Validating the Accuracy of a Continuous Respiratory Rate Measurement Device

NCT ID: NCT04712240

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2022-01-13

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.

Conditions

Validation of Respiratory Rate Monitor Versus Capnography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Respiration rate monitor (concurrently measured with standard of care capnography)

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

Group Type: OTHER

Respiration rate monitor

Intervention Type: DEVICE

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

Interventions

Respiration 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

South Health Campus

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB20-2237

Identifier Type: -

Identifier Source: org_study_id