Feasibility of Measuring Volume of Inspiration Via Noninvasive Motion Sensors

NCT06609616 | Completed Results FDA Device

• 2 other identifiers: 10001915001915-CC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pulmonary Complications (PPCs)

Keywords

Measuring Volume of Inspiration; Motion Sensors; Wearable Incentive Spirometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participants With Convertible Chest Wall Motion Waveform

  Within a month of study completion

Study Arms (1)

Healthy participants

EXPERIMENTAL

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; Device: Incentive Spirometer

Interventions

Motion Sensor DEVICE

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.

Healthy participants

Incentive Spirometer DEVICE

A device that measures the volume of the air inhaled into the lungs during inspiration.

Healthy participants

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this proof-of-concept study, an individual must meet all the following criteria:
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female sex, aged 18-100.
• Ability of subject to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Pregnancy.
• Known allergic reactions to adhesive.
• Patients with an altered mental status that precludes understanding and consenting for the procedure and compliance with the study activities.
• Patients with known pulmonary conditions including pulmonary fibrosis, asthma, chronic obstructive pulmonary disease (COPD), or chronic bronchitis.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Results Point of Contact

• Title: Dr. Peter Pinto
• Organization: National Cancer Institute (NCI)

pintop@mail.nih.gov

240-858-3700

Study Officials

• Peter A Pinto, M.D.

  National Institutes of Health, National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 24, 2024
• Study Start: January 21, 2025
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01-14

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From study completion
• 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.

Locations

US (1)