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Clinical Trials/NCT05991843
NCT05991843
Completed
Not Applicable

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

Rijnstate Hospital1 site in 1 country25 target enrollmentAugust 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Rate
Sponsor
Rijnstate Hospital
Enrollment
25
Locations
1
Primary Endpoint
Respiratory rate by manual count
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 17, 2023
End Date
January 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Rijnstate Hospital
Responsible Party
Principal Investigator
Principal Investigator

Mark Koning

Anesthesiologist-intensivist, principal investigator

Rijnstate Hospital

Eligibility Criteria

Inclusion Criteria

  • healthy volunteers

Exclusion Criteria

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

Outcomes

Primary Outcomes

Respiratory rate by manual count

Time Frame: 30 seconds

Respiratory rate as measured by a physician

Respiratory rate by pressure variation

Time Frame: 30 seconds

Respiratory rate as measured by the pressure variation in the HFNC circuit.

Respiratory rate by ECG-derived measurement

Time Frame: 30 seconds.

Respiratory rate as measured by the ECG-derived impedance difference

Secondary Outcomes

  • Pressure difference during breathing(30 seconds.)

Study Sites (1)

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