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

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 Overview

• Status: Completed
• Conditions: Validation of Respiratory Rate Monitor Versus Capnography
• Intervention / Treatment: Device: Respiration rate monitor

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3M 1M4
      • South Health Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Respiration will be measured during the duration of participants' surgical procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean bias of errors	Mean bias of errors between respiration rates measured with respiratory rate monitor versus capnography	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	Respiration will be measured during the duration of participants' surgical procedure
Root mean square deviation of respiratory rate measurements		Respiration will be measured during the duration of participants' surgical procedure

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): January 13, 2022
• Study Completion (Actual): January 13, 2022

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Capnography; Respiration rate; Continuous respiration rate monitoring
• Other Study ID Numbers: REB20-2237

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No