Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children

NCT ID: NCT04873193

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-01-21

Brief Summary

This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condition (such as asthma).

There is no product currently on the market that is comparable to this novel Leo device

The study consists of a single visit to evaluate the feasibility and safety of using the Leo device on 20 children with clinically stable asthma.

Stable asthmatic children between the age of 3 and 6, inclusive, will be recruited.

There will be no disease-specific intervention, nor changes to the participant's care management program for their asthma.

Conditions

Asthma in Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Oscillometry + Pneumotach Procedure with Leo Device measurements

All patients will undergo oscillometry procedure, followed by pneumotach procedure to measure tidal volume in different sitting positions. The Leo device will be worn throughout both procedures to measure the chest electrical impedance and compare against pneumotach measurements.

Oscillometry and pneumotach are part of standard of care.

Group Type: OTHER

Leo device

Intervention Type: DEVICE

Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures.

Interventions

Leo device

Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures.

Intervention Type: DEVICE

Other Intervention Names

Pneumotachometer (BioPaC systems, Inc., Goleta, CA, USA) connected to anti-bacterial filter and mouth piece.

Eligibility Criteria

Inclusion Criteria

• Children aged ≥3 years old and ≤18 years old at time of consent
• Children with a legal guardian able to sign consent for study participation
• Children and caregivers able to read and understand English or Spanish
• Investigator confirmation for diagnosis of clinically stable respiratory condition, such as clinically diagnosed asthma
• Children who are able to follow instructions and complete oscillometry and tidal breathing tasks

Exclusion Criteria

• - Children <3 and >18 years of age
• Adults (age ≥ 18 years)
• Children with complex medical conditions which may hinder their ability to complete protocol assessments
• Children who do not have a legal guardian to sign informed consent form
• Children with an active skin condition involving the area on the chest wall where the Leo device will be attached. E.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment
• Child is determined not eligible by the assessment of the PI
• Fever within the 4 weeks prior to enrollment
• Children with any implanted medical devices, E.g. cardiac pacemaker
• Children with any history of known allergic reaction to adhesives or hydrogels, as the ones used with the Leo device
• Children who have taken a bronchodilator in the last 8-24 hours prior to study visit, depending on the type of medication.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Liu

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

Children's Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Other Identifiers

OTH-21-02-01

Identifier Type: -

Identifier Source: org_study_id