Clinical trial NCT06609616: Feasibility of Measuring Volume of Inspiration Via Noninvasive Motion Sensors
Official title: Feasibility Of Measuring Volume of Inspiration Via Non-Invasive Motion Sensors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pulmonary Complications (PPCs)
Keywords: Measuring Volume of Inspiration
Motion Sensors
Wearable Incentive Spirometry
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2024-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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 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.

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.

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:

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, COPD, or chronic bronchitis.

Primary outcomes:
measure: Chest Wall Motion Data
timeFrame: Day 1
Secondary outcomes:
measure: Algorithm
timeFrame: 3 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Bradford J Wood, M.D.
role: PRINCIPAL_INVESTIGATOR
References: