Postoperative Pulmonary Complications (PPCs)NCT06609616
Feasibility of Measuring Volume of Inspiration Via Noninvasive Motion Sensors
A study testing Motion Sensor and Incentive Spirometer in people with Postoperative Pulmonary Complications (PPCs), run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Pulmonary Complications (PPCs)
- What is being tested?
- Motion Sensor and Incentive Spirometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 4 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Motion Sensor, Incentive Spirometer
- Keywords
- Measuring Volume of Inspiration, Motion Sensors, Wearable Incentive Spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion SensorDevice
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.
Incentive SpirometerDevice
A device that measures the volume of the air inhaled into the lungs during inspiration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Motion Sensor; Device: Incentive Spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15-20 minutes from start of the study
Secondary outcomes (1)
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.
Measured: Within a month of study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start21 Jan 2025
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative Pulmonary Complications (PPCs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter A Pinto, M.D., Principal investigator, National Institutes of Health, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609616
- Sponsor's protocol ID
- 10001915
- Other IDs
- 001915-CC
- Status last verified
- 14 Jan 2026
- First submitted
- 21 Sep 2024
- Last updated
- 2 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data sharing complies with the institution's data management and sharing (DMS) policy
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Of Measuring Volume of Inspiration Via Non-Invasive Motion Sensors
- ClinicalTrials.gov ID
- NCT06609616
- Acronym / sponsor ID
- 10001915
- Keywords
- Measuring Volume of Inspiration, Motion Sensors, Wearable Incentive Spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Posted 2 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Experimental | Device: Motion Sensor, Device: Incentive SpirometerHealthy 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motion SensorThe 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 | Healthy participants |
| Incentive SpirometerA device that measures the volume of the air inhaled into the lungs during inspiration. | Device | Healthy participants |
Primary outcome
Participants With Collectable Waveform Data
Time frame: 15-20 minutes from start of the study
Number of participants with collectable waveform data, which corresponds to each breathing exercise from the wearable motion sensor and uploaded to a secured database.
1 secondary outcome
Participants With Convertible Chest Wall Motion Waveform
Time frame: Within a month of study completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data sharing complies with the institution's data management and sharing (DMS) policy
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Physical Function Before Surgery and Lung Complications After Lung Surgery
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Enrolling by invitation
Evaluation of the Effectiveness of Lung-Protective Ventilation in Patients Undergoing Laparoscopic Gastrectomy
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Recruiting
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CABG, Respiratory Insufficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Pinto, M.D. principal investigator
National Institutes of Health, National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion Sensor and Incentive Spirometer in people with Postoperative Pulmonary Complications (PPCs), run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Collectable Waveform Data (time frame: 15-20 minutes from start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.