Respiratory Rate Measured by Pressure Variation During HFNC

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Respiratory Rate

Clinical Trial Details

NCT number	NCT05991843
Study type	Interventional
Source	Rijnstate Hospital
Contact
Status	Completed
Phase	N/A
Start date	August 17, 2023
Completion date	January 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03832205` - Validation of Respiratory Rate and Heart Rate Measurements by Capaciflectors Placed in Four Locations on the Chest
Completed	`NCT04506684` - Reveal LINQ Respiration Clinical Study
Completed	`NCT03685227` - A Closer Look at Yoga Nidra: Sleep Lab Analyses	N/A
Completed	`NCT04179279` - Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor
Completed	`NCT04077593` - On the PhonE Respiratory rAte Study (OPERA)
Completed	`NCT03750344` - ChroniSense Polso Wrist Worn Respiration Rate Validation Study	N/A
Completed	`NCT05366049` - The Effect of Methods Used in Oral Antipyretic Administration on the Vital Findings of the Child With Fever	N/A
Completed	`NCT03148873` - RespiraSense Versus Capnography & Manual Counting
Recruiting	`NCT05263791` - Evaluation the Non-Inferiority of Airmod to Capnostream™35	N/A
Completed	`NCT05246358` - Respiratory Rate Validation Study - ChroniSense Polso	N/A
Recruiting	`NCT05812378` - Respiratory Monitoring System Safety and Performance Study
Not yet recruiting	`NCT06292299` - The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
Recruiting	`NCT05022264` - Remote Investigation and Assessment of Vital Signs
Completed	`NCT06086769` - High Flow Oxygen Therapy Effect on Healthy Subjects	N/A
Completed	`NCT04104737` - Spire Medical Health Tag Respiratory Rate Validation in Adults	N/A
Completed	`NCT04064645` - Bora Band Respiration Rate Study	N/A
Completed	`NCT01472133` - Validation of Respiration Rate Algorithms	N/A
Completed	`NCT03306537` - Sensor Validation Study - Quality Assurance
Active, not recruiting	`NCT03750318` - Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital	N/A
Completed	`NCT03754231` - Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital	N/A