20 Participants NeededMy employer runs this trial

3-Point Tracking Device for Respiratory Insufficiency

RC
Overseen ByRyan Carroll, MD, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to track breathing patterns in children, aiding doctors in managing breathing support. Sensors placed on the chest and abdomen detect subtle breathing problems. The goal is to determine if this device can predict and prevent serious respiratory issues by objectively monitoring thoracoabdominal asynchrony. Children with or without noticeable breathing trouble may qualify, provided they can wear the sensors.

As an unphased trial, participation offers a chance to contribute to innovative research that could enhance respiratory care for children.

What prior data suggests that this 3-point tracking device is safe for children?

Research has shown that using a device to monitor chest and belly movements during breathing is generally safe. In studies involving patients with conditions like COPD, this monitoring was well-tolerated. The device employs motion sensors to track breathing movements, aiding doctors in understanding breathing issues without causing harm.

No major reports of problems have emerged from using this type of monitoring device. Designed to be non-invasive, it does not enter the body, which typically results in fewer side effects. Similar devices have been used in medical settings without major safety concerns. Participants can feel reassured about the safety of this method while contributing to improved treatment for breathing problems.12345

Why are researchers excited about this trial?

Researchers are excited about the 3-Point Tracking Device for Respiratory Insufficiency because it offers a new way to objectively monitor thoracoabdominal asynchrony, a sign of respiratory distress. Unlike standard treatments, which primarily rely on subjective observation and patient self-reporting, this device provides precise, real-time data on how the chest and abdomen move during breathing. This could lead to earlier detection and more accurate assessments of respiratory issues, potentially improving patient outcomes by allowing for timely interventions.

What evidence suggests that this 3-point tracking device is effective for respiratory insufficiency?

This trial will evaluate a device for objectively monitoring thoracoabdominal asynchrony (TAA) in patients with respiratory insufficiency or distress. Research has shown that monitoring TAA, where the chest and abdomen do not move in sync, can aid in managing breathing problems. Studies have found that measuring TAA can detect respiratory issues in children before they become obvious. Specifically, one study discovered that using sensors to track TAA provided reliable information to guide medical decisions. Another study noted that TAA measurement is a promising method for evaluating breathing problems in various conditions, such as asthma. Therefore, using a device to monitor TAA might help identify early signs of breathing trouble.12678

Who Is on the Research Team?

RC

Ryan Carroll, MD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for children and teenagers from 28 days to 17 years old, both with and without respiratory distress. It's not suitable for those who have injuries or conditions that would interfere with attaching a motion-sensing device to their chest and abdomen.

Inclusion Criteria

I am between 28 days and 17 years old and have trouble breathing.
I am between 28 days and 17 years old and do not have trouble breathing.

Exclusion Criteria

I don't have any injuries or conditions that would prevent using a specific medical device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Validation

Participants are monitored using the TAA-monitoring device to assess thoracoabdominal asynchrony

30 minutes to 5 days
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after device use

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Objectively monitoring thoracoabdominal asynchrony

Trial Overview

The study is testing a new device designed to monitor thoracoabdominal asynchrony (TAA) - when the chest and belly don't move in sync during breathing, which can indicate respiratory distress. The goal is to see if this device can help clinicians make decisions about providing or adjusting respiratory support.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Respiratory insufficiency or distressActive Control1 Intervention
Group II: No respiratory insufficiency or distress.Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Citations

Usefulness of Thoraco-Abdominal Synchrony Assessment in ...

This study evaluated thoracoabdominal asynchrony (TAA) in patients COPD exacerbation during the first four days of hospitalization, focusing on ...

Thoracoabdominal Asynchrony and Respiratory Distress

A reliable, objective assessment tool for continuous monitoring of respiratory ... The device utilizes motion-tracking sensors that capture data ...

The Measurement of Thoraco-abdominal Asynchrony in ...

Methods to objectively assess severity of respiratory distress in children. Clinical trials have adopted a variety of clinical scores as outcome measures, but ...

Measurements of Thoraco-Abdominal Asynchrony and ...

Thoraco-Abdominal Asynchrony Continuous phase angle measurement is a promising non-invasive technique for the objective assessment of TAA in a variety of ...

Automated Assessment of Thoracic-Abdominal Asynchrony in ...

Thoracic-abdominal asynchrony measured using RIP has been identified as a clin- ical diagnostic for many pulmonary diseases such as asthma [10], ...

Machine learning for automatic identification of ... - PMC

Thoracoabdominal asynchrony has been identified as a clinical diagnostic indicator for many pulmonary diseases such as asthma, chronic obstructive pulmonary ...

Large Observational Study to UNderstand the Global ...

The purpose of this study is to provide new and current data on the disease burden of acute hypoxemic respiratory failure and ARDS.

(PDF) Contactless Monitoring of Breathing Pattern and ...

This study aims to develop a contactless method to monitor breathing patterns and thoracoabdominal asynchronies in infants inside the incubator, ...