Tracking chest and abdominal motion to detect breathing mismatch in children
Validation of a Non-Invasive Device for Thoracoabdominal Asynchrony-Based Respiratory Effort Assessment in Pediatric Patients
This project will test whether small motion sensors placed on a child's chest and belly can detect mismatched breathing (thoracoabdominal asynchrony) to help guide when to start, change, or stop breathing support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 28 Days to 17 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04626154 on ClinicalTrials.gov |
What this trial studies
Investigators will use a non-invasive wearable device with motion-tracking sensors attached to the chest and abdomen to continuously record thoracoabdominal motion in children. The device will be applied to patients aged 28 days to 17 years with and without respiratory distress to compare synchrony patterns. The goal is to determine whether the device reliably detects major asynchrony events and subtler precursors that are not obvious to the naked eye. Data collection occurs at Massachusetts General Hospital and is intended to inform clinician decisions about escalating or de-escalating respiratory support.
Who should consider this trial
Good fit: Children aged 28 days to 17 years who have or are at risk of respiratory distress and can safely wear sensors on their chest and abdomen are the ideal candidates.
Not a fit: Children with skin injury, implanted or external hardware that prevents sensor placement, or respiratory problems unrelated to thoracoabdominal asynchrony may not receive benefit from this device.
Why it matters
Potential benefit: If successful, this device could give clinicians early, objective warnings of worsening breathing so they can adjust support sooner, potentially reducing invasive ventilation and shortening PICU stays.
How similar studies have performed: Prior research shows thoracoabdominal asynchrony is a useful marker of respiratory effort, but using simple wearable motion sensors for continuous bedside detection in pediatric patients is a relatively new approach with limited outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients 28-days to 17-years of age 2. who have respiratory distress and those who do not have respiratory distress Exclusion Criteria: Hardware, clinical care, or dermal injury that would preclude the application of TAA device
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Ryan Carroll, MD, MPH — Massachusetts General Hospital
- Study coordinator: Ryan Carroll, MD, MPH
- Email: rcarroll4@mgh.harvard.edu
- Phone: 7733328178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.