High Flow NasalCamOptNCT04096183
Evaluation of Lung Volume Under Nasal High Flow With a Time of Flight Camera
A study testing Ventilation of healthy volunteers in people with High Flow Nasal and Time of Flight Camera, run by University Hospital, Brest at 1 site in France.
Trial summary
The effectiveness of Nasal High Flow therapy (NHF), in comparison with conventional oxygen therapy, is based on Positive Expiratory Pressure (PEP) and washout of dead space. Many authors have shown that peak expiratory pressure, expiratory plateau pressure, mean upper airway pressure and lung volume were significantly… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Flow Nasal, Time of Flight Camera, Lung Volume
- What is being tested?
- Ventilation of healthy volunteers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2019to 7 Nov 2019
- 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 and Major Volunteers
Who cannot join
- Nasopharyngeal obstruction, facial trauma, or other contraindication to the use of Nasal High Flow, pregnant woman, major incompetent, lack of consent.
Trial locations and contacts
1 site in 1 country.
About this study
The effectiveness of Nasal High Flow therapy (NHF), in comparison with conventional oxygen therapy, is based on Positive Expiratory Pressure (PEP) and washout of dead space.
Many authors have shown that peak expiratory pressure, expiratory plateau pressure, mean upper airway pressure and lung volume were significantly increased. It depends mainly on gas flow and mouth closure.
Read more
First, "Groves"showed in 2007 that mouth opening could vary nasopharyngeal pressure from 2.7 to 7.4 cmH20 to 60 L / min, like Parke did in 2009, with a pressure of 1.2 at 2.7 cmH2O at 35 L / min.
Then, "Parke" showed in 2011 and 2015, a nasopharyngeal pressure changing from 2.7 to 11.9 cmH20 by varying the flow rate from 30 to 100 L / min. "Bräunlich" also showed concordant results in 2018, from 1.6 to 2.3 cmH2O, changing flow rates from 20 to 40 L / min. "Corley" in 2011 found a pressure from -0.3 to 2.7 by passing from ambient air to high flow. "Okuda and Mauri's" work in 2017 on oesophageal pressures also contributed to this.
In addition, it has been proved that the Tidal Volume (TV) is proportional to the flow delivered. These measurements were carried out by impedancemetry, the results of which were extrapolated to Vt. Thus "Okuda" evaluated it at 685mL in ambient air and 968mL at 50L / min. In 2016, "Fraser" highlighted a TV increasing from 400 to 500 mL by increasing the flow rate to 30 L / min. "Parke" in 2015 described an exponential End Expiratory Lung Impedence (EELI) proportional to the flow rate, as did "Riera" in 2013 with a ratio of 1.26 between ambient air and NHF at 40 L / min, and "Corley" in 2011 (ratio of 1.25).
Actualy, Time-of-Flight (ToF) cameras, such as Kinect v2®, are increasingly used in the medical field, particularly to characterize respiratory movement.
Various authors have shown a good correlation between the values of TV obtained by spirometry (reference method) and those obtained with ToF camera. A study led in 2018, by "S. Nazir" in the Department of "Réanimation Médicale" at the University Hospital of Brest, evaluated the average errors less than 46mL, with 76% of measurements having an error less than 50 mL, which corresponds to the clinical limit.
Now having a non-invasive, safe, simple, reproducible, inexpensive, and allowing evaluation in clinical situations method ; the use of a Time-of-Flight camera to evaluate the breathing and its various parameters, is indicated.
In this innovative study, never performed in different respiratory conditions in vigilant patients with NHF, the lung volume will be evaluated by a Time-of-Flight camera.
Different clinical situations, and the different parameters influencing it, will be observed and compared with the results of previous studies.
These situations will be simulations ranging from a physiological state to an acute respiratory distress.
- Being tested
- Ventilation of healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation of healthy volunteersOther
Ventilation of healthy volunteers in different clinical situations
| Study group | Role | What they receive |
|---|---|---|
| Ventilation of healthy volunteers | Other | Not described Receives: Other: Ventilation of healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the pulmonary volume change
Changes on the pulmonary volume in different situations during 3 hours.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start24 Oct 2019
- Primary completion7 Nov 2019
- Study completion7 Nov 2019
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 High Flow NasalStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096183
- Sponsor's protocol ID
- 29BRC19.0070_CamOpt
- Acronym
- CamOpt
- Status last verified
- Nov 2019
- First submitted
- 18 Sep 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Le Moigne G, Nazir S, Pateau V, Courtois E, L'Her E. Noninvasive Tidal Volume Measurements, Using a Time-of-Flight Camera, Under High-Flow Nasal Cannula-A Physiological Evaluation, in Healthy Volunteers. Crit Care Med. 2022 Jan 1;50(1):e61-e70. doi: 10.1097/CCM.0000000000005183.
PubMed 34259664
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Volume Under Nasal High Flow With a Time of Flight Camera
- ClinicalTrials.gov ID
- NCT04096183
- Acronym / sponsor ID
- CamOpt / 29BRC19.0070_CamOpt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 19 Sep 2019 (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.
The effectiveness of Nasal High Flow therapy (NHF), in comparison with conventional oxygen therapy, is based on Positive Expiratory Pressure (PEP) and washout of dead space.
Many authors have shown that peak expiratory pressure, expiratory plateau pressure, mean upper airway pressure and lung volume were significantly increased. It depends mainly on gas flow and mouth closure.
First, "Groves"showed in 2007 that mouth opening could vary nasopharyngeal pressure from 2.7 to 7.4 cmH20 to 60 L / min, like Parke did in 2009, with a pressure of 1.2 at 2.7 cmH2O at 35 L / min.
Then, "Parke" showed in 2011 and 2015, a nasopharyngeal pressure changing from 2.7 to 11.9 cmH20 by varying the flow rate from 30 to 100 L / min. "Bräunlich" also showed concordant results in 2018, from 1.6 to 2.3 cmH2O, changing flow rates from 20 to 40 L / min. "Corley" in 2011 found a pressure from -0.3 to 2.7 by passing from ambient air to high flow. "Okuda and Mauri's" work in 2017 on oesophageal pressures also contributed to this.
In addition, it has been proved that the Tidal Volume (TV) is proportional to the flow delivered. These measurements were carried out by impedancemetry, the results of which were extrapolated to Vt. Thus "Okuda" evaluated it at 685mL in ambient air and 968mL at 50L / min. In 2016, "Fraser" highlighted a TV increasing from 400 to 500 mL by increasing the flow rate to 30 L / min. "Parke" in 2015 described an exponential End Expiratory Lung Impedence (EELI) proportional to the flow rate, as did "Riera" in 2013 with a ratio of 1.26 between ambient air and NHF at 40 L / min, and "Corley" in 2011 (ratio of 1.25).
Actualy, Time-of-Flight (ToF) cameras, such as Kinect v2®, are increasingly used in the medical field, particularly to characterize respiratory movement.
Various authors have shown a good correlation between the values of TV obtained by spirometry (reference method) and those obtained with ToF camera. A study led in 2018, by "S. Nazir" in the Department of "Réanimation Médicale" at the University Hospital of Brest, evaluated the average errors less than 46mL, with 76% of measurements having an error less than 50 mL, which corresponds to the clinical limit.
Now having a non-invasive, safe, simple, reproducible, inexpensive, and allowing evaluation in clinical situations method ; the use of a Time-of-Flight camera to evaluate the breathing and its various parameters, is indicated.
In this innovative study, never performed in different respiratory conditions in vigilant patients with NHF, the lung volume will be evaluated by a Time-of-Flight camera.
Different clinical situations, and the different parameters influencing it, will be observed and compared with the results of previous studies.
These situations will be simulations ranging from a physiological state to an acute respiratory distress.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventilation of healthy volunteers | Other | Other: Ventilation of healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy and Major Volunteers
Key exclusion criteria (1 listed)
- Nasopharyngeal obstruction, facial trauma, or other contraindication to the use of Nasal High Flow, pregnant woman, major incompetent, lack of consent.
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 |
|---|---|---|
| Ventilation of healthy volunteersVentilation of healthy volunteers in different clinical situations | Other | Ventilation of healthy volunteers |
Primary outcome
Evaluation of the pulmonary volume change
Time frame: 3 hours
Changes on the pulmonary volume in different situations during 3 hours.
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 20 Nov 2019.
- Derived from this study: PubMed 34259664Le Moigne G, Nazir S, Pateau V, Courtois E, L'Her E. Noninvasive Tidal Volume Measurements, Using a Time-of-Flight Camera, Under High-Flow Nasal Cannula-A Physiological Evaluation, in Healthy Volunteers. Crit Care Med. 2022 Jan 1;50(1):e61-e70. doi: 10.1097/CCM.0000000000005183.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for High Flow Nasal
RecruitingObservational study
Predicting High-Flow Nasal Oxygen Failure Within 72 Hours Using a Physiology-Informed Dual-Domain Model at 30 Minutes
Acute Respiratory Failure, Electrical Impedance Tomography (EIT)
Not yet recruiting
Protocolized Weaning of High-Flow Nasal Cannula in Adult Patients
Acute Hypoxemic Respiratory Failure, High-Flow Nasal Cannula Therapy
Not yet recruitingObservational study
HERMES: Quality and Safety of Advanced Respiratory Support During Patient Transport
Acute Respiratory Failure, Respiratory Insufficiency
RecruitingObservational study
Heart Rate VAriability as a MaRker for tItrATing hIgh flOw Nasal Cannula Therapy
Respiratory Failure, Heart Rate Variability (HRV)
Not yet recruiting
HFNO Flow Rates and Cerebral Oxygenation During Deep Sedation for Cystoscopy
Deep Sedation, High Flow Nasal Canula
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation of healthy volunteers in people with High Flow Nasal and Time of Flight Camera, run by University Hospital, Brest at 1 site in France.
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 1 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 20 Nov 2019. 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 France. 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?
Evaluation of the pulmonary volume change (time frame: 3 hours). 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 NCT04096183, 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 20 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.