Respiratory RateNCT05991843
Respiratory Rate Measured by Pressure Variation During HFNC
A study testing Instructions of breathing in people with Respiratory Rate, run by Rijnstate Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Rate
- What is being tested?
- Instructions of breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Aug 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- known neurodegenerative diseases
- Pregnancy
- Children (age <18)
- Upper airway obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is it Possible to Measure an Adequate Respiration Rate Using 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.
Read the 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.
- Conditions
- Respiratory Rate
- Being tested
- Instructions of breathing
- Keywords
- High Flow Nasal Cannula, Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructions of breathingBehavioural
Breathing normally, slowly and rapidly for 30 seconds with an open and a closed mouth.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Experimental | The cohort of healthy volunteers, who will breath at three different respiratory rates, as guided by "normal", "slowly" and "rapid". Receives: Behavioral: Instructions of breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate by pressure variation
Respiratory rate as measured by the pressure variation in the HFNC circuit.
Measured: 30 seconds
Respiratory rate by manual count
Respiratory rate as measured by a physician
Measured: 30 seconds
Respiratory rate by ECG-derived measurement
Respiratory rate as measured by the ECG-derived impedance difference
Measured: 30 seconds.
Secondary outcomes (1)
Pressure difference during breathing
The pressure difference measured in the HFNC-circuit between inspiration and expiration in cmH2O as the mean value over the 30 seconds.
Measured: 30 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start17 Aug 2023
- Primary completion23 Aug 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Koning, Rijnstate Hospital
- Investigators
- Mark V Koning, MD, PhD, Principal investigator, Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991843
- Sponsor's protocol ID
- NL84438.091.23
- Status last verified
- Jun 2024
- First submitted
- 30 Jul 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon reasonable request.
Publications
Miechels J, Koning MV. Respiratory rate measurement by pressure variation in the high flow nasal cannula-system in healthy volunteers. J Clin Monit Comput. 2024 Dec;38(6):1397-1404. doi: 10.1007/s10877-024-01185-8. Epub 2024 Jun 12.
PubMed 38867018
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Possible to Measure an Adequate Respiration Rate Using Pressure Variation During HFNC
- ClinicalTrials.gov ID
- NCT05991843
- Acronym / sponsor ID
- NL84438.091.23
- Conditions
- Respiratory Rate
- Keywords
- High Flow Nasal Cannula, Thrive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | Experimental | Behavioral: Instructions of breathingThe cohort of healthy volunteers, who will breath at three different respiratory rates, as guided by "normal", "slowly" and "rapid". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (4 listed)
- known neurodegenerative diseases
- Pregnancy
- Children (age <18)
- Upper airway obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instructions of breathingBreathing normally, slowly and rapidly for 30 seconds with an open and a closed mouth. | Behavioural | Study cohort |
Primary outcome
Respiratory rate by pressure variation
Time frame: 30 seconds
Respiratory rate as measured by the pressure variation in the HFNC circuit.
Respiratory rate by manual count
Time frame: 30 seconds
Respiratory rate as measured by a physician
Respiratory rate by ECG-derived measurement
Time frame: 30 seconds.
Respiratory rate as measured by the ECG-derived impedance difference
1 secondary outcome
Pressure difference during breathing
Time frame: 30 seconds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Results publication: PubMed 38867018Miechels J, Koning MV. Respiratory rate measurement by pressure variation in the high flow nasal cannula-system in healthy volunteers. J Clin Monit Comput. 2024 Dec;38(6):1397-1404. doi: 10.1007/s10877-024-01185-8. Epub 2024 Jun 12.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark V Koning, MD, PhD principal investigator
Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructions of breathing in people with Respiratory Rate, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate by pressure variation (time frame: 30 seconds). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05991843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.