Validation of Respiratory Rate Monitor Versus CapnographyNCT04712240
Validating the Accuracy of a Continuous Respiratory Rate Measurement Device
A study testing Respiration rate monitor in people with Validation of Respiratory Rate Monitor Versus Capnography, run by University of Calgary at 1 site in Canada.
Trial summary
While respiratory rate is considered a critical vital sign, it often goes unmeasured or is ignored primarily due to shortcomings of the currently used measurement methods. Respiratory rate provides important information on a person's health condition and physiological stability, and an abnormal respiratory rate is a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Validation of Respiratory Rate Monitor Versus Capnography
- What is being tested?
- Respiration rate monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2021to 13 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants >= 18 years of age scheduled for elective surgery
- American Society of Anesthesiologists' Status Score <=3
Who cannot join
- Patients undergoing emergency surgery
- Patients undergoing abdominal procedures requiring skin prep of the lower chest area
- Patients undergoing breast surgery
- Patients undergoing shoulder surgery
- Patients with skin irritation in the area of monitor application
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Study Validating Accuracy of a Continuous Respiratory Rate Measurement Derived From a Respiratory Rate Monitoring Device (RRM): A Comparison With Capnography
While respiratory rate is considered a critical vital sign, it often goes unmeasured or is ignored primarily due to shortcomings of the currently used measurement methods. Respiratory rate provides important information on a person's health condition and physiological stability, and an abnormal respiratory rate is a strong indicator that a health crisis is imminent. In fact, a sudden change in respiratory rate is one of the strongest predictors of mortality. Current techniques of monitoring respiratory rate have drawbacks that limit the frequency and convenience of the respiratory monitoring. Recognizing that closer respiration monitoring can save lives and improve quality of life, reduce hospital stays, and lower medical costs, the health care industry is seeking improved respiration monitoring products. The allocation of high-risk patients to intensive care for more careful monitoring or after surgery is often arbitrary, and such care might not be available routinely. For those patients who are cared for in 'general' wards where staffing levels are limited, a practical continuous monitor of respiratory rate would be of great value. This study will act as a pilot to determine the feasibility of using respiratory sensor device to monitor respiratory rate in hospitalized patients.
Deriving a measurement of respiratory rate from a respiratory rate monitoring (RRM) device is a technological approach that may overcome these limitations. The device principle is based on a piezoelectric sensor where chest expansions and contractions generate very small amounts of current by the piezoelectric sensor. The expansion and contractions are measured very accurately by over-sampling, filtering and digital signal processing to remove noise and any bias generated by the piezoelectric sensor itself or the sampling circuitry.
The study will be conducted from March 2021 to September 2021. During the first phase a convenience sample of 30 patients undergoing general anesthesia with muscle paralysis and mechanical ventilation will be recruited. This phase will help to validate the RRM against capnography in mechanically ventilated patients with a set respiratory rate. Following the first phase, 120 patients undergoing a procedure using sedation or spinal anesthesia will be recruited. Patients will be breathing spontaneously, and the respiratory rate will be monitored by capnography connected to the face mask or nasal prongs. Respiratory rate detected by capnography is recorded in the electronic medical records on a minute to minute interval.
- Being tested
- Respiration rate monitor
- Keywords
- Respiration rate, Capnography, Continuous respiration rate monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiration rate monitorDevice
A portable continuously monitoring respiration rate monitor will be fitted to each participant. The respiration rate monitor is housed within a comfortable chest strap that be secured to the participant for the duration of the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Respiration rate monitor (concurrently measured with standard of care capnography) | Other | Single group study whereupon participants will be fitted with portable respiration rate monitor around their chest for duration of surgery. Respiration rates acquired by the respiration rate monitor will be compared to capnography, which is standard of care and applied to all surgical cases Receives: Device: Respiration rate monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of paired respiration rates within one breath per minute
Percentage of respiration rates measured by respiratory rate monitor that are within one breath per minute as measured by capnography
Measured: Respiration will be measured during the duration of participants' surgical procedure
Secondary outcomes (3)
Mean bias of errors
Mean bias of errors between respiration rates measured with respiratory rate monitor versus capnography
Measured: Respiration will be measured during the duration of participants' surgical procedure
Standard deviation of errors
Standard deviation of errors between respiration rates measured with respiratory rate monitor versus capnography
Measured: Respiration will be measured during the duration of participants' surgical procedure
Root mean square deviation of respiratory rate measurements
Measured: Respiration will be measured during the duration of participants' surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start17 Nov 2021
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation of Respiratory Rate Monitor Versus CapnographyStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Model description
- Participants will wear a portable respiration rate monitor that records respiration rate continuously while their respiration rate is also concurrently monitored and recorded using capnography (gold standard)
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712240
- Sponsor's protocol ID
- REB20-2237
- Status last verified
- May 2022
- First submitted
- 13 Jan 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Study Validating Accuracy of a Continuous Respiratory Rate Measurement Derived From a Respiratory Rate Monitoring Device (RRM): A Comparison With Capnography
- ClinicalTrials.gov ID
- NCT04712240
- Acronym / sponsor ID
- REB20-2237
- Keywords
- Respiration rate, Capnography, Continuous respiration rate monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 15 Jan 2021 (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.
While respiratory rate is considered a critical vital sign, it often goes unmeasured or is ignored primarily due to shortcomings of the currently used measurement methods. Respiratory rate provides important information on a person's health condition and physiological stability, and an abnormal respiratory rate is a strong indicator that a health crisis is imminent. In fact, a sudden change in respiratory rate is one of the strongest predictors of mortality. Current techniques of monitoring respiratory rate have drawbacks that limit the frequency and convenience of the respiratory monitoring. Recognizing that closer respiration monitoring can save lives and improve quality of life, reduce hospital stays, and lower medical costs, the health care industry is seeking improved respiration monitoring products. The allocation of high-risk patients to intensive care for more careful monitoring or after surgery is often arbitrary, and such care might not be available routinely. For those patients who are cared for in 'general' wards where staffing levels are limited, a practical continuous monitor of respiratory rate would be of great value. This study will act as a pilot to determine the feasibility of using respiratory sensor device to monitor respiratory rate in hospitalized patients.
Deriving a measurement of respiratory rate from a respiratory rate monitoring (RRM) device is a technological approach that may overcome these limitations. The device principle is based on a piezoelectric sensor where chest expansions and contractions generate very small amounts of current by the piezoelectric sensor. The expansion and contractions are measured very accurately by over-sampling, filtering and digital signal processing to remove noise and any bias generated by the piezoelectric sensor itself or the sampling circuitry.
The study will be conducted from March 2021 to September 2021. During the first phase a convenience sample of 30 patients undergoing general anesthesia with muscle paralysis and mechanical ventilation will be recruited. This phase will help to validate the RRM against capnography in mechanically ventilated patients with a set respiratory rate. Following the first phase, 120 patients undergoing a procedure using sedation or spinal anesthesia will be recruited. Patients will be breathing spontaneously, and the respiratory rate will be monitored by capnography connected to the face mask or nasal prongs. Respiratory rate detected by capnography is recorded in the electronic medical records on a minute to minute interval.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will wear a portable respiration rate monitor that records respiration rate continuously while their respiration rate is also concurrently monitored and recorded using capnography (gold standard)
| Arm | Type | Receives |
|---|---|---|
| Respiration rate monitor (concurrently measured with standard of care capnography) | Other | Device: Respiration rate monitorSingle group study whereupon participants will be fitted with portable respiration rate monitor around their chest for duration of surgery. Respiration rates acquired by the respiration rate monitor will be compared to capnography, which is standard of care and applied to all surgical cases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult participants >= 18 years of age scheduled for elective surgery
- American Society of Anesthesiologists' Status Score <=3
Key exclusion criteria (6 listed)
- Patients undergoing emergency surgery
- Patients undergoing abdominal procedures requiring skin prep of the lower chest area
- Patients undergoing breast surgery
- Patients undergoing shoulder surgery
- Patients with skin irritation in the area of monitor application
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 |
|---|---|---|
| Respiration rate monitorA portable continuously monitoring respiration rate monitor will be fitted to each participant. The respiration rate monitor is housed within a comfortable chest strap that be secured to the participant for the duration of the surgical procedure | Device | Respiration rate monitor (concurrently measured with standard of care capnography) |
Primary outcome
Percentage of paired respiration rates within one breath per minute
Time frame: Respiration will be measured during the duration of participants' surgical procedure
Percentage of respiration rates measured by respiratory rate monitor that are within one breath per minute as measured by capnography
3 secondary outcomes
Mean bias of errors
Time frame: Respiration will be measured during the duration of participants' surgical procedure
Standard deviation of errors
Time frame: Respiration will be measured during the duration of participants' surgical procedure
Root mean square deviation of respiratory rate measurements
Time frame: Respiration will be measured during the duration of participants' surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiration rate monitor in people with Validation of Respiratory Rate Monitor Versus Capnography, run by University of Calgary at 1 site in Canada.
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 2 inclusion and 6 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 18 May 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of paired respiration rates within one breath per minute (time frame: Respiration will be measured during the duration of participants' surgical procedure). 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 18 May 2022.