Respiratory Rate Measured by Pressure Variation During HFNC

Respiratory Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05991843
• Other study ID #: NL84438.091.23
• Status: Completed
• Phase: N/A
• Start date: August 17, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2024
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 31, 2024
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• known neurodegenerative diseases

• Pregnancy

• Children (age <18)

• Upper airway obstruction

Related Conditions & MeSH terms

• Respiratory Rate

Intervention

Behavioral:
• Instructions of breathing
Breathing normally, slowly and rapidly for 30 seconds with an open and a closed mouth.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Miechels J, Koning MV. Respiratory rate measurement by pressure variation in the high flow nasal cannula-system in healthy volunteers. J Clin Monit Comput. 2024 Jun 12. doi: 10.1007/s10877-024-01185-8. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate by pressure variation	Respiratory rate as measured by the pressure variation in the HFNC circuit.	30 seconds
Primary	Respiratory rate by manual count	Respiratory rate as measured by a physician	30 seconds
Primary	Respiratory rate by ECG-derived measurement	Respiratory rate as measured by the ECG-derived impedance difference	30 seconds.
Secondary	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.

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