NCT04723654

Brief Summary

The purpose of this study is to develop biocompatible wireless electronic devices that will allow continuous, non-invasive hemodynamic and physiology measurements in the ICU.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

7.8 years

First QC Date

January 13, 2021

Last Update Submit

November 25, 2024

Conditions

Prematurity

Keywords

Blood PressureVital SignsWireless Monitoring

Outcome Measures

Primary Outcomes (1)

  • Continuous non-invasive BP monitoring

    Recorded measurements of BP as compared to the ICU standard of care monitoring, including both arterial line measurements and cuff-based measurements of the arm (mm Hg).

    up to 48 hours

Secondary Outcomes (1)

  • Accuracy of Other Physiologic Signals

    up to 48 hours

Study Arms (2)

ICU Population

Patients admitted to one of 3 ICUs at Lurie Childrens

Device: Wireless Wearable Vital Sign Monitor

Non-ICU Population

Healthy volunteers who are under 18 years of age, whose parents consent to their participation, and who are willing to visit CAMP for a one time study visit can participate in this study.

Device: Wireless Wearable Vital Sign Monitor

Interventions

Wireless Wearable Vital Sign MonitorDEVICE

Placement of wireless wearable vital sign monitors on patients limbs for up to 48 hours

ICU PopulationNon-ICU Population

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to one of 3 ICUs at Lurie Children's, or healthy volunteers visiting CAMP at Lurie Children's

You may qualify if:

  • Admitted to one of the four ICUs at Lurie Children's or Prentice Women's Hospital
  • Under 18 years of age
  • Under 18 years of age
  • Willing to visit the Center for Autonomic Medicine in Pediatrics (CAMP) for a one time study visit

You may not qualify if:

  • A skin abnormality that would potentially increase the risk of device
  • years of age or older
  • Determined by an attending physician or bedside care team to be too unstable (patient) or experiencing too much stress (family)
  • A skin abnormality that would potentially increase risk of device use
  • years of age or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (2)

  • Chung HU, Rwei AY, Hourlier-Fargette A, Xu S, Lee K, Dunne EC, Xie Z, Liu C, Carlini A, Kim DH, Ryu D, Kulikova E, Cao J, Odland IC, Fields KB, Hopkins B, Banks A, Ogle C, Grande D, Park JB, Kim J, Irie M, Jang H, Lee J, Park Y, Kim J, Jo HH, Hahm H, Avila R, Xu Y, Namkoong M, Kwak JW, Suen E, Paulus MA, Kim RJ, Parsons BV, Human KA, Kim SS, Patel M, Reuther W, Kim HS, Lee SH, Leedle JD, Yun Y, Rigali S, Son T, Jung I, Arafa H, Soundararajan VR, Ollech A, Shukla A, Bradley A, Schau M, Rand CM, Marsillio LE, Harris ZL, Huang Y, Hamvas A, Paller AS, Weese-Mayer DE, Lee JY, Rogers JA. Skin-interfaced biosensors for advanced wireless physiological monitoring in neonatal and pediatric intensive-care units. Nat Med. 2020 Mar;26(3):418-429. doi: 10.1038/s41591-020-0792-9. Epub 2020 Mar 11.

    PMID: 32161411BACKGROUND

  • Chung HU, Kim BH, Lee JY, Lee J, Xie Z, Ibler EM, Lee K, Banks A, Jeong JY, Kim J, Ogle C, Grande D, Yu Y, Jang H, Assem P, Ryu D, Kwak JW, Namkoong M, Park JB, Lee Y, Kim DH, Ryu A, Jeong J, You K, Ji B, Liu Z, Huo Q, Feng X, Deng Y, Xu Y, Jang KI, Kim J, Zhang Y, Ghaffari R, Rand CM, Schau M, Hamvas A, Weese-Mayer DE, Huang Y, Lee SM, Lee CH, Shanbhag NR, Paller AS, Xu S, Rogers JA. Binodal, wireless epidermal electronic systems with in-sensor analytics for neonatal intensive care. Science. 2019 Mar 1;363(6430):eaau0780. doi: 10.1126/science.aau0780.

    PMID: 30819934BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Susan Slattery, MD

CONTACT

312-227-3300sslattery@luriechildrens.org

Casey Rand, MDS

CONTACT

312-227-3300crand@luriechildrens.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 26, 2021

Study Start

March 15, 2018

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations

US(2)