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Validating the Accuracy of a Continuous Respiratory Rate Measurement Device

A Single Center Study Validating Accuracy of a Continuous Respiratory Rate Measurement Derived From a Respiratory Rate Monitoring Device (RRM): A Comparison With Capnography

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04712240
Enrollment
169
Registered
2021-01-15
Start date
2021-11-17
Completion date
2022-01-13
Last updated
2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validation of Respiratory Rate Monitor Versus Capnography

Keywords

Respiration rate, Capnography, Continuous respiration rate monitoring

Brief 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 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.

Interventions

DEVICERespiration rate monitor

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

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

Participant, care giver, investigator and outcomes assessor will be aware that all participants are wearing a portable respiration rate monitor whose measurements will be compared to the gold standard of capnography

Intervention 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)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult participants \>= 18 years of age scheduled for elective surgery * American Society of Anesthesiologists' Status Score \<=3

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of paired respiration rates within one breath per minuteRespiration will be measured during the duration of participants' surgical procedurePercentage of respiration rates measured by respiratory rate monitor that are within one breath per minute as measured by capnography

Secondary

MeasureTime frameDescription
Mean bias of errorsRespiration will be measured during the duration of participants' surgical procedureMean bias of errors between respiration rates measured with respiratory rate monitor versus capnography
Standard deviation of errorsRespiration will be measured during the duration of participants' surgical procedureStandard deviation of errors between respiration rates measured with respiratory rate monitor versus capnography
Root mean square deviation of respiratory rate measurementsRespiration will be measured during the duration of participants' surgical procedure

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026