Thoracoabdominal Asynchrony and Respiratory Distress

NCT ID: NCT04626154

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2024-06-01

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.

Conditions

Respiratory Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Respiratory insufficiency or distress

Patients demonstrating respiratory insufficiency or distress.

Group Type: ACTIVE_COMPARATOR

Objectively monitoring thoracoabdominal asynchrony

Intervention Type: DIAGNOSTIC_TEST

Objectively monitoring thoracoabdominal asynchrony

No respiratory insufficiency or distress.

Patients NOT demonstrating respiratory insufficiency or distress.

Group Type: SHAM_COMPARATOR

Objectively monitoring thoracoabdominal asynchrony

Intervention Type: DIAGNOSTIC_TEST

Objectively monitoring thoracoabdominal asynchrony

Interventions

Objectively monitoring thoracoabdominal asynchrony

Objectively monitoring thoracoabdominal asynchrony

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ryan Carroll

Staff physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Carroll, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ryan Carroll, MD, MPH

Role: CONTACT

rcarroll4@mgh.harvard.edu

7733328178

Facility Contacts

Ryan Carroll, MD, MPH

Role: primary

rcarroll4@mgh.harvard.edu

617-724-4380

Other Identifiers

2019P001411

Identifier Type: -

Identifier Source: org_study_id