Clinical trial NCT01913561: The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection
Official title: The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection Compared To Standard Gel-Electrode-Based ECG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Keywords: Electrocardiogram
gel electrodes
textile electrodes
Lead sponsor: HealthWatch Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Eligibility criteria: Inclusion Criteria:

* Age\>18 years.
* Suspected for arrhythmia or have evidence of arrhythmia disorder.
* Needs continuous, in-hospital ECG monitoring.
* Ability to give informed consent.

Exclusion Criteria:

* Patients with known allergy to silver.
* Patients with recent trauma to chest wall.
* Pregnant or lactating woman.
* Patients with chest deformity precluding placement of the garment.
* Patients participating in another ongoing trial.

Primary outcomes:
measure: From the ECG record collect the Heart Rate HR.
timeFrame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
measure: From the ECG record collect the P Wave width (sec.) and the amplitude (mV).
timeFrame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
measure: From the ECG record collect the QRS Complex width (sec.) and the amplitude (mV).
timeFrame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
measure: From the ECG record collect the T Wave width (sec.) and the amplitude (mV).
timeFrame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
measure: From the ECG record collect the RR Interval width (sec.).
timeFrame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
measure: From the ECG record collect the PR Interval width (sec.).
timeFrame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
measure: From the ECG record collect the QT Interval width (sec.).
timeFrame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center
Study officials:
affiliation: Rambam medical center Haifa, Israel
name: Robert Zukerman, Dr.
role: PRINCIPAL_INVESTIGATOR
References: