Recruiting

TAA Monitoring

Sponsor:

Massachusetts General Hospital

Code:

NCT04626154

Conditions

Respiratory Insufficiency

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Objectively monitoring thoracoabdominal asynchrony

Study Details

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

Study ID

NCT04626154

Start date

Oct 16, 2020

Status verified date

Jul, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

active comparator: Respiratory insufficiency or distress

Patients demonstrating respiratory insufficiency or distress.

sham comparator: No respiratory insufficiency or distress.

Patients NOT demonstrating respiratory insufficiency or distress.

Interventions

Objectively monitoring thoracoabdominal asynchrony

Objectively monitoring thoracoabdominal asynchrony

Primary outcome measure

  • Objectively determine thoracoabdominal asynchrony [ Time Frame: Over 30 - 7200 minutes ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Ryan Carroll, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-13.