In-Hospital Cardiac Arrest
Conditions
Keywords
In-Hospital Cardiac Arrest, Telemetry
Brief summary
This study will obtain device-human interaction evaluations for the HWD1000 within the controlled environment of the hospital as well as establish that the safety profile is similar to outpatient wearable cardioverter-defibrillators use.
Detailed description
A multi-center prospective study of hospitalized patients whom a physician deems at risk of sudden cardiac arrest during the hospitalization period, wearing the HWD1000 hospital wearable defibrillator in order to evaluate caregiver and patient interactions with the device. In addition, ECG signal quality will be reviewed to confirm the HWD1000 safety profile.
Interventions
DEVICEHWD1000
Wearable cardioverter-defibrillator designed for inpatient use
Sponsors
Zoll Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients whom a physician deems at risk of sudden cardiac arrest during the hospitalization period (patients will be monitored using the hospital's telemetry system). Specific inclusion criteria are: * Hospitalized patients having continuous independent ECG monitoring. * Patients at risk of sudden cardiac arrest during the hospitalization period as determined by the investigating physician. * Patient ≥18 years of age (over the legal age of providing consent).
Exclusion criteria
* Patients with an active implantable cardioverter-defibrillator. * Patients with an active unipolar pacemaker. * Patients with physical or mental conditions preventing them from interacting with or wearing the device as determined by the investigating physician. * Patients having an advanced directive prohibiting resuscitation. * Patients having bandages or other clinical condition preventing the HWD use. * Patients unable to consent. * Patients having recently experienced an arrhythmic storm. * Patients prone to paroxysmal supraventricular tachycardia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise. | 24 hours or longer | The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HWD1000 Subjects using HWD1000
HWD1000: Wearable cardioverter-defibrillator designed for inpatient use | 59 |
| Total | 59 |
Baseline characteristics
| Characteristic | HWD1000 |
|---|---|
| Age, Continuous | 55.5 Years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 59 |
| other Total, other adverse events | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 |
Outcome results
Primary
Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.
The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours).
Time frame: 24 hours or longer
Population: Subjects who wore the HWD 1000 for a minimum of 24 hours.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HWD1000 | Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise. | Neither lead used for monitoring | 0.53 percentage of time worn | Standard Deviation 0.73 |
| HWD1000 | Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise. | One lead not used for monitoring | 2.54 percentage of time worn | Standard Deviation 3.16 |