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Completed

NCT Number: NCT05991843

Respiratory Rate Measured by Pressure Variation During HFNC

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.

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Key information

Conditions

Respiratory Rate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers

Exclusion criteria

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

Treatment and study plan

Instructions of breathing

Behavioral

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

Primary outcomes

  1. Respiratory rate by pressure variation

    Time frame: 30 seconds

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

  2. Respiratory rate by manual count

    Time frame: 30 seconds

    Respiratory rate as measured by a physician

  3. Respiratory rate by ECG-derived measurement

    Time frame: 30 seconds.

    Respiratory rate as measured by the ECG-derived impedance difference

Secondary outcomes

  1. Pressure difference during breathing

    Time frame: 30 seconds.

    The pressure difference measured in the HFNC-circuit between inspiration and expiration in cmH2O as the mean value over the 30 seconds.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 15, 2023
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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