Hypoxemic Respiratory FailureNCT04971148
Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia
A study testing HFNC flow set at patient peak tidal inspiratory flow, HFNC flow set at 1.33 times of patient peak tidal inspiratory flow and HFNC flow set at 1.67 times of patient peak tidal inspiratory flow in people with Hypoxemic Respiratory Failure, run by Rush University Medical Center at 2 sites in 2 countries.
Trial summary
In this study, patients who are ready for extubation and indicated for high-flow nasal cannula therapy after extubation will be enrolled, the investigators would measure the patient peak tidal inspiratory flow (PTIF) pre and post extubation to explore the correlation between the two PTIFs. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypoxemic Respiratory Failure
- What is being tested?
- HFNC flow set at patient peak tidal inspiratory flow, HFNC flow set at 1.33 times of patient peak tidal inspiratory flow and HFNC flow set at 1.67 times of patient peak tidal inspiratory flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Apr 2022to 8 Aug 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult intubated patients aged between 18 to 90 years
- Pass spontaneous breathing trial and receive the order to be extubated
- Have at least one of the indications to use HFNC after extubation
Who cannot join
- Need to use inhaled epoprostenol via HFNC
- Pregnant
- Unable to use resuscitation mask, such as facial trauma, claustrophobia
- Non-English speaker
- Inability to verbally communicate
- Using extracorporeal membrane oxygenation (ECMO)
- Hemodynamically unstable
- Difficult airway
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Rush university medical center
Chicago, Illinois, 60612
About this study
Official title: Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia, and Patients' Responses to Different Flows Above Their Peak Tidal Inspiratory Flow During High Flow Nasal Cannula Therapy
In this study, patients who are ready for extubation and indicated for high-flow nasal cannula therapy after extubation will be enrolled, the investigators would measure the patient peak tidal inspiratory flow (PTIF) pre and post extubation to explore the correlation between the two PTIFs. Moreover, different HFNC flows would be applied, to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.
Read the detailed description
High-flow nasal cannula (HFNC) oxygen therapy has been shown to improve oxygenation, reduce the need for intubation for patients with acute hypoxemic respiratory failure (AHRF) and avoid reintubation for post-extubation patients who had high-risk factors. HFNC refers to the delivery of gas at flows that exceed the patient peak inspiratory flow during tidal breathing, However, patient peak tidal inspiratory flow (PTIF) is found to vary greatly among different patients, from 20 to 50 L/min, making it difficult to properly set HFNC in a way to achieve the desired effects. In two recently published studies in intubated patients, PTIF varied from 25-65 L/min or 40-80 L/min, thus this study aims to investigate the correlation between pre-extubation PTIF in different modalities of SBT and post-extubation PTIF for adult patients, who are indicated to use HFNC immediately after extubation. In addition, the investigators aim to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.
- Conditions
- Hypoxemic Respiratory Failure
- Being tested
- HFNC flow set at patient peak tidal inspiratory flow, HFNC flow set at 1.33 times of patient peak tidal inspiratory flow, HFNC flow set at 1.67 times of patient peak tidal inspiratory flow, HFNC flow set at 2 times of patient peak tidal inspiratory flow
- Keywords
- high-flow nasal cannula, flow setting, peak tidal inspiratory flow, hypoxemia
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNC flow set at patient peak tidal inspiratory flowOther
HFNC flow will be set at the level equal to patient peak tidal inspiratory flow
HFNC flow set at 1.33 times of patient peak tidal inspiratory flowOther
HFNC flow will be set at 1.33 times of patient peak tidal inspiratory flow
HFNC flow set at 1.67 times of patient peak tidal inspiratory flowOther
HFNC flow will be set at 1.67 times of patient peak tidal inspiratory flow
HFNC flow set at 2 times of patient peak tidal inspiratory flowOther
HFNC flow will be set 2 times of patient peak tidal inspiratory flow
| Study group | Role | What they receive |
|---|---|---|
| HFNC flow set at patient peak tidal inspiratory flow | Active comparator | HFNC flow will be set at the level that matches patient peak tidal inspiratory flow Receives: Other: HFNC flow set at patient peak tidal inspiratory flow |
| HFNC flow set at 1.33 times of patient peak tidal inspiratory flow | Experimental | HFNC flow will be set at the level that is 1.33 times of patient peak tidal inspiratory flow Receives: Other: HFNC flow set at 1.33 times of patient peak tidal inspiratory flow |
| HFNC flow set at 1.67 times of patient peak tidal inspiratory flow | Experimental | HFNC flow will be set at the level that is 1.67 times of patient peak tidal inspiratory flow Receives: Other: HFNC flow set at 1.67 times of patient peak tidal inspiratory flow |
| HFNC flow set at 2 times of patient peak tidal inspiratory flow | Experimental | HFNC flow will be set at the level that is 2 times of patient peak tidal inspiratory flow Receives: Other: HFNC flow set at 2 times of patient peak tidal inspiratory flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2/FIO2
Twenty mins after each flow setting, pulse oximetry divided by fraction of inspired oxygen will be used to assess patient's oxygenation response to different flow
Measured: 20 minutes after each flow setting
Secondary outcomes (2)
End-expiratory lung volume assessed by EIT
Twenty mins after each flow setting, electrical impedance tomography (EIT) will be used to assess patient's end -expiratory lung volume 20 mins after each flow setting
Measured: 20 minutes after each flow setting
self-evaluated comfort
Twenty mins after each flow setting, patient comfort will be assessed using a visual numerical scale with a score of 0 as the worst and 10 as the best comfort
Measured: 20 minutes after each flow setting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start7 Apr 2022
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Why it stopped: Difficulty in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be randomized to receive different HFNC flow settings (matching their peak tidal inspiratory flow \[PTIF\], 1.33 times of PTIF, 1.67 times of PTIF and 2 times of PTIF)
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron
- Responsible party
- Sponsor
- Investigators
- Jie Li, PhD, Principal investigator, Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971148
- Sponsor's protocol ID
- HFNC-Flow-004
- Status last verified
- Aug 2023
- First submitted
- 12 Jul 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified patient data will be shared upon reasonable request 3 months after publication.
Publications
Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
PubMed 25981908Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.
PubMed 30888444Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
PubMed 27706464Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
PubMed 26975498Yasuda H, Okano H, Mayumi T, Narita C, Onodera Y, Nakane M, Shime N. Post-extubation oxygenation strategies in acute respiratory failure: a systematic review and network meta-analysis. Crit Care. 2021 Apr 9;25(1):135. doi: 10.1186/s13054-021-03550-4.
PubMed 33836812Butt S, Pistidda L, Floris L, Liperi C, Vasques F, Glover G, Barrett NA, Sanderson B, Grasso S, Shankar-Hari M, Camporotaa L. Initial setting of high-flow nasal oxygen post extubation based on mean inspiratory flow during a spontaneous breathing trial. J Crit Care. 2021 Jun;63:40-44. doi: 10.1016/j.jcrc.2020.12.022. Epub 2020 Dec 27.
PubMed 33621890Mauri T, Spinelli E, Dalla Corte F, Scotti E, Turrini C, Lazzeri M, Alban L, Albanese M, Tortolani D, Wang YM, Spadaro S, Zhou JX, Pesenti A, Grasselli G. Noninvasive assessment of airflows by electrical impedance tomography in intubated hypoxemic patients: an exploratory study. Ann Intensive Care. 2019 Jul 22;9(1):83. doi: 10.1186/s13613-019-0560-5.
PubMed 31332551Mauri 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 28762180Li J, Jing G, Scott JB. Year in Review 2019: High-Flow Nasal Cannula Oxygen Therapy for Adult Subjects. Respir Care. 2020 Apr;65(4):545-557. doi: 10.4187/respcare.07663.
PubMed 32213602Li J, Scott JB, Fink JB, Reed B, Roca O, Dhand R. Optimizing high-flow nasal cannula flow settings in adult hypoxemic patients based on peak inspiratory flow during tidal breathing. Ann Intensive Care. 2021 Nov 27;11(1):164. doi: 10.1186/s13613-021-00949-8.
PubMed 34837553
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia, and Patients' Responses to Different Flows Above Their Peak Tidal Inspiratory Flow During High Flow Nasal Cannula Therapy
- ClinicalTrials.gov ID
- NCT04971148
- Acronym / sponsor ID
- HFNC-Flow-004
- Conditions
- Hypoxemic Respiratory Failure
- Keywords
- high-flow nasal cannula, flow setting, peak tidal inspiratory flow, hypoxemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 21 Jul 2021 (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 this study, patients who are ready for extubation and indicated for high-flow nasal cannula therapy after extubation will be enrolled, the investigators would measure the patient peak tidal inspiratory flow (PTIF) pre and post extubation to explore the correlation between the two PTIFs. Moreover, different HFNC flows would be applied, to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.
Detailed description
High-flow nasal cannula (HFNC) oxygen therapy has been shown to improve oxygenation, reduce the need for intubation for patients with acute hypoxemic respiratory failure (AHRF) and avoid reintubation for post-extubation patients who had high-risk factors. HFNC refers to the delivery of gas at flows that exceed the patient peak inspiratory flow during tidal breathing, However, patient peak tidal inspiratory flow (PTIF) is found to vary greatly among different patients, from 20 to 50 L/min, making it difficult to properly set HFNC in a way to achieve the desired effects. In two recently published studies in intubated patients, PTIF varied from 25-65 L/min or 40-80 L/min, thus this study aims to investigate the correlation between pre-extubation PTIF in different modalities of SBT and post-extubation PTIF for adult patients, who are indicated to use HFNC immediately after extubation. In addition, the investigators aim to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients will be randomized to receive different HFNC flow settings (matching their peak tidal inspiratory flow [PTIF], 1.33 times of PTIF, 1.67 times of PTIF and 2 times of PTIF)
| Arm | Type | Receives |
|---|---|---|
| HFNC flow set at patient peak tidal inspiratory flow | Active comparator | Other: HFNC flow set at patient peak tidal inspiratory flowHFNC flow will be set at the level that matches patient peak tidal inspiratory flow |
| HFNC flow set at 1.33 times of patient peak tidal inspiratory flow | Experimental | Other: HFNC flow set at 1.33 times of patient peak tidal inspiratory flowHFNC flow will be set at the level that is 1.33 times of patient peak tidal inspiratory flow |
| HFNC flow set at 1.67 times of patient peak tidal inspiratory flow | Experimental | Other: HFNC flow set at 1.67 times of patient peak tidal inspiratory flowHFNC flow will be set at the level that is 1.67 times of patient peak tidal inspiratory flow |
| HFNC flow set at 2 times of patient peak tidal inspiratory flow | Experimental | Other: HFNC flow set at 2 times of patient peak tidal inspiratory flowHFNC flow will be set at the level that is 2 times of patient peak tidal inspiratory flow |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult intubated patients aged between 18 to 90 years
- Pass spontaneous breathing trial and receive the order to be extubated
- Have at least one of the indications to use HFNC after extubation
Key exclusion criteria (8 listed)
- Need to use inhaled epoprostenol via HFNC
- Pregnant
- Unable to use resuscitation mask, such as facial trauma, claustrophobia
- Non-English speaker
- Inability to verbally communicate
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 |
|---|---|---|
| HFNC flow set at patient peak tidal inspiratory flowHFNC flow will be set at the level equal to patient peak tidal inspiratory flow | Other | HFNC flow set at patient peak tidal inspiratory flow |
| HFNC flow set at 1.33 times of patient peak tidal inspiratory flowHFNC flow will be set at 1.33 times of patient peak tidal inspiratory flow | Other | HFNC flow set at 1.33 times of patient peak tidal inspiratory flow |
| HFNC flow set at 1.67 times of patient peak tidal inspiratory flowHFNC flow will be set at 1.67 times of patient peak tidal inspiratory flow | Other | HFNC flow set at 1.67 times of patient peak tidal inspiratory flow |
| HFNC flow set at 2 times of patient peak tidal inspiratory flowHFNC flow will be set 2 times of patient peak tidal inspiratory flow | Other | HFNC flow set at 2 times of patient peak tidal inspiratory flow |
Primary outcome
SpO2/FIO2
Time frame: 20 minutes after each flow setting
Twenty mins after each flow setting, pulse oximetry divided by fraction of inspired oxygen will be used to assess patient's oxygenation response to different flow
2 secondary outcomes
End-expiratory lung volume assessed by EIT
Time frame: 20 minutes after each flow setting
self-evaluated comfort
Time frame: 20 minutes after each flow setting
Results and safety
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 25981908Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
- Background: PubMed 30888444Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.
- Background: PubMed 27706464Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
- Background: PubMed 26975498Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
- Background: PubMed 33836812Yasuda H, Okano H, Mayumi T, Narita C, Onodera Y, Nakane M, Shime N. Post-extubation oxygenation strategies in acute respiratory failure: a systematic review and network meta-analysis. Crit Care. 2021 Apr 9;25(1):135. doi: 10.1186/s13054-021-03550-4.
- Background: PubMed 33621890Butt S, Pistidda L, Floris L, Liperi C, Vasques F, Glover G, Barrett NA, Sanderson B, Grasso S, Shankar-Hari M, Camporotaa L. Initial setting of high-flow nasal oxygen post extubation based on mean inspiratory flow during a spontaneous breathing trial. J Crit Care. 2021 Jun;63:40-44. doi: 10.1016/j.jcrc.2020.12.022. Epub 2020 Dec 27.
- Background: PubMed 31332551Mauri T, Spinelli E, Dalla Corte F, Scotti E, Turrini C, Lazzeri M, Alban L, Albanese M, Tortolani D, Wang YM, Spadaro S, Zhou JX, Pesenti A, Grasselli G. Noninvasive assessment of airflows by electrical impedance tomography in intubated hypoxemic patients: an exploratory study. Ann Intensive Care. 2019 Jul 22;9(1):83. doi: 10.1186/s13613-019-0560-5.
- 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.
- Results publication: PubMed 32213602Li J, Jing G, Scott JB. Year in Review 2019: High-Flow Nasal Cannula Oxygen Therapy for Adult Subjects. Respir Care. 2020 Apr;65(4):545-557. doi: 10.4187/respcare.07663.
- Results publication: PubMed 34837553Li J, Scott JB, Fink JB, Reed B, Roca O, Dhand R. Optimizing high-flow nasal cannula flow settings in adult hypoxemic patients based on peak inspiratory flow during tidal breathing. Ann Intensive Care. 2021 Nov 27;11(1):164. doi: 10.1186/s13613-021-00949-8.
- Individual participant dataSharing planned: Yes. De-identified patient data will be shared upon reasonable request 3 months after publication.
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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.
Jie Li, PhD principal investigator
Rush University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC flow set at patient peak tidal inspiratory flow, HFNC flow set at 1.33 times of patient peak tidal inspiratory flow and HFNC flow set at 1.67 times of patient peak tidal inspiratory flow in people with Hypoxemic Respiratory Failure, run by Rush University Medical Center at 2 sites in 2 countries.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
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?
SpO2/FIO2 (time frame: 20 minutes after each flow setting). 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 NCT04971148, which also lists 10 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 14 Aug 2023.