High-Flow Nasal CannulaiFLOWNCT05401474
Individualization Flow in Patients Treated With High Flow Nasal Therapy (iFLOW)
A study testing High Flow Nasal Cannula at 30L/min, High Flow Nasal Cannula at 45L/min and High Flow Nasal Cannula at 60L/min in people with High-Flow Nasal Cannula and Oxygen Therapy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
In patients with acute hypoxemic respiratory failure (AHRF), High Flow Nasal Therapy (HFNT) improves oxygenation, tolerance, and decreases work of breathing as compared to standard oxygen therapy by facemask. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-Flow Nasal Cannula, Oxygen Therapy, Acute Respiratory Failure
- What is being tested?
- High Flow Nasal Cannula at 30L/min, High Flow Nasal Cannula at 45L/min and High Flow Nasal Cannula at 60L/min
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 18 Mar 2022to 28 Feb 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient admitted to the ICU requiring NHF due to AHRF that will be defined as an SpO2/FIO2 ratio <315
Who cannot join
- Patient with indication for immediate CPAP, NIV, or invasive mechanical ventilation
- Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h
- Severe acidosis (pH ≤ 7.25)
- Pregnant woman
- Tracheotomised patient
- Formalized ethical decision to withhold or withdraw life support
Show all 10Show fewer
- Patient under guardianship
- Patient deprived of liberties
- Patient already enrolled in the present study in a previous episode of acute respiratory failure
- Patient who does not consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Oriol Roca, MD PhD, +34932746209, oroca@vhebron.net
Francisco Ramos, MD, +34932746209, f.ramos@vhebron.net
About this study
Official title: Assessing Recruitability for Flow Individualization in Patients Treated With Nasal High Flow: a Physiological Study (The iFLOW Study)
In patients with acute hypoxemic respiratory failure (AHRF), High Flow Nasal Therapy (HFNT) improves oxygenation, tolerance, and decreases work of breathing as compared to standard oxygen therapy by facemask.
The hypothesis is that this flow challenge (ROX index variation from 30 to 60L/min) could be used as a test for assessing changes in lung aeration, analyzed by the variation in end expiratory lung volume (ΔEELV), in patients treated with HFNC. It may allow to personalize the flow settings during HFNC. In this sense, an increase in EELV will be observed with higher flows in responders and, therefore, these participants may benefit from increasing the flow. In contrast, to increase the flow in non-responders (no significant increase in EELV with higher flows) increase the risk of patient self-inflicted lung injury (P-SILI).
- Conditions
- High-Flow Nasal Cannula, Oxygen Therapy, Acute Respiratory Failure, Respiratory Failure, Lung Injury
- Being tested
- High Flow Nasal Cannula at 30L/min, High Flow Nasal Cannula at 45L/min, High Flow Nasal Cannula at 60L/min
- Keywords
- High-Flow Nasal Cannula, Oxygen therapy, Electrical Impedance Tomography, Lung injury, Acute Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Cannula at 30L/minDevice
Flow will be set at 30L/min, FiO2 will be adjusted manually to maintain SpO2within the target range
High Flow Nasal Cannula at 45L/minDevice
Flow will be set at 45L/min, FiO2 will be adjusted manually to maintain SpO2within the target range
High Flow Nasal Cannula at 60L/minDevice
Flow will be set at 60L/min, FiO2 will be adjusted manually to maintain SpO2within the target range
| Study group | Role | What they receive |
|---|---|---|
| 30 L/min | Active comparator | HFNC at 30L/min. FiO2 adjusted to reach SpO2 95% Receives: Device: High Flow Nasal Cannula at 30L/min |
| 45 L/min | Experimental | HFNC at 45L/min. FiO2 adjusted to reach SpO2 95% Receives: Device: High Flow Nasal Cannula at 45L/min |
| 60 L/min | Experimental | HFNC at 60L/min. FiO2 adjusted to reach SpO2 95% Receives: Device: High Flow Nasal Cannula at 60L/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the correlation between the change in ROX index and the change in EELV
Change in ROX is defined as the difference in ROX index (SpO2/FiO2/respiratory rate) between 2 flows. Change in EELV is the difference in End-Expiratory Lung Volume as determined by EIT.
Measured: 20 minutes
Secondary outcomes (6)
To assess the changes in aeration distribution (by the variable center of ventilation (CoV)) measured by EIT at different flows (30L/min, 45 L/min and 60L/min).
Lung aeration as defined by the variable center of ventilation (CoV) in EIT.
Measured: 20 minutes
To assess the changes in lung homogeneity (by the variable global inhomogeneity index (GI)) measured by EIT at differents flows (30L/min, 45 L/min and 60L/min).
Lung homogeneity as defined by global inhomogeneity index (GI) by EIT
Measured: 20 minutes
To analyze the differences in SpO2 at different flows
SpO2 by pulseoxymetry
Measured: 20 minutes
To analyze the differences in respiratory rate at different flows
Breaths/minute
Measured: 20 minutes
To analyze the differences in the FiO2 used at different flows
FiO2 will be titrated manually to achieve a predefined SpO2 range (92 - 96%; 88-92% for patients with chronic respiratory disease)
Measured: 20 minutes
To analyze the differences in patient comfort at different flows, using the visual analogic scale (from 0 to 10)
Comfort score by visual analogic scale. From 0 (worst outcome) to 10 (best outocome).
Measured: 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start18 Mar 2022
- Primary completion5 Nov 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for High-Flow Nasal CannulaStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401474
- Sponsor's protocol ID
- PR(AG)21/2022
- Acronym
- iFLOW
- Status last verified
- May 2022
- First submitted
- 5 Apr 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ricard JD, Roca O, Lemiale V, Corley A, Braunlich J, Jones P, Kang BJ, Lellouche F, Nava S, Rittayamai N, Spoletini G, Jaber S, Hernandez G. Use of nasal high flow oxygen during acute respiratory failure. Intensive Care Med. 2020 Dec;46(12):2238-2247. doi: 10.1007/s00134-020-06228-7. Epub 2020 Sep 8.
PubMed 32901374Mauri T, Alban L, Turrini C, Cambiaghi B, Carlesso E, Taccone P, Bottino N, Lissoni A, Spadaro S, Volta CA, Gattinoni L, Pesenti A, Grasselli G. Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31.
PubMed 28762180Roca O, Messika J, Caralt B, Garcia-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.
PubMed 27481760Bachmann MC, Morais C, Bugedo G, Bruhn A, Morales A, Borges JB, Costa E, Retamal J. Electrical impedance tomography in acute respiratory distress syndrome. Crit Care. 2018 Oct 25;22(1):263. doi: 10.1186/s13054-018-2195-6.
PubMed 30360753
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Recruitability for Flow Individualization in Patients Treated With Nasal High Flow: a Physiological Study (The iFLOW Study)
- ClinicalTrials.gov ID
- NCT05401474
- Acronym / sponsor ID
- iFLOW / PR(AG)21/2022
- Conditions
- High-Flow Nasal Cannula, Oxygen Therapy, Acute Respiratory Failure, Respiratory Failure, Lung Injury
- Keywords
- High-Flow Nasal Cannula, Oxygen therapy, Electrical Impedance Tomography, Lung injury, Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 5 Nov 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
In patients with acute hypoxemic respiratory failure (AHRF), High Flow Nasal Therapy (HFNT) improves oxygenation, tolerance, and decreases work of breathing as compared to standard oxygen therapy by facemask.
The hypothesis is that this flow challenge (ROX index variation from 30 to 60L/min) could be used as a test for assessing changes in lung aeration, analyzed by the variation in end expiratory lung volume (ΔEELV), in patients treated with HFNC. It may allow to personalize the flow settings during HFNC. In this sense, an increase in EELV will be observed with higher flows in responders and, therefore, these participants may benefit from increasing the flow. In contrast, to increase the flow in non-responders (no significant increase in EELV with higher flows) increase the risk of patient self-inflicted lung injury (P-SILI).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30 L/min | Active comparator | Device: High Flow Nasal Cannula at 30L/minHFNC at 30L/min. FiO2 adjusted to reach SpO2 95% |
| 45 L/min | Experimental | Device: High Flow Nasal Cannula at 45L/minHFNC at 45L/min. FiO2 adjusted to reach SpO2 95% |
| 60 L/min | Experimental | Device: High Flow Nasal Cannula at 60L/minHFNC at 60L/min. FiO2 adjusted to reach SpO2 95% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient admitted to the ICU requiring NHF due to AHRF that will be defined as an SpO2/FIO2 ratio <315
Key exclusion criteria (10 listed)
- Patient with indication for immediate CPAP, NIV, or invasive mechanical ventilation
- Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h
- Severe acidosis (pH ≤ 7.25)
- Pregnant woman
- Tracheotomised patient
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 |
|---|---|---|
| High Flow Nasal Cannula at 30L/minFlow will be set at 30L/min, FiO2 will be adjusted manually to maintain SpO2within the target range | Device | 30 L/min |
| High Flow Nasal Cannula at 45L/minFlow will be set at 45L/min, FiO2 will be adjusted manually to maintain SpO2within the target range | Device | 45 L/min |
| High Flow Nasal Cannula at 60L/minFlow will be set at 60L/min, FiO2 will be adjusted manually to maintain SpO2within the target range | Device | 60 L/min |
Primary outcome
To validate the correlation between the change in ROX index and the change in EELV
Time frame: 20 minutes
Change in ROX is defined as the difference in ROX index (SpO2/FiO2/respiratory rate) between 2 flows. Change in EELV is the difference in End-Expiratory Lung Volume as determined by EIT.
6 secondary outcomes
To assess the changes in aeration distribution (by the variable center of ventilation (CoV)) measured by EIT at different flows (30L/min, 45 L/min and 60L/min).
Time frame: 20 minutes
To assess the changes in lung homogeneity (by the variable global inhomogeneity index (GI)) measured by EIT at differents flows (30L/min, 45 L/min and 60L/min).
Time frame: 20 minutes
To analyze the differences in SpO2 at different flows
Time frame: 20 minutes
To analyze the differences in respiratory rate at different flows
Time frame: 20 minutes
To analyze the differences in the FiO2 used at different flows
Time frame: 20 minutes
To analyze the differences in patient comfort at different flows, using the visual analogic scale (from 0 to 10)
Time frame: 20 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Background: PubMed 32901374Ricard JD, Roca O, Lemiale V, Corley A, Braunlich J, Jones P, Kang BJ, Lellouche F, Nava S, Rittayamai N, Spoletini G, Jaber S, Hernandez G. Use of nasal high flow oxygen during acute respiratory failure. Intensive Care Med. 2020 Dec;46(12):2238-2247. doi: 10.1007/s00134-020-06228-7. Epub 2020 Sep 8.
- Background: PubMed 28762180Mauri T, Alban L, Turrini C, Cambiaghi B, Carlesso E, Taccone P, Bottino N, Lissoni A, Spadaro S, Volta CA, Gattinoni L, Pesenti A, Grasselli G. Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31.
- Background: PubMed 27481760Roca O, Messika J, Caralt B, Garcia-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.
- Background: PubMed 30360753Bachmann MC, Morais C, Bugedo G, Bruhn A, Morales A, Borges JB, Costa E, Retamal J. Electrical impedance tomography in acute respiratory distress syndrome. Crit Care. 2018 Oct 25;22(1):263. doi: 10.1186/s13054-018-2195-6.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula at 30L/min, High Flow Nasal Cannula at 45L/min and High Flow Nasal Cannula at 60L/min in people with High-Flow Nasal Cannula and Oxygen Therapy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 10 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: status not confirmed, as of the sponsor's last update on 2 Jun 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oriol Roca, MD PhD (+34932746209, oroca@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the correlation between the change in ROX index and the change in EELV (time frame: 20 minutes). 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 NCT05401474, which also lists 4 linked publications.
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 2 Jun 2022.