Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609616
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Feasibility of Measuring Volume of Inspiration Via Noninvasive Motion Sensors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility Of Measuring Volume of Inspiration Via Non-Invasive Motion Sensors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None