Clinical trial NCT04626154: Thoracoabdominal Asynchrony and Respiratory Distress
Official title: Validation of a Non-Invasive Device for Thoracoabdominal Asynchrony-Based Respiratory Effort Assessment in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 20
Sex: ALL
Minimum age (years): 28
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DEVICE_FEASIBILITY

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objectively determine thoracoabdominal asynchrony
timeFrame: Over 30 - 7200 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan Carroll, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: