Motion Sensors for Monitoring Breathing

Overseen By Charisse Garcia, R.N.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Institutes of Health Clinical Center (CC)

Disqualifiers: Pregnancy, Allergic to adhesive, Pulmonary conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Lung problems develop in up to 20% of people after they have surgery. While under general anesthesia, people breathe slower and draw in less air. They may have difficulty returning to normal deep breathing as they recover. Some may develop life-threatening complications. An approved device called an incentive spirometer is used to help measure and improve a person s breathing after surgery. Researchers want to find out if a motion sensor placed on the chest can also measure the volume of air a person inhales as they breathe. Objective: To determine if a motion sensor on the chest can measure the volume of air a person breathes. Eligibility: Healthy adults aged 18 years and older. Design: Participants will have 1 clinic visit. The visit will last 10 to 30 minutes. They will fill out a form with their age, sex, height, and weight. A small, plastic motion sensor will be taped to their chest on 1 or both sides. Participants will breathe through a tube attached to an incentive spirometer. They will take 18 breaths of different volumes, both deep and shallow. Researchers will use the data collected from the motion sensors to measure how the chest moves at different levels of breathing. The motion sensor data will be used to create a software program that converts chest wall motion to the volume of air inhaled for a given breath in real time.

Research Team

Bradford J Wood, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Eligibility Criteria

This clinical trial is for healthy adults aged 18 and older. It's designed to test if a motion sensor can accurately measure how much air they breathe in after surgery, which could help prevent lung problems like pneumonia.

Inclusion Criteria

I can understand and am willing to sign the consent form.

I am willing and able to follow the study rules and attend all required visits.

Provision of signed and dated informed consent form

Exclusion Criteria

Pregnancy

Known allergic reactions to adhesive

I am able to understand and consent to the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Data Collection

Participants will have a clinic visit where they will fill out a form and have a motion sensor taped to their chest to measure breathing volumes.

10-30 minutes

1 visit (in-person)

Algorithm Development

Data collected will be used to develop an algorithm to convert chest wall motion to volume of inspiration.

3 months

Follow-up

Participants are monitored for any immediate reactions or issues post data collection.

1 day

Treatment Details

Interventions

• Noninvasive Motion Sensors

Trial Overview Researchers are testing a noninvasive motion sensor taped to the chest against an approved device called an incentive spirometer that measures breathing volume. Participants will take breaths of varying depths while data is collected.

Participant Groups

Group I: Healthy Volunteers Experimental Treatment 2 Interventions

Healthy volunteers of all genders and demographic groups who are ages 18 and older.

Who Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials

391

Recruited

30,880,000+