS232C Operating Mode Numerical Data and Waveform Communication Protocol ECG Output Voltage Conversion Table Web Page Data Elements and Data Dictionary Program Breakdown of Vital Signs Display and ECG Waveform Internet Information Services (IIS5) Setup Procedures Software Compatibility Vital Signs Information Results and Charts Our Heart

CHAPTER I INTRODUCTION 1.1 Background In the Intensive Care Unit (ICU) or Coronary Care Unit (CCU) and other critical care settings, patients' physiological state needs to be monitored at all times but medical staff do not have the human resources and technical capabilities to perform this task continuously. Ever since the technology of monitoring astronauts' vital signs in space was transferred to the bedside in the 1960s, patient monitoring systems have become an essential part of critical care [ 1 ]. Today, these systems can gather multiple physiological signals simultaneously and derive clinically important parameters. Many monitoring systems are geared towards remote monitoring of patients' physiological signals. Although the amount of information patient monitoring systems provide to medical practitioners is more than ever before and still improving, the usability and usefulness of the information is less than desirable. The raw data contains measurement errors and noise from biosensors. Corrections for these errors and elimination of noise have to be done for better accuracy of the signals and data acquired. Data integration and multi-parameter data analysis might be able to extract useful information from the imperfect raw data, but the state-of-the-art monitoring systems carried out limited data integration and analysis for effective decision support. Therefore, many manufacturers are improving their products constantly, hoping to give more satisfaction and functionality to the practitioners.

One symptom of this lack of data integration and analysis is the lack of electrocardiograph (ECG) signal analysis. Patient monitors located at the patients' bedside are able to monitor their ECG signals. However, physicians are unable to determine the voltage levels of the P, Q, R, S, and T points of the ECG without the waveform printouts. The same problem also arises for the R-R intervals. In order to solve these, researchers have been creating web-enabled software to allow the analysis of the ECG waveform and the peak detection features. The ability to monitor the patient remotely is an added value for the physicians so that they do not have to be always on site whenever they want to know their patients' conditions. Other than wired applications using landlines, researchers from other parts of the world are also looking into wireless and mobile applications for remote monitoring systems. There is little doubt that mobile computing can be a powerful tool to reengineer business processes. The benefits of such reengineering include reduced paper handling, reduced travel, improved data accuracy and timeliness, and reduced need for large central office facilities. Nevertheless, one particularly difficult issue for wireless communications is security. For instance, some wireless technologies are not suitable for applications in which sensitive client information is exchanged between a central database and a remote device because the data signal can be intercepted [2]. Wireless communication is often ruled out due to cost or simply not feasible. In some cases, mobile computing must rely on replication and synchronization of data over landlines. Therefore, it is important to balance the initial and ongoing costs of implementing these technologies, including training and support, against the potential benefits of time and monetary savings. Before proceeding further into the discussion of the research, section 1.2 will first define the terms of web-based interface system for better understanding the rest of the discussion in this thesis.