Thoracoabdominal Asynchrony and Respiratory Distress

Mass General Brigham

Status: Enrolling

Conditions: Respiratory Insufficiency

Treatments: Diagnostic Test: Objectively monitoring thoracoabdominal asynchrony

Study type: Interventional

Funder types: Other

Identifiers

NCT04626154

2019P001411

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 28 days to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Respiratory insufficiency or distress

Active Comparator group

Description:

Patients demonstrating respiratory insufficiency or distress.

Treatment:

Diagnostic Test: Objectively monitoring thoracoabdominal asynchrony

No respiratory insufficiency or distress.

Sham Comparator group

Description:

Patients NOT demonstrating respiratory insufficiency or distress.

Treatment:

Diagnostic Test: Objectively monitoring thoracoabdominal asynchrony