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An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry

An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04227418
Enrollment
1500
Registered
2020-01-13
Start date
2020-01-24
Completion date
2021-08-31
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Dementia, Mental Health Disorder

Brief summary

Acetylcholinesterase inhibitors and antipsychotics are drugs commonly prescribed in psychiatry, the former for dementia and the latter for acute and chronic psychotic illness. Both can cause cardiac arrhythmia therefore 12 lead ECG's are recommended before prescribing. The test is often difficult to obtain however, leading to either patients being inconvenienced or drugs prescribed without the test. There are two parts of this study, but both examine the utility of single lead ecg monitoring, one in the memory clinic and the other in inpatient psychiatry wards. The aim to to evaluate the safety and efficacy of the handheld ecg versus the 12 lead and 6 lead ecg, and whether the handheld ecg can be used to screen for ecg abnormalities that would generally lead to a caution or contra-indication for acetylcholinesterase inhibitors and anti-psychotic medication. Patients will either be recruited from the outpatient memory clinic or in patient psychiatry wards. Following informed consent baseline demographic data will be collected, and patients will undergo a 12 lead and 6 lead ECG as well as a rhythm strip using the handheld device. Data from this point will be annonymised for future analysis. The psychiatrists ECG report will also be recorded, and a subset of patients will undergo an echocardiogram (to see what proportion of patients with psychiatric disorders have structural heart disease.)

Interventions

DEVICE12 lead ECG monitoring

Rate, Rhythm, QTc and PR interval will be assessed

DEVICE6 lead ECG monitoring

Rate, Rhythm, QTc and PR interval will be assessed

DEVICEHand held ECG monitoring

Handheld ECG machines are portable, inexpensive, hand held devices that provide a 'real-time' rhythm strip, equivalent to lead I or II on a 12 lead machine, depending on how the device is held. The rhythm strip is displayed on a computer tablet or mobile phone, and are compatible with both android and iPhone platforms. To perform the test the patient places their fingers/thigh, or alternatively the device can be placed directly on the patient's chest. The process does not require the patient to be exposed, can be done in a seated position (negating the need an examination couch) and their ease of use and portability means they could be readily used in memory clinics or community settings.

Sponsors

Leeds and York Partnership NHS Foundation Trust
CollaboratorOTHER_GOV
The Leeds Teaching Hospitals NHS Trust
Lead SponsorOTHER

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 attending the memory clinic Any patient admitted to the acute psychiatric ward requiring antipsychotic medication

Exclusion criteria

Patients who lack capacity and do not have a personal consultee to provide assent

Design outcomes

Primary

MeasureTime frameDescription
ECG monitoring45 minutes12 lead, 6 lead and handheld ECG device monitoring will be undertaken.

Countries

United Kingdom

Contacts

Primary ContactMuzahir Tayebjee
muzahir.tayebjee@nhs.net+441133926619

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026