Respiratory Rate Measured by Pressure Variation During HFNC

Is it Possible to Measure an Adequate Respiration Rate Using Pressure Variation During HFNC

Monitoring the respiratory rate is important during procedural sedation. Several methods of measuring the respiratory rate are available, but most are unreliable and the most reliable method (capnography) is not available during the use of High Flow Nasal Cannula (HFNC) oxygen. We hypothesize that measuring the pressure variation in the HFNC-circuit is a reliable method of measuring the respiratory rate.

An experimental study, using healthy volunteers that will breath in three guided respiratory rates, compares the measurements of respiratory rate by the pressure variation in the HFNC circuit with measurements of respiratory rate by an ECG-derived method and a manual count by an physician.

A secondary outcome will be the ability to measure the size of pressure difference, in order to determine its feasiblity to use it as a surrogate for tidal volume or respiratory effort.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Rate
• Intervention / Treatment: Behavioral: Instructions of breathing

Detailed Description

The healthy volunteers will be administered HFNC-oxygen and will be instructed to breath normally, rapidly and slowly for 30 seconds. This will be done at two HFNC flow rates (35 L/min and 70 L/min) and with an open and a closed mouth. During these 30 seconds the respiratory rate will be measured by pressure variation in the HFNC circuit, ECG-derived impedance difference and a manual count by a physician.

This will lead to 12 conditions, depending on HFNC flow (35 and 70 L/min), open or closed mouth and respiratory rate (normally, rapidly, slowly). The measurements of the respiratory rates wil be compared per HFNC flow and per open or closed mouth.

A secondary outcome will be the ability to measure the size of pressure difference, in order to determine its feasiblity to use it as a surrogate for tidal volume or respiratory effort.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• known neurodegenerative diseases
• Pregnancy
• Children (age <18)
• Upper airway obstruction

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
Experimental: Study cohort; The cohort of healthy volunteers, who will breath at three different respiratory rates, as guided by "normal", "slowly" and "rapid".	Behavioral: Instructions of breathing; Breathing normally, slowly and rapidly for 30 seconds with an open and a closed mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate by pressure variation	Respiratory rate as measured by the pressure variation in the HFNC circuit.	30 seconds
Respiratory rate by manual count	Respiratory rate as measured by a physician	30 seconds
Respiratory rate by ECG-derived measurement	Respiratory rate as measured by the ECG-derived impedance difference	30 seconds.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure difference during breathing	The pressure difference measured in the HFNC-circuit between inspiration and expiration in cmH2O as the mean value over the 30 seconds.	30 seconds.

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Investigators: Principal Investigator: Mark V Koning, MD, PhD, Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Actual): August 23, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: High Flow Nasal Cannula; Thrive
• Other Study ID Numbers: NL84438.091.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Available upon reasonable request.
• IPD Sharing Time Frame: Within 2 years
• IPD Sharing Access Criteria: Available upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No