End-Expiratory Lung ImpedanceEELI and AHFNCNCT06674629
Asymmetrical High Flow Nasal Cannula and End-Expiratory Lung Impedance
An observational study of End-Expiratory Lung Impedance and Respiratory Rate, run by Argentinian Intensive Care Society at 1 site in Argentina.
Trial summary
Objective: The primary aim is to assess end-expiratory lung impedance (EELI) changes during the application of high-flow oxygen therapy using asymmetric nasal cannulae, comparing conditions with the mouth closed and open in healthy volunteers in various positions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- End-Expiratory Lung Impedance, Respiratory Rate, Diaphragm Thickness Fraction
- What is being tested?
- High flow oxygen therapy
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteArgentina
- Study dates
- 5 Nov 2024to 31 Jan 2025
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers healthcare professionals working at Sanatorio Parque in Rosario, aged between 18 and 50 years, who sign the informed consent form and have no history of respiratory pathology (who are non-smokers and do not have a history of any type of respiratory disease).
Who may be able to join
- healthy volunteers between 18 and 50 years of age who sign the informed consent form, without respiratory pathology.
Who cannot join
- contraindication to implement electrical impedance tomography or high flow oxygen therapy
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Británico de Buenos Aires
Buenos Aires, Buenos Aires, 1425
About this study
Official title: Effects of an Asymmetrical High Flow Nasal Cannula Interface on End-Expiratory Lung Impedance
Objective: The primary aim is to assess end-expiratory lung impedance (EELI) changes during the application of high-flow oxygen therapy using asymmetric nasal cannulae, comparing conditions with the mouth closed and open in healthy volunteers in various positions. The secondary objective includes evaluating respiratory rate, shortening fraction, and diaphragm excursion via ultrasound.
Study Design: This is a prospective observational cohort study conducted in the Critical Care Unit of Sanatorio Parque Rosario from November 5 to December 31, 2024. It will involve 20 healthy adult volunteers without respiratory conditions, with informed consent obtained from all participants. Volunteers with contraindications for electrical impedance tomography (EIT) will be excluded.
Read more
Methods: Equipment Used: PulmoVista 500 Dräger (EIT), AIRVO 2 (high-flow oxygen generator), asymmetric nasal cannula (Optiflow OPT 966), Toshiba iStyle ultrasound machine.
Procedures: The study includes EELI measurements in different positions (semi-seated, supine Fowler, prone, and prone Fowler) with various high-flow oxygen settings (40 and 60 L/min). Diaphragm excursion and thickening will be assessed using ultrasound.
Scenarios and Measurements: 17 different testing scenarios will be conducted, with 16 intervals for washout breathing at room air between scenarios. Data on EELI, respiratory rate, and diaphragm measurements will be collected.
Read the detailed description
Methodology:
Procedures: EELI, respiratory rate, and diaphragm measurements will be taken in various body positions while using high-flow oxygen therapy (HFNC) set at 40 and 60 L/min. Diaphragm excursion and thickening will be evaluated with ultrasound.
Data Collection and Analysis: Volunteers will participate in 17 different testing scenarios, with intervals of 5-minute washout periods breathing room air in a semi-seated position between each measurement. Continuous variables will be expressed as mean ± standard deviation or median and interquartile range. Repeated measures ANOVA will be used for statistical comparisons, with significance set at p < 0.05.
17 Testing Scenarios:
Semi-seated at 45° breathing room air. Semi-seated at 45° with asymmetric HFNC at 40 L/min, mouth closed for 5 minutes.
Semi-seated at 45° with asymmetric HFNC at 40 L/min, mouth open for 5 minutes. Semi-seated at 45° with asymmetric HFNC at 60 L/min, mouth closed for 5 minutes.
Semi-seated at 45° with asymmetric HFNC at 60 L/min, mouth open for 5 minutes. Supine in Fowler position (60°) with asymmetric HFNC at 40 L/min, mouth open for 5 minutes.
Supine in Fowler position (60°) with asymmetric HFNC at 40 L/min, mouth closed for 5 minutes.
Supine in Fowler position (60°) with asymmetric HFNC at 60 L/min, mouth open for 5 minutes.
Supine in Fowler position (60°) with asymmetric HFNC at 60 L/min, mouth closed for 5 minutes.
Prone at 180° with asymmetric HFNC at 40 L/min, mouth open for 5 minutes. Prone at 180° with asymmetric HFNC at 40 L/min, mouth closed for 5 minutes. Prone at 180° with asymmetric HFNC at 60 L/min, mouth open for 5 minutes. Prone at 180° with asymmetric HFNC at 60 L/min, mouth closed for 5 minutes. Prone Fowler position with asymmetric HFNC at 40 L/min, mouth open for 5 minutes.
Prone Fowler position with asymmetric HFNC at 40 L/min, mouth closed for 5 minutes.
Prone Fowler position with asymmetric HFNC at 60 L/min, mouth open for 5 minutes.
Prone Fowler position with asymmetric HFNC at 60 L/min, mouth closed for 5 minutes.
Duration per Participant: Approximately 2 hours and 15 minutes.
Ethical Considerations: All data will be anonymized and kept confidential. Participants' rights to withdraw at any time will be respected, and no personal identifying information will be disclosed.
This comprehensive approach aims to elucidate the physiological impacts of using asymmetric HFOT on end-expiratory lung volume and related respiratory parameters in various positions and conditions.
- Conditions
- End-Expiratory Lung Impedance, Respiratory Rate, Diaphragm Thickness Fraction, Diaphragm Excursion
- Being tested
- High flow oxygen therapy
- Keywords
- High Flow Oxygen Therapy, End-Expiratory Lung Impedance, Respiratory rate, Diaphragm Thickness Fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow oxygen therapyDevice
Application of high flow oxygen therapy through asymmetric cannula at 40 and 60 L/m
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Volunteers | Healthy adult volunteers, all above 18 years of age, who provide informed consent. Receives: Device: High flow oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-Expiratory Lung Impedance
Variation of end-expiratory lung impedance in different positions and with different flows.
Measured: From enrollment to the end of treatment at 2.30hours
Secondary outcomes (3)
Respiratory Rate
Number of respiratory cycles per minute while breathing in a quiet manner at rest.
Measured: From enrollment to the end of treatment at 2.30hours
Diaphragm Thickness Fraction
Diaphragm Thickness Fraction (DTF) is a measure used to assess diaphragm function by comparing the change in diaphragm thickness from end-expiration to end-inspiration expressed as a percentage
Measured: From enrollment to the end of treatment at 2.30hours
Diaphragm excursion
Diaphragm excursion refers to the movement or displacement of the diaphragm during the respiratory cycle, measured from its lowest position at end-expiration to its highest position at end-inspiration. This parameter is assessed using ultrasound and reflects the diaphragm's ability to contract effectively, with greater excursion indicating stronger respiratory muscle function.
Measured: From enrollment to the end of treatment at 2.30hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start5 Nov 2024
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
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 End-Expiratory Lung ImpedanceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argentinian Intensive Care Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Plotnikow, Argentinian Intensive Care Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674629
- Sponsor's protocol ID
- #30102024
- Acronym
- EELI and AHFNC
- Status last verified
- Jun 2025
- First submitted
- 4 Nov 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD on which the results of the publication are based will be in the publication or shared through direct links after consultation with the PI via e-mail
Publications
Slobod D, Spinelli E, Crotti S, Lissoni A, Galazzi A, Grasselli G, Mauri T. Effects of an asymmetrical high flow nasal cannula interface in hypoxemic patients. Crit Care. 2023 Apr 18;27(1):145. doi: 10.1186/s13054-023-04441-6.
PubMed 37072854Boscolo A, Pettenuzzo T, Zarantonello F, Sella N, Pistollato E, De Cassai A, Congedi S, Paiusco I, Bertoldo G, Crociani S, Toma F, Mormando G, Lorenzoni G, Gregori D, Navalesi P. Asymmetrical high-flow nasal cannula performs similarly to standard interface in patients with acute hypoxemic post-extubation respiratory failure: a pilot study. BMC Pulm Med. 2024 Jan 8;24(1):21. doi: 10.1186/s12890-023-02820-x.
PubMed 38191347Tatkov S, Rees M, Gulley A, van den Heuij LGT, Nilius G. Asymmetrical nasal high flow ventilation improves clearance of CO2 from the anatomical dead space and increases positive airway pressure. J Appl Physiol (1985). 2023 Feb 1;134(2):365-377. doi: 10.1152/japplphysiol.00692.2022. Epub 2023 Jan 12.
PubMed 36633864Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.
PubMed 20406507Parke RL, Eccleston ML, McGuinness SP. The effects of flow on airway pressure during nasal high-flow oxygen therapy. Respir Care. 2011 Aug;56(8):1151-5. doi: 10.4187/respcare.01106. Epub 2011 Apr 15.
PubMed 21496369Groves N, Tobin A. High flow nasal oxygen generates positive airway pressure in adult volunteers. Aust Crit Care. 2007 Nov;20(4):126-31. doi: 10.1016/j.aucc.2007.08.001. Epub 2007 Oct 10.
PubMed 17931878Plotnikow GA, Thille AW, Vasquez DN, Pratto RA, Quiroga CM, Andrich ME, Dorado JH, Gomez RS, D'Annunzio PA, Scapellato JL, Intile D. Effects of High-Flow Nasal Cannula on End-Expiratory Lung Impedance in Semi-Seated Healthy Subjects. Respir Care. 2018 Aug;63(8):1016-1023. doi: 10.4187/respcare.06031. Epub 2018 Jun 26.
PubMed 29945910Hernandez 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 26975498Frat 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 25981908Roca O, Hernandez G, Diaz-Lobato S, Carratala JM, Gutierrez RM, Masclans JR; Spanish Multidisciplinary Group of High Flow Supportive Therapy in Adults (HiSpaFlow). Current evidence for the effectiveness of heated and humidified high flow nasal cannula supportive therapy in adult patients with respiratory failure. Crit Care. 2016 Apr 28;20(1):109. doi: 10.1186/s13054-016-1263-z.
PubMed 27121707
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Asymmetrical High Flow Nasal Cannula Interface on End-Expiratory Lung Impedance
- ClinicalTrials.gov ID
- NCT06674629
- Acronym / sponsor ID
- EELI and AHFNC / #30102024
- Conditions
- End-Expiratory Lung Impedance, Respiratory Rate, Diaphragm Thickness Fraction, Diaphragm Excursion
- Keywords
- High Flow Oxygen Therapy, End-Expiratory Lung Impedance, Respiratory rate, Diaphragm Thickness Fraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Argentinian Intensive Care SocietyUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 5 Nov 2024 (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.
Objective: The primary aim is to assess end-expiratory lung impedance (EELI) changes during the application of high-flow oxygen therapy using asymmetric nasal cannulae, comparing conditions with the mouth closed and open in healthy volunteers in various positions. The secondary objective includes evaluating respiratory rate, shortening fraction, and diaphragm excursion via ultrasound.
Study Design: This is a prospective observational cohort study conducted in the Critical Care Unit of Sanatorio Parque Rosario from November 5 to December 31, 2024. It will involve 20 healthy adult volunteers without respiratory conditions, with informed consent obtained from all participants. Volunteers with contraindications for electrical impedance tomography (EIT) will be excluded.
Methods: Equipment Used: PulmoVista 500 Dräger (EIT), AIRVO 2 (high-flow oxygen generator), asymmetric nasal cannula (Optiflow OPT 966), Toshiba iStyle ultrasound machine.
Procedures: The study includes EELI measurements in different positions (semi-seated, supine Fowler, prone, and prone Fowler) with various high-flow oxygen settings (40 and 60 L/min). Diaphragm excursion and thickening will be assessed using ultrasound.
Scenarios and Measurements: 17 different testing scenarios will be conducted, with 16 intervals for washout breathing at room air between scenarios. Data on EELI, respiratory rate, and diaphragm measurements will be collected.
Detailed description
Methodology:
Procedures: EELI, respiratory rate, and diaphragm measurements will be taken in various body positions while using high-flow oxygen therapy (HFNC) set at 40 and 60 L/min. Diaphragm excursion and thickening will be evaluated with ultrasound.
Data Collection and Analysis: Volunteers will participate in 17 different testing scenarios, with intervals of 5-minute washout periods breathing room air in a semi-seated position between each measurement. Continuous variables will be expressed as mean ± standard deviation or median and interquartile range. Repeated measures ANOVA will be used for statistical comparisons, with significance set at p < 0.05.
17 Testing Scenarios:
Semi-seated at 45° breathing room air. Semi-seated at 45° with asymmetric HFNC at 40 L/min, mouth closed for 5 minutes.
Semi-seated at 45° with asymmetric HFNC at 40 L/min, mouth open for 5 minutes. Semi-seated at 45° with asymmetric HFNC at 60 L/min, mouth closed for 5 minutes.
Semi-seated at 45° with asymmetric HFNC at 60 L/min, mouth open for 5 minutes. Supine in Fowler position (60°) with asymmetric HFNC at 40 L/min, mouth open for 5 minutes.
Supine in Fowler position (60°) with asymmetric HFNC at 40 L/min, mouth closed for 5 minutes.
Supine in Fowler position (60°) with asymmetric HFNC at 60 L/min, mouth open for 5 minutes.
Supine in Fowler position (60°) with asymmetric HFNC at 60 L/min, mouth closed for 5 minutes.
Prone at 180° with asymmetric HFNC at 40 L/min, mouth open for 5 minutes. Prone at 180° with asymmetric HFNC at 40 L/min, mouth closed for 5 minutes. Prone at 180° with asymmetric HFNC at 60 L/min, mouth open for 5 minutes. Prone at 180° with asymmetric HFNC at 60 L/min, mouth closed for 5 minutes. Prone Fowler position with asymmetric HFNC at 40 L/min, mouth open for 5 minutes.
Prone Fowler position with asymmetric HFNC at 40 L/min, mouth closed for 5 minutes.
Prone Fowler position with asymmetric HFNC at 60 L/min, mouth open for 5 minutes.
Prone Fowler position with asymmetric HFNC at 60 L/min, mouth closed for 5 minutes.
Duration per Participant: Approximately 2 hours and 15 minutes.
Ethical Considerations: All data will be anonymized and kept confidential. Participants' rights to withdraw at any time will be respected, and no personal identifying information will be disclosed.
This comprehensive approach aims to elucidate the physiological impacts of using asymmetric HFOT on end-expiratory lung volume and related respiratory parameters in various positions and conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Volunteers | – | Device: High flow oxygen therapyHealthy adult volunteers, all above 18 years of age, who provide informed consent. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers healthcare professionals working at Sanatorio Parque in Rosario, aged between 18 and 50 years, who sign the informed consent form and have no history of respiratory pathology (who are non-smokers and do not have a history of any type of respiratory disease).
Key inclusion criteria (1 listed)
- healthy volunteers between 18 and 50 years of age who sign the informed consent form, without respiratory pathology.
Key exclusion criteria (1 listed)
- contraindication to implement electrical impedance tomography or high flow oxygen therapy
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 oxygen therapyApplication of high flow oxygen therapy through asymmetric cannula at 40 and 60 L/m | Device | Healthy Adult Volunteers |
Primary outcome
End-Expiratory Lung Impedance
Time frame: From enrollment to the end of treatment at 2.30hours
Variation of end-expiratory lung impedance in different positions and with different flows.
3 secondary outcomes
Respiratory Rate
Time frame: From enrollment to the end of treatment at 2.30hours
Diaphragm Thickness Fraction
Time frame: From enrollment to the end of treatment at 2.30hours
Diaphragm excursion
Time frame: From enrollment to the end of treatment at 2.30hours
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 2 Jul 2025.
- Background: PubMed 37072854Slobod D, Spinelli E, Crotti S, Lissoni A, Galazzi A, Grasselli G, Mauri T. Effects of an asymmetrical high flow nasal cannula interface in hypoxemic patients. Crit Care. 2023 Apr 18;27(1):145. doi: 10.1186/s13054-023-04441-6.
- Background: PubMed 38191347Boscolo A, Pettenuzzo T, Zarantonello F, Sella N, Pistollato E, De Cassai A, Congedi S, Paiusco I, Bertoldo G, Crociani S, Toma F, Mormando G, Lorenzoni G, Gregori D, Navalesi P. Asymmetrical high-flow nasal cannula performs similarly to standard interface in patients with acute hypoxemic post-extubation respiratory failure: a pilot study. BMC Pulm Med. 2024 Jan 8;24(1):21. doi: 10.1186/s12890-023-02820-x.
- Background: PubMed 36633864Tatkov S, Rees M, Gulley A, van den Heuij LGT, Nilius G. Asymmetrical nasal high flow ventilation improves clearance of CO2 from the anatomical dead space and increases positive airway pressure. J Appl Physiol (1985). 2023 Feb 1;134(2):365-377. doi: 10.1152/japplphysiol.00692.2022. Epub 2023 Jan 12.
- Background: PubMed 20406507Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.
- Background: PubMed 21496369Parke RL, Eccleston ML, McGuinness SP. The effects of flow on airway pressure during nasal high-flow oxygen therapy. Respir Care. 2011 Aug;56(8):1151-5. doi: 10.4187/respcare.01106. Epub 2011 Apr 15.
- Background: PubMed 17931878Groves N, Tobin A. High flow nasal oxygen generates positive airway pressure in adult volunteers. Aust Crit Care. 2007 Nov;20(4):126-31. doi: 10.1016/j.aucc.2007.08.001. Epub 2007 Oct 10.
- Background: PubMed 29945910Plotnikow GA, Thille AW, Vasquez DN, Pratto RA, Quiroga CM, Andrich ME, Dorado JH, Gomez RS, D'Annunzio PA, Scapellato JL, Intile D. Effects of High-Flow Nasal Cannula on End-Expiratory Lung Impedance in Semi-Seated Healthy Subjects. Respir Care. 2018 Aug;63(8):1016-1023. doi: 10.4187/respcare.06031. Epub 2018 Jun 26.
- 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 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 27121707Roca O, Hernandez G, Diaz-Lobato S, Carratala JM, Gutierrez RM, Masclans JR; Spanish Multidisciplinary Group of High Flow Supportive Therapy in Adults (HiSpaFlow). Current evidence for the effectiveness of heated and humidified high flow nasal cannula supportive therapy in adult patients with respiratory failure. Crit Care. 2016 Apr 28;20(1):109. doi: 10.1186/s13054-016-1263-z.
- Drive Study linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD on which the results of the publication are based will be in the publication or shared through direct links after consultation with the PI via e-mail
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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.
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?
An observational study of End-Expiratory Lung Impedance and Respiratory Rate, run by Argentinian Intensive Care Society at 1 site in Argentina.
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 2 Jul 2025. 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 Argentina. 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?
End-Expiratory Lung Impedance (time frame: From enrollment to the end of treatment at 2.30hours). 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 NCT06674629, 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 2 Jul 2025.