Respiratory Rate Measured by Pressure Variation During HFNC

Not Applicable

Completed

• Conditions: Respiratory Rate
• Interventions: Behavioral: Instructions of breathing

• Registration Number: NCT05991843
• Lead Sponsor: Rijnstate Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-07-30
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-15
• Study Start: 2023-08-17
• Primary Completion: 2023-08-23
• Study Completion: 2024-01-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study cohort	Instructions of breathing	The cohort of healthy volunteers, who will breath at three different respiratory rates, as guided by "normal", "slowly" and "rapid".

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands