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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360213
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Shuai (Steve) Xu, Northwestern University

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.


Condition or disease Intervention/treatment
Asthma in Children Allergy Device: Advanced multimodal wireless vital signs monitor

Detailed Description:

In clinical and home settings sensors to monitor vital parameters (including heart rate, ECG, respiratory rate, temperature, and pulse oximetry) require the application and removal of multiple, often bulky apparatuses. Furthermore, each requires constant, wired attachment to a power supply and operators, which can limit visibility and impair the ability to move a patient without interference. Serial measurements require significant time, as several devices with separate leads are applied and removed to obtain measurements. Due to the varying and often large measurement heads of different devices, readings may not be obtained at exactly the same skin location, which impairs comparability of serial measurements. Additionally, the process of measurement can disturb the skin area being measured.

Asthma and anaphylaxis are common entities in children. During exacerbations, frequent monitoring of the vital parameters described is necessary to guide medical decision-making. Asthma exacerbations are associated with mild to severe symptoms that include cough, wheeze, tachypnea, retractions, labored breathing and respiratory fatigue. Food allergy reactions are potentially severe with life-threatening symptoms of anaphylactic shock that include, choking, respiratory distress and loss of consciousness. In the most severe cases reactions can be fatal or require emergency and intensive care treatment in the hospital. Convenient, easy to use, vital signs monitors are especially important in pediatric populations as children have less ability to self-monitor or describe their physical symptoms of life-threatening anaphylaxis or asthma exacerbation.

The wearable sensors offer a new, non-invasive and easy to use way to monitor vital signs of patients with asthma and anaphylaxis. Our previous experience testing our wearable vital sign sensors in multiple pediatric and neonatal studies since 2016, have shown a strong correlation to existing standard of care monitor data outputs. Additionally, the sensors have received positive feedback from patients and physicians, on their comfort, ease of use, and application.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advanced Multimodal Wireless Vital Signs Monitoring for Patients With Asthma and Anaphylaxis
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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 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
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.




Primary Outcome Measures :
  1. Percent agreement with pilot sensor and current standard [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Capture of patient feedback examining opinions on use of wearable sensors compared to standard of care devices.(Allergy patients) [ Time Frame: 2 years ]
    Use of Standardized survey instrument: IRB 2020-3403 Allergy Survey 2.21.20 Collects data on users perceived value of wireless monitoring, comfort, application and ease of use.

  2. Capture of patient feedback examining opinions on use of wearable sensors compared to standard of care devices.(Asthma patients) [ Time Frame: 2 years ]
    Use of Standardized survey instrument: IRB 2020-3403 Asthma Survey 2.21.20 Collects data on users perceived value of wireless monitoring, comfort, application and ease of use.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria

1. 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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360213


Contacts
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Contact: Knute Martell 312-503-5944 DermSensors@northwestern.edu

Sponsors and Collaborators
Northwestern University
Ann & Robert H Lurie Children's Hospital of Chicago
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Responsible Party: Shuai (Steve) Xu, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT04360213    
Other Study ID Numbers: 2020-3403
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Asthma
Anaphylaxis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases