Respiratory Rate Measured by Pressure Variation During HFNC

NCT05991843 | Completed

• 1 other identifier: NL84438.091.23
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Rate

Keywords

High Flow Nasal Cannula; Thrive

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Pressure difference during breathing

  30 seconds.

Study Arms (1)

Study cohort

EXPERIMENTAL

The cohort of healthy volunteers, who will breath at three different respiratory rates, as guided by "normal", "slowly" and "rapid".

Behavioral: Instructions of breathing

Interventions

Instructions of breathing BEHAVIORAL

Breathing normally, slowly and rapidly for 30 seconds with an open and a closed mouth.

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers

You may not qualify if:

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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

Location

Related 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 Dec;38(6):1397-1404. doi: 10.1007/s10877-024-01185-8. Epub 2024 Jun 12.

  PMID: 38867018 RESULT

Related Links

• Related Info

Study Officials

• Mark V Koning, MD, PhD

  Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist-intensivist, principal investigator

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 15, 2023
• Study Start: August 17, 2023
• Primary Completion: August 23, 2023
• Study Completion: January 31, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Within 2 years
• Access Criteria: Available upon reasonable request.

Locations

NL (1)