The Efficacy of a Novel, Non-contact EKG in the NICU

Electrocardiogram Electrode Site Reaction Clinical Trial

Official title:

The Efficacy of a Novel, Non-contact EKG in the NICU

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04269044
• Other study ID #: 20-006-LFH
• Status: Not yet recruiting
• Start date: March 15, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Northwestern Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We will be comparing a novel, non-contact EKG waveform and heart rate to the standard of care, contact-based EKG waveform and heart rate in neonates, who have sensitive skin.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 30 Days

Eligibility

Inclusion Criteria:

• Apgar at 5 min >/= 7

• Admitted to the NICU

• Indication for standard EKG monitoring

Exclusion Criteria:

• Apgar < 7 at 5 min

• Not in the NICU

• Not being monitored with standard EKG monitors

Related Conditions & MeSH terms

• Electrocardiogram Electrode Site Reaction

Intervention

Diagnostic Test:
• non-contact EKG
ultra-sensitive, non-contact EKG pad will be placed beneath the infant

Locations

Country	Name	City	State
United States	Northwestern Lake Forest Hospital	Lake Forest	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in heart rate	we will compare the two heart rate figures from both EKG sources	1 hour