N/A
N=30
Feasibility of Measuring Volume of Inspiration Via Noninvasive Motion Sensors
Postoperative Pulmonary Complications (PPCs)
Bottom Line
View on ClinicalTrials.gov: NCT06609616 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Participants With Collectable Waveform Data — 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motion Sensor (Device); Incentive Spirometer (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institutes of Health Clinical Center (CC)
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Collectable Waveform Data |
30 | — |
| SECONDARY Participants With Convertible Chest Wall Motion Waveform |
30 | — |
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.
Eligibility Criteria
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA
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.
Data sourced from ClinicalTrials.gov (NCT06609616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.