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NCT04626154 Clinical Trial

Thoracoabdominal Asynchrony and Respiratory Distress

Respiratory Insufficiency Clinical Trial

Official title:
Validation of a Non-Invasive Device for Thoracoabdominal Asynchrony-Based Respiratory Effort Assessment in Pediatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04626154
Other study ID # 2019P001411
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 16, 2020
Est. completion date June 1, 2024

Study information
Verified date August 2022
Source Massachusetts General Hospital
Contact Ryan Carroll, MD, MPH
Phone 7733328178
Email rcarroll4@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators hypothesize that a simple 3-point tracking device that uses motion sensors attached to the abdomen and chest of a child will provide information regarding thoracoabdominal asynchrony (TAA), a major component of respiratory distress, and ultimately help guide a clinician to initiate, escalate, de-escalate, or stop respiratory support interventions. AIMS To determine if the TAA-monitoring device can be used to detect differences in respiratory synchrony in a manner that is clinically applicable. The investigators hope that the device will detect 1) major asynchrony events in a timely manner so as to prompt clinician intervention during future use; and 2) asynchrony events that may be less visible to the naked eye that may be precursors to more severe events.

Description:

Respiratory diseases are a major global cause of morbidity and mortality in children. Of patients admitted into a pediatric intensive care unit (PICU), respiratory illnesses have been identified as the leading principal admission diagnosis in every age group, accounting for 37.9% of patients under 12 months of age and 28.5% of PICU patients across all age groups. Continuous monitoring of respiratory status is important for the guidance of respiratory support escalation and de-escalation decisions in the PICU. A clinical metric that has been suggested as a signature of breathing effort is thoracoabdominal asynchrony (TAA), the non-coincident motion of the rib cage and abdomen during breathing. A reliable, objective assessment tool for continuous monitoring of respiratory effort could allow for a more complete understanding of patients' real-time respiratory status and provide an additional indication or contraindication for the utilization of various levels of respiratory support. Limiting the use of invasive ventilatory support by early detection of respiratory distress would decrease clinical risk to patients and has the potential to decrease the cost of patient stays in the PICU. The investigators have developed a non-invasive TAA-sensing device designed for use by clinicians to indirectly quantify respiratory effort among pediatric patients (henceforth referred to as the "TAA-monitoring device"). The device utilizes motion-tracking sensors that capture data that is then processed to provide a quantitative indication of a patient's respiratory status. Given the promising yet inconclusive nature of the evidence supporting the use of TAA as an indicator of respiratory effort, clinical validation of this device is a necessary step to take to support its continued development.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 28 Days to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Objectively monitoring thoracoabdominal asynchrony
Objectively monitoring thoracoabdominal asynchrony

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objectively determine thoracoabdominal asynchrony The investigators aim to objectively measure the frequency of asynchrony over time (minutes). Over 30 - 7200 minutes
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