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Respiratory Rate Measured by Pressure Variation During HFNC

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05991843
Enrollment
25
Registered
2023-08-15
Start date
2023-08-17
Completion date
2024-01-31
Last updated
2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Rate

Keywords

High Flow Nasal Cannula, Thrive

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.

Interventions

BEHAVIORALInstructions of breathing

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

Sponsors

Rijnstate Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* healthy volunteers

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory rate by pressure variation30 secondsRespiratory rate as measured by the pressure variation in the HFNC circuit.
Respiratory rate by manual count30 secondsRespiratory rate as measured by a physician
Respiratory rate by ECG-derived measurement30 seconds.Respiratory rate as measured by the ECG-derived impedance difference

Secondary

MeasureTime frameDescription
Pressure difference during breathing30 seconds.The pressure difference measured in the HFNC-circuit between inspiration and expiration in cmH2O as the mean value over the 30 seconds.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026