The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection
Condition: Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      The Master Caution Garment is embedded with 10/13 textile dry electrodes that enable
      12/15-lead ECG.

      The electrodes are dry, textile ECG electrodes. The garment is designed to position the
      electrodes in the appropriate anatomical locations, without any special guidance. The dry
      electrodes are made from unique yarns with silver embedded into the garment using a
      proprietary technique developed by HealthWatch (HW)that obviates the need for skin
      preparation or the application of fluids. The garment can be connected to any standard ECG
      device available in the hospitals.

      The purpose of this study is to evaluate the safety and effectiveness of the Master Caution
      Garment for continuous monitoring of ECG signal compared to standard gel electrodes.

      The following endpoints will be evaluated in subjects participating in the study:

      Primary:

      Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes
      using standard ECG devices.

      Secondary:

      Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes
      when event is detected by the ECG devices.
    

Detailed description: 
      Part A - ECG in Rest

        1. In the beginning of the study, the following parameters will be measured and documented
           in the CRF: blood pressure, body temperature, respiratory rate and oxygen saturation in
           the blood.

        2. The patient will be dressed with the Master Caution Garment and connected to a 12 lead
           ECG device. The procedure takes 5 minutes including data printing.

        3. A twelve lead ECG with gel electrodes will be done and data printed. The procedure takes
           5 minutes. The patient will stay connected to the monitor for the following hour.

        4. After an hour the data from the gel electrodes will be printed again.

        5. The patient will be dressed again with the Master Caution Garment and connected to a 12
           lead ECG device. The procedure takes 5 minutes including data printing.

        6. The following parameters will be compared between the gel ECG and the Garment ECG:

             -  Heart Rate (HR)

             -  P wave width and amplitude

             -  QRS complex width and amplitude

             -  T wave width and amplitude

             -  RR interval

             -  PR interval

             -  QT interval

      Part B - ECG in motion

        1. In the beginning of the study, the following parameters will be measured : blood
           pressure, body temperature, respiratory rate and oxygen saturation in the blood.

        2. Four (4) gel electrodes will be placed on the patient on the following places - Left Arm
           (LA), Right Arm (RA), Left Leg (LL) and Right Leg (RL).

        3. The patient will be dressed with the Master Caution Garment (MCG)on the 4 gel electrodes
           that were already placed.

        4. The same 4 electrodes in the garment LA, RA, LL and RL will be connected to a standard
           of care ECG device.

        5. The 4 gel electrodes will be connected to a standard of care ECG device.

        6. The ECG devices will be recording the ECG signal from the two sets of electrodes for 24
           hours.

           Every hour in the first 6 hours the data will be printed from both devices. In every
           event detected the data will be printed from both devices. the data will be evaluated
           for quality comparison between the gel and the textile electrodes using the hospital ECG
           device.

        7. In first 6 hours for every hour and for each event detected by either the gel electrodes
           or the MCG textile electrodes the following parameters shell be evaluated at the end of
           the study from the hospital ECG printouts for the Master Caution Garment and for the gel
           electrodes:

             -  Heart Rate (HR)

             -  P wave width and amplitude

             -  QRS complex width and amplitude

             -  T wave width and amplitude

             -  RR interval

             -  PR interval

             -  QT interval After first 6 hours for each event detected by either the gel
                electrodes or the MCG textile electrodes the above mentioned parameters shell be
                evaluated at the end of the study from the hospital ECG printouts for the Master
                Caution Garment and for the gel electrodes.

      The goal of the current study is to evaluate the safety of the MCG and compare ECG signals
      from the Master Caution Garment with the ECG signals from gel electrodes.

      This is a prospective, comparative study.

      For each time interval and each event detected by the ECG devices, the analysis will
      determine its category as follows:

        1. Blinded cardiologist's assessment whether at that time interval the patient suffered
           from a disorder. This assessment will be based on hospital's recorded data with the gel
           electrodes.

        2. The Master Caution Garment result for that time interval will be categorized as follows:

             -  True Positive (TP) = MCG Alert was right (based on GS)

             -  False Positive (FP) = MCG Alert was wrong

             -  True Negative (TN) = No MCG Alert when indeed alert was not necessary

             -  False Negative (FN) = No MCG Alert but there was a disorder case
    

Intervention name(s): Master Caution Garment; ECG gel electrodes
Intervention type(s): Device; Device
Intervention description(s): Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG.
The electrodes are dry, textile ECG electrodes.; Standard gel electrodes that are been in use in hospital for ECG monitoring.
Other intervention name(s): MCG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Electrocardiogram; gel electrodes; textile electrodes