Thoracoabdominal Asynchrony and Respiratory Distress
Primary Purpose
Respiratory Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Objectively monitoring thoracoabdominal asynchrony
Sponsored by
About this trial
This is an interventional device feasibility trial for Respiratory Insufficiency
Eligibility Criteria
Inclusion Criteria:
- patients 28-days to 17-years of age
- 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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Respiratory insufficiency or distress
No respiratory insufficiency or distress.
Arm Description
Patients demonstrating respiratory insufficiency or distress.
Patients NOT demonstrating respiratory insufficiency or distress.
Outcomes
Primary Outcome Measures
Objectively determine thoracoabdominal asynchrony
The investigators aim to objectively measure the frequency of asynchrony over time (minutes).
Secondary Outcome Measures
Full Information
NCT ID
NCT04626154
First Posted
October 16, 2020
Last Updated
August 8, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04626154
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Respiratory insufficiency or distress
Arm Type
Active Comparator
Arm Description
Patients demonstrating respiratory insufficiency or distress.
Arm Title
No respiratory insufficiency or distress.
Arm Type
Sham Comparator
Arm Description
Patients NOT demonstrating respiratory insufficiency or distress.
Intervention Type
Diagnostic Test
Intervention Name(s)
Objectively monitoring thoracoabdominal asynchrony
Intervention Description
Objectively monitoring thoracoabdominal asynchrony
Primary Outcome Measure Information:
Title
Objectively determine thoracoabdominal asynchrony
Description
The investigators aim to objectively measure the frequency of asynchrony over time (minutes).
Time Frame
Over 30 - 7200 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients 28-days to 17-years of age
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Carroll, MD, MPH
Phone
7733328178
Email
rcarroll4@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Carroll, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Carroll, MD, MPH
Phone
617-724-4380
Email
rcarroll4@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Ryan Carroll, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
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Thoracoabdominal Asynchrony and Respiratory Distress
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