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Respiratory Rate Measured by Pressure Variation During HFNC

R

Rijnstate Hospital

Status

Completed

Conditions

Respiratory Rate

Treatments

Behavioral: Instructions of breathing

Study type

Interventional

Funder types

Other

Identifiers

NCT05991843
NL84438.091.23

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy volunteers

Exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Study cohort
Experimental group
Description:
The cohort of healthy volunteers, who will breath at three different respiratory rates, as guided by "normal", "slowly" and "rapid".
Treatment:
Behavioral: Instructions of breathing

Trial contacts and locations

1

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Central trial contact

Jeffrey Miechels; Mark V Koning, MD, PhD

Data sourced from clinicaltrials.gov

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