Thoracoabdominal Asynchrony and Respiratory Distress

NCT04626154 | Recruiting

• 1 other identifier: 2019P001411
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• Objectively determine thoracoabdominal asynchrony

  The investigators aim to objectively measure the frequency of asynchrony over time (minutes).

  Over 30 - 7200 minutes

Study Arms (2)

Respiratory insufficiency or distress

ACTIVE COMPARATOR

Patients demonstrating respiratory insufficiency or distress.

Diagnostic Test: Objectively monitoring thoracoabdominal asynchrony

No respiratory insufficiency or distress.

SHAM COMPARATOR

Patients NOT demonstrating respiratory insufficiency or distress.

Diagnostic Test: Objectively monitoring thoracoabdominal asynchrony

Interventions

Objectively monitoring thoracoabdominal asynchrony DIAGNOSTIC_TEST

Objectively monitoring thoracoabdominal asynchrony

No respiratory insufficiency or distress.; Respiratory insufficiency or distress

Eligibility Criteria

• Age: 28 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients 28-days to 17-years of age
• who have respiratory distress and those who do not have respiratory distress

You may not qualify if:

• Hardware, clinical care, or dermal injury that would preclude the application of TAA device

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ryan Carroll, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Carroll, MD, MPH

CONTACT

7733328178; rcarroll4@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff physician

Model Details: We aim to enroll pediatric patients admitted to the MGH Pediatric Intensive Care Unit (PICU): 10 patients with respiratory distress and 10 patients without respiratory distress. Readings from the TAA-monitoring device will be compared to clinical assessments made by nurses and physicians.

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: November 12, 2020
• Study Start: October 16, 2020
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)