Thoracoabdominal Asynchrony and Respiratory Distress

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04626154
Status
Recruiting

Conditions

  • Respiratory Insufficiency

Eligibility Criteria

Sex
ALL
Age
28 Days - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Objectively monitoring thoracoabdominal asynchrony — DIAGNOSTIC_TEST
    Objectively monitoring thoracoabdominal asynchrony

Study Details

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.

Key Dates

Start date
Oct 16, 2020
Status verified
Apr 2026
Primary completion
Apr 30, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Ryan Carroll, MD, MPH
617-724-4380
Ryan Carroll, MD, MPH (PRINCIPAL_INVESTIGATOR)

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