Advanced Multimodal Wireless Vital Signs Monitoring for Patients With Asthma and Anaphylaxis

NCT04360213 | Completed

• 1 other identifier: 2020-3403
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the function and reliability of a non-invasive, skin-like electronic sensor. We hypothesize that this skin sensor will address an unmet need to wirelessly, noninvasively, and rapidly assess critical vital signs and other measures essential to healthcare monitoring for patients with asthma and anaphylaxis.

Conditions

Asthma in Children; Allergy

Outcome Measures

Primary Outcomes (1)

• Percent agreement with pilot sensor and current standard

  2 years

Secondary Outcomes (2)

• Capture of patient feedback examining opinions on use of wearable sensors compared to standard of care devices.(Allergy patients)

  2 years

• Capture of patient feedback examining opinions on use of wearable sensors compared to standard of care devices.(Asthma patients)

  2 years

Study Arms (2)

Children with Asthma

1. Patients ages 1 to 17 years old 2. Patients in the Emergency Department or admitted to the hospital for asthma exacerbation.

Device: Advanced multimodal wireless vital signs monitor

Children with allergy

1. Patients ages 1 to 17 years old 2. Patients scheduled to do an oral food challenge

Device: Advanced multimodal wireless vital signs monitor

Interventions

Advanced multimodal wireless vital signs monitor DEVICE

Investigators have developed a lightweight, stretchable 'skin-like' membranes, called skin sensors. These small, paper-thin monitors were created by matching the mechanical properties of skin, and can be applied to the skin's surface without skin disturbance. Each patch is encapsulated using medical grade materials and applied using single use medical grade skin adhesive integrated with eco-fused fabric (moisture wicking layer between adhesives). The adhesive may be changed between uses, and the device itself can be cleaned with Super Sani-Cloth®, commonly used in the hospital setting.

Children with Asthma; Children with allergy

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children scheduled to come to the hospital or admitted into Emergency Department for allergy testing, anaphylaxis or asthma exacerbations.

You may qualify if:

• Patients ages 1 to 17 years old
• Patients scheduled to do an oral food challenge or managed in the ED or admitted to the hospital for asthma exacerbation.
• For exploratory analyses of breath sounds, patients in the ED with signs and symptoms of lower respiratory tract infection (e.g., bronchiolitis, pneumonitis, pneumonia).

You may not qualify if:

• \. Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed (including wounds, blistering, cracked or peeling skin, burns or skin that is bandaged/covered)

Sponsors & Collaborators

• Northwestern University: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611-2991, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 24, 2020
• Study Start: June 1, 2021
• Primary Completion: August 16, 2021
• Study Completion: September 2, 2022
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

US (1)