COPDNCT04182711
Feasibility Study of a Non-invasive Device to Quickly, Easily and Accurately Measure Respiration in a Clinical Setting
A study testing Device in people with COPD, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Healthcare facilities worldwide still measure respiration manually by counting and timing chest movements. In clinical departments that are fast-paced in nature and that have either high patient volumes or require more accurate measurements (e.g. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- COPD
- What is being tested?
- Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Dec 2017to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with cardio-respiratory diseases of either asthma, COPD, pneumonia, congestive heart failure or any other respiratory diseases.
- Patients should be able to provide informed consent either personally or through the next-of-kin. The study will consider a mix of mild to severe cases and will not be specific to either gender, sex or ethnicity.
- Patients with congestive heart failure only from general ward or cardiology high dependency units.
Who cannot join
- Patients that are either mentally incompetent, younger than 21 years of age, prisoners, pregnant or breastfeeding women.
- Patients with metallic/electrical implants e.g. pacemakers, cardiac devices, airway stents, neurostimulators etc.
- Patients with coronary stents insitu are eligible for enrolment into the study. Any medical condition which makes the candidate an inappropriate subject for study participation, in the investigator's judgment will further be excluded.
- Congestive heart failure patients on antibiotics or with infection.
- Congestive heart failure patients beyond 72 hours of presentation from enrolment. Intent is to capture congestive heart failure at the acute stage, prior to resolving.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Clinical Trials & Research Unit
Singapore, 529889
Carolyn Yap, 68502379, carolyn.yap.s.y@singhealth.com.sg
About this study
Healthcare facilities worldwide still measure respiration manually by counting and timing chest movements. In clinical departments that are fast-paced in nature and that have either high patient volumes or require more accurate measurements (e.g. emergency and respiratory wards), manual methods of counting respiration can be slow, laborious and highly subjective. While potential solutions such as electrocardiography (ECG) and capnography (CPG) have been explored for more objective monitoring of respiration, they are not fast enough due to long setup times to get patient and system ready and prolonged periods of connection to patients. Furthermore, such ECG/CPG based solutions can be costly, are generally sufficient for patients in high dependency units, and may be impractical to deploy in a remote setting.
Read the detailed description
The study will be divided into 2 phases - 1st phase will last 1.5 months and will aim to recruit at least 50 patients and at most 100 patients. This phase will aim to recruit near-equal split of patients across the 3 disease states of COPD, asthma and pneumonia - 35 COPD, 35 Asthma and 30 pneumonia patients. The 2nd phase will last 3 months and will aim to recruit at least 50 patients. This phase can have a mix of patients having either COPD, asthma, pneumonia, congestive heart failure or any other respiratory diseases
The aim in the 1st phase is to benchmark the device against manual counting of respiration (number of breaths per minute). The aim in the 2nd phase is to benchmark the device against existing technologies, namely lead-based-ECG sensing, acoustic sensing and capnography. This phase can have a mix of patients having either COPD, asthma, pneumonia or any other respiratory diseases
Following is the study protocol that will be implemented over the 2 phases:
Phase 1: 1.5 months - 100 patients - General Wards (Time taken for each patient is 25 mins)
- Delegated study team members will brief the study details to the potential participants. Investigators will answer the query from potential participants if any, and complete the consent process. (5 mins) b. Trial coordinator will setup the device as follows: (10 mins) i. Disinfect the device by wiping with an alcohol swab, ii. Turn on the sensor - ensure the USB dongle is connected to the RIGHT ports on the laptop - check that the USB dongle AND the sensor light is NOT blinking iii. Paste the sensor on patient using a medical-grade adhesive tape.
- Trial coordinator will begin data collection by double click the software .exe file - select the COM ports and enter participant no. (a folder will be created in root directory for the participant number) d. Click "run" button on the software and start to manually count the number of breaths after 1 minute. After 1 minute, the number of breaths counted manually will be recorded on the case report form.4 rounds of 1-minute measurements will be taken e. Trial coordinator will turn off the device and pass it back to team-member or keep it. Trial coordinator will remove the medical-grade adhesive tape and throw it away. (5 mins) f. Team-member will post-process the collected respiration data, benchmark against the manually counted data in the data collection form provided by trial coordinator and discuss the results with investigating P.Is.
Phase 2: 3 months - 50 patients - Medical intensive care units (MICU), medical dependency units (MDU), cardiology high dependency units, and general wards (for congestive heart failure patients) (Time taken for each patient is 30 mins) g. Delegated study team members will brief the study details to the potential participants. Investigators will answer the query from potential participants if any, and complete the consent process. In the event that the patient is unable to provide consent, the next-of-kin will be approached for consent. (5 mins) h. Trial coordinator will setup the device as follows: (10 mins) i. Disinfect the device by wiping with an alcohol swab, ii. Turn on the sensor - ensure the USB dongle is connected to the RIGHT ports on the laptop - check that the USB dongle AND the sensor light is NOT blinking iii. Paste the sensor on patient using a medical-grade adhesive tape. iv. Attach another sensor on the patient's finger using an adapter. The purpose of this is to collect heart rate and Sp02, and to calculate respiration from the collected data.
- Trial coordinator will begin data collection by double click the software .exe file - select the COM ports and enter participant no. (a folder will be created in root directory for the participant number) j. Click "run" button on the software. After 1 minute, the number of breaths, heart rate and Sp02 from other technology devices will be recorded on the case report form.4 rounds of 1-minute measurements will be taken.
- Trial coordinator will turn off the device and pass it back to team-member or keep it. Trial coordinator will remove the medical-grade adhesive tape and throw it away. (5 mins). Trial coordinator will also remove the device and adapter from the finger location.
- Team-member will post-process the collected respiration data, benchmark it and discuss the results with investigating P.Is.
All data collected will be anonymous and no video-taping will be done. The trial coordinator will act as the control arm. They will measure the respiration or breathing rate of the subject manually - by counting the number of breaths per minute. The non-control arm will be the device itself and it will be benchmarked to the manual respiration data collected by the trial coordinator. The data collected will be kept with the P.I and confidentially of the data will strictly be maintained. The case report forms or the collection forms will be passed to the P.I. and kept safely. The subject may choose to withdraw from the study at any time.
The device is based on multi-modal sensing using illumination at extremely low emission levels on the order of microwatts. This sensing technique is able to detect the micro-vibrations along the neck due to breathing.
- Conditions
- COPD
- Being tested
- Device
- Keywords
- COPD, Asthma, Pneumonia, Congestive heart failure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Pneumonia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeviceDevice
Phase 1: Time taken for each patient is 25 mins Phase 2: Time taken for each patient is 30 mins
| Study group | Role | What they receive |
|---|---|---|
| Device Arm | Experimental | The aim in the 1st phase is to benchmark the device against manual counting of respiration (number of breaths per minute). The aim in the 2nd phase is to benchmark the device against existing technologies, namely lead-based-ECG sensing, acoustic sensing and capnography. This phase can have a mix of patients having either COPD, asthma, pneumonia or any other respiratory diseases Receives: Device: Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of this device on disease subjects in a clinical setting.
The device will be compared against "gold-standard" manual counting and against existing technologies such as lead-based ECG, capnography and acoustic-based sensing.
Measured: 4.5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 Dec 2017
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Responsible party
- Sponsor
- Investigators
- Dr Augustine Tee, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182711
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2020
- First submitted
- 27 Nov 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Non-invasive Device to Quickly, Easily and Accurately Measure Respiration in a Clinical Setting
- ClinicalTrials.gov ID
- NCT04182711
- Acronym / sponsor ID
- 1
- Conditions
- COPD
- Keywords
- COPD, Asthma, Pneumonia, Congestive heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthcare facilities worldwide still measure respiration manually by counting and timing chest movements. In clinical departments that are fast-paced in nature and that have either high patient volumes or require more accurate measurements (e.g. emergency and respiratory wards), manual methods of counting respiration can be slow, laborious and highly subjective. While potential solutions such as electrocardiography (ECG) and capnography (CPG) have been explored for more objective monitoring of respiration, they are not fast enough due to long setup times to get patient and system ready and prolonged periods of connection to patients. Furthermore, such ECG/CPG based solutions can be costly, are generally sufficient for patients in high dependency units, and may be impractical to deploy in a remote setting.
Detailed description
The study will be divided into 2 phases - 1st phase will last 1.5 months and will aim to recruit at least 50 patients and at most 100 patients. This phase will aim to recruit near-equal split of patients across the 3 disease states of COPD, asthma and pneumonia - 35 COPD, 35 Asthma and 30 pneumonia patients. The 2nd phase will last 3 months and will aim to recruit at least 50 patients. This phase can have a mix of patients having either COPD, asthma, pneumonia, congestive heart failure or any other respiratory diseases
The aim in the 1st phase is to benchmark the device against manual counting of respiration (number of breaths per minute). The aim in the 2nd phase is to benchmark the device against existing technologies, namely lead-based-ECG sensing, acoustic sensing and capnography. This phase can have a mix of patients having either COPD, asthma, pneumonia or any other respiratory diseases
Following is the study protocol that will be implemented over the 2 phases:
Phase 1: 1.5 months - 100 patients - General Wards (Time taken for each patient is 25 mins)
- Delegated study team members will brief the study details to the potential participants. Investigators will answer the query from potential participants if any, and complete the consent process. (5 mins) b. Trial coordinator will setup the device as follows: (10 mins) i. Disinfect the device by wiping with an alcohol swab, ii. Turn on the sensor - ensure the USB dongle is connected to the RIGHT ports on the laptop - check that the USB dongle AND the sensor light is NOT blinking iii. Paste the sensor on patient using a medical-grade adhesive tape.
- Trial coordinator will begin data collection by double click the software .exe file - select the COM ports and enter participant no. (a folder will be created in root directory for the participant number) d. Click "run" button on the software and start to manually count the number of breaths after 1 minute. After 1 minute, the number of breaths counted manually will be recorded on the case report form.4 rounds of 1-minute measurements will be taken e. Trial coordinator will turn off the device and pass it back to team-member or keep it. Trial coordinator will remove the medical-grade adhesive tape and throw it away. (5 mins) f. Team-member will post-process the collected respiration data, benchmark against the manually counted data in the data collection form provided by trial coordinator and discuss the results with investigating P.Is.
Phase 2: 3 months - 50 patients - Medical intensive care units (MICU), medical dependency units (MDU), cardiology high dependency units, and general wards (for congestive heart failure patients) (Time taken for each patient is 30 mins) g. Delegated study team members will brief the study details to the potential participants. Investigators will answer the query from potential participants if any, and complete the consent process. In the event that the patient is unable to provide consent, the next-of-kin will be approached for consent. (5 mins) h. Trial coordinator will setup the device as follows: (10 mins) i. Disinfect the device by wiping with an alcohol swab, ii. Turn on the sensor - ensure the USB dongle is connected to the RIGHT ports on the laptop - check that the USB dongle AND the sensor light is NOT blinking iii. Paste the sensor on patient using a medical-grade adhesive tape. iv. Attach another sensor on the patient's finger using an adapter. The purpose of this is to collect heart rate and Sp02, and to calculate respiration from the collected data.
- Trial coordinator will begin data collection by double click the software .exe file - select the COM ports and enter participant no. (a folder will be created in root directory for the participant number) j. Click "run" button on the software. After 1 minute, the number of breaths, heart rate and Sp02 from other technology devices will be recorded on the case report form.4 rounds of 1-minute measurements will be taken.
- Trial coordinator will turn off the device and pass it back to team-member or keep it. Trial coordinator will remove the medical-grade adhesive tape and throw it away. (5 mins). Trial coordinator will also remove the device and adapter from the finger location.
- Team-member will post-process the collected respiration data, benchmark it and discuss the results with investigating P.Is.
All data collected will be anonymous and no video-taping will be done. The trial coordinator will act as the control arm. They will measure the respiration or breathing rate of the subject manually - by counting the number of breaths per minute. The non-control arm will be the device itself and it will be benchmarked to the manual respiration data collected by the trial coordinator. The data collected will be kept with the P.I and confidentially of the data will strictly be maintained. The case report forms or the collection forms will be passed to the P.I. and kept safely. The subject may choose to withdraw from the study at any time.
The device is based on multi-modal sensing using illumination at extremely low emission levels on the order of microwatts. This sensing technique is able to detect the micro-vibrations along the neck due to breathing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Arm | Experimental | Device: DeviceThe aim in the 1st phase is to benchmark the device against manual counting of respiration (number of breaths per minute). The aim in the 2nd phase is to benchmark the device against existing technologies, namely lead-based-ECG sensing, acoustic sensing and capnography. This phase can have a mix of patients having either COPD, asthma, pneumonia or any other respiratory diseases |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with cardio-respiratory diseases of either asthma, COPD, pneumonia, congestive heart failure or any other respiratory diseases.
- Patients should be able to provide informed consent either personally or through the next-of-kin. The study will consider a mix of mild to severe cases and will not be specific to either gender, sex or ethnicity.
- Patients with congestive heart failure only from general ward or cardiology high dependency units.
Key exclusion criteria (5 listed)
- Patients that are either mentally incompetent, younger than 21 years of age, prisoners, pregnant or breastfeeding women.
- Patients with metallic/electrical implants e.g. pacemakers, cardiac devices, airway stents, neurostimulators etc.
- Patients with coronary stents insitu are eligible for enrolment into the study. Any medical condition which makes the candidate an inappropriate subject for study participation, in the investigator's judgment will further be excluded.
- Congestive heart failure patients on antibiotics or with infection.
- Congestive heart failure patients beyond 72 hours of presentation from enrolment. Intent is to capture congestive heart failure at the acute stage, prior to resolving.
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 |
|---|---|---|
| DevicePhase 1: Time taken for each patient is 25 mins Phase 2: Time taken for each patient is 30 mins | Device | Device Arm |
Primary outcome
Accuracy of this device on disease subjects in a clinical setting.
Time frame: 4.5 Months
The device will be compared against "gold-standard" manual counting and against existing technologies such as lead-based ECG, capnography and acoustic-based sensing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Dr Augustine Tee principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device in people with COPD, run by Changi General Hospital at 1 site in Singapore.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Jan 2020. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Yap (68502379, carolyn.yap.s.y@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of this device on disease subjects in a clinical setting. (time frame: 4.5 Months). 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 23 Jan 2020.