Feasibility of Measuring Volume of Inspiration Via Noninvasive Motion Sensors

Feasibility Of Measuring Volume of Inspiration Via Non-Invasive Motion Sensors

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 one 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 one 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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pulmonary Complications (PPCs)
• Intervention / Treatment: Device: Motion Sensor; Device: Incentive Spirometer

Detailed Description

Study Description:

This protocol is a basic physiologic proof-of-concept study enrolling normal volunteers to determine the feasibility of measuring volume of inspiration from chest wall motion measured via non-invasive thoracic motion sensors. The motion sensors are not medical devices because they are not intended to diagnose a disease or condition or to cure, mitigate, treat or prevent disease. Since motion sensors are not being evaluated for diagnostic purposes or being studied themselves within the context of this protocol and are only intended to collect physiological data, they are not to be considered investigational. The data collected in this feasibility study will not contain any personally identifiable information (PII). In this study, healthy participants will complete a total of approximately 18 measured breaths through a traditional incentive spirometer while wearing small, non-invasive motion sensors on their thorax at approximately the level of the 9th and 10th ribs unilaterally or bilaterally. The incentive spirometer is an FDA approved medical device. This study does not aim to study the safety or effectiveness of this device but rather utilize the device as a tool to measure volume of inspiration. The waveform data collected from the devices with each breath will then be analyzed with the intention to develop an algorithm that could convert chest wall motion to a discrete volume of inspiration in real time. Total enrollment time will be about 10-30 minutes per participant.

Objectives:

Primary: To collect chest wall motion data corresponding to various volumes of inspiration from a non-invasive wearable device.

Secondary: To develop an algorithm which can convert chest wall motion to volume of inspiration and assess the algorithm using cross-validation strategy.

Endpoints:

Primary: A database of motion waveforms corresponding to each measured volume of inspiration via traditional incentive spirometer.

Secondary: A cross-validated algorithm that converts chest wall motion to volume of inspiration.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• INCLUSION CRITERIA:

In order to be eligible to participate in this proof-of-concept study, an individual must meet all the following criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female sex, aged 18-100.
4. Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Pregnancy.
2. Known allergic reactions to adhesive.
3. Patients with an altered mental status that precludes understanding and consenting for the procedure and compliance with the study activities.
4. Patients with known pulmonary conditions including pulmonary fibrosis, asthma, chronic obstructive pulmonary disease (COPD), or chronic bronchitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy participants; Healthy participants completed a total of approximately 18 measured breaths through a traditional incentive spirometer while wearing small, non-invasive motion sensors taped to the right rib cage.	Device: Motion Sensor; The motion sensor is the 10-axis Bluetooth Gyro Inclinometer by Wit Motion and is marketed for rehabilitation exercises, workplace injury prevention, patient care, and healthy short-range wireless motion measurements.; Device: Incentive Spirometer; A device that measures the volume of the air inhaled into the lungs during inspiration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Collectable Waveform Data	Number of participants with collectable waveform data, which corresponds to each breathing exercise from the wearable motion sensor and uploaded to a secured database.	15-20 minutes from start of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Convertible Chest Wall Motion Waveform	Participants with waveform data that support the development and and validation of an algorithm that converts chest-wall motion waveforms into estimated volumes of inspiration. For each participant, motion waveforms is annotated with the corresponding measured inspiratory volumes.	Within a month of study completion

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: Peter A Pinto, M.D., National Institutes of Health, National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): April 4, 2025

Study Registration Dates

• First Submitted: September 21, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 14, 2026

More Information

Terms related to this study

• Keywords: Measuring Volume of Inspiration; Motion Sensors; Wearable Incentive Spirometry
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 10001915; 001915-CC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing complies with the institution's data management and sharing (DMS) policy
• IPD Sharing Time Frame: From study completion

IPD Sharing Access Criteria

This study complies with the National Institutes of Health (NIH) public access policy, which ensures that the public has access to the published results of NIH funded research.

Data can also be provided to investigators for future study upon written request.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes