Electrocardiography
Conditions
Brief summary
The objective of the study is to compare electrocardiograms using ambulatory holter monitor with dry electrodes in a harness versus using an ambulatory holter with standard sticky electrodes (Red Dot) on monitored patients within the hospital. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour. One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived.
Interventions
DEVICEElectrocardiogram holter
Sponsors
University of Toledo Health Science Campus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient within the hospital either for procedure or for admission
Exclusion criteria
* Patients who cannot wear a Holter monitor * Patients undergoing an MRI or have other contraindications for wearing an ambulatory Holter monitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrythmia | 15 minutes | quality of data obtained between harness and holter. Subjective evaluation: -Quality of the data will be rated on a 0 - 10 scale with 0 being unreadable and 10 being excellent |
Countries
United States
Participant flow
Recruitment details
recruitment was done in the hospital setting with patients that were admitted. start of enrollment was 3/26/2013-3/9/15.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Electrocardiograms Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour.
One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned.
Electrocardiogram holter | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Patients With Electrocardiograms |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 74.6 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Arrythmia
quality of data obtained between harness and holter. Subjective evaluation: -Quality of the data will be rated on a 0 - 10 scale with 0 being unreadable and 10 being excellent
Time frame: 15 minutes
Population: there were 13 females and 7 males, mean age of 74.65
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Electrocardiograms | Arrythmia | harness | 4.6 Quality rating | Standard Deviation 2.30332 |
| Patients With Electrocardiograms | Arrythmia | holter | 7.95 Quality rating | Standard Deviation 1.877715 |