Respiratory Distress Syndrome, AdultGLAMOURNCT06489379
High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room
A study testing high flow nasal cannula and standard oxygen in people with Respiratory Distress Syndrome, Adult, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitted to the ER because of acute hypoxemic respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- high flow nasal cannula and standard oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2026
- 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
- Age ≥ 18 years;
- PaO2/FiO2 ratio between 250 and 150 mmHg or SpO2/FiO2 ratio between 190 and 274, after at least 15 minutes of spontaneous breathing through a Venturi mask (VM), with a FiO2 targeted at a SpO2 94-97%;
- Respiratory rate(RR)≤35breaths/min,afteratleast15minutesofspontaneous breathing through a VM, with a FiO2 targeted at a SpO2 94-97%;
- PaCO2 ≤ 45 mmHg;
- Unilateral or bilateral infiltrate(s), as detected with chest radiography and/or computed tomography and/or with lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses. Infiltrates at lung ultrasound are defined as presence of focal B-lines, consolidations (with irregular marginal contour, air bronchogram, air trapping sign) and irregularity of the pleural line.
Who cannot join
- Respiratory failure due to:
- Acute asthma or COPD exacerbation,
- Cardiac failure or fluid overload as primary cause of respiratory failure;
- Unstable angina or ongoing acute myocardial infarction;
- Acute respiratory acidosis with pH < 7.35 and PaCO2 > 45 mmHg;
- Hemodynamic instability and/or use of vasopressors/inotropes;
Show all 12Show fewer
- Altered mental status (Kelly >3), see Figure 1;(18)
- Contraindications to NIV (high risk of aspiration pneumonia, impaired airways protection, head-facial trauma and/or burns, uncooperative patient, cranial/thoracic/abdominal open wounds);
- Indications to urgent intubation performed according to the clinician in charge;
- Body Mass Index > 35 kg/m2;
- Pregnancy;
- Patient's refusal to participate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room: the GLAMOUR Study
The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitted to the ER because of acute hypoxemic respiratory failure.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- high flow nasal cannula, standard oxygen
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannulaDevice
humidified and heated oxygen
standard oxygenOther
oxygen delivery through Venturi mask
| Study group | Role | What they receive |
|---|---|---|
| standard oxygen | Active comparator | Not described Receives: Other: standard oxygen |
| high flow nasal oxygen | Experimental | Not described Receives: Device: high flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early deterioration
occurrence of any of the following from randomization: respiratory worsening; respiratory acidosis; severe respiratory distress; start of non-invasive ventilation; necessity of endotracheal intubation; development of shock; death.
Measured: 24 hours
Secondary outcomes (15)
Development of respiratory acidosis
arterial pH
Measured: 2, 12 and 24 hours
Development of hypercapnia
arterial pCO2
Measured: 2, 12 and 24 hours
Worsening hypoxemia
P/F ratio
Measured: 2, 12 and 24 hours
Worsening respiratory distress
respiratory frequency
Measured: 2, 12 and 24 hours
duration of any type of ventilatory support
hours of ventilatory support
Measured: 90 days
rate of ICU admission
number of patients admitted to ICU
Measured: 90 days
hospital length-of-stay
duration of hospitalization
Measured: 30 days
in-hospital mortality
death during hospitalization
Measured: 90 days
ICU length-of-stay
duration of ICU stay
Measured: 90 days
ICU mortality
death in ICU
Measured: 90 days
development of complications
composite outcome of septic shock, nosocomial pneumonia, cardiac arrhythmia, cardiac arrest, delirium
Measured: 90 days
level of dyspnea
utilizing Borg scale
Measured: 24 hours
patient comfort
utilizing visual analogue scale
Measured: 24 hours
clinical setting after ED stabilization
type of ward admission
Measured: 24 hours
standard vs asymmetrical high-flow nasal cannula
rate of early deterioration in the treatment group will be compared between patients treated with standard or asymmetrical high-flow nasal cannula
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FRANCESCHI FRANCESCO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489379
- Sponsor's protocol ID
- 6697
- Acronym
- GLAMOUR
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Raveling T, Vonk J, Struik FM, Goldstein R, Kerstjens HA, Wijkstra PJ, Duiverman ML. Chronic non-invasive ventilation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Aug 9;8(8):CD002878. doi: 10.1002/14651858.CD002878.pub3.
PubMed 34368950Berbenetz N, Wang Y, Brown J, Godfrey C, Ahmad M, Vital FM, Lambiase P, Banerjee A, Bakhai A, Chong M. Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary oedema. Cochrane Database Syst Rev. 2019 Apr 5;4(4):CD005351. doi: 10.1002/14651858.CD005351.pub4.
PubMed 30950507Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
PubMed 28860265Antonelli M, Conti G, Esquinas A, Montini L, Maggiore SM, Bello G, Rocco M, Maviglia R, Pennisi MA, Gonzalez-Diaz G, Meduri GU. A multiple-center survey on the use in clinical practice of noninvasive ventilation as a first-line intervention for acute respiratory distress syndrome. Crit Care Med. 2007 Jan;35(1):18-25. doi: 10.1097/01.CCM.0000251821.44259.F3.
PubMed 17133177Carteaux G, Millan-Guilarte T, De Prost N, Razazi K, Abid S, Thille AW, Schortgen F, Brochard L, Brun-Buisson C, Mekontso Dessap A. Failure of Noninvasive Ventilation for De Novo Acute Hypoxemic Respiratory Failure: Role of Tidal Volume. Crit Care Med. 2016 Feb;44(2):282-90. doi: 10.1097/CCM.0000000000001379.
PubMed 26584191Bellani G, Laffey JG, Pham T, Madotto F, Fan E, Brochard L, Esteban A, Gattinoni L, Bumbasirevic V, Piquilloud L, van Haren F, Larsson A, McAuley DF, Bauer PR, Arabi YM, Ranieri M, Antonelli M, Rubenfeld GD, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Noninvasive Ventilation of Patients with Acute Respiratory Distress Syndrome. Insights from the LUNG SAFE Study. Am J Respir Crit Care Med. 2017 Jan 1;195(1):67-77. doi: 10.1164/rccm.201606-1306OC.
PubMed 27753501Demoule A, Girou E, Richard JC, Taille S, Brochard L. Benefits and risks of success or failure of noninvasive ventilation. Intensive Care Med. 2006 Nov;32(11):1756-65. doi: 10.1007/s00134-006-0324-1. Epub 2006 Sep 21.
PubMed 17019559Marjanovic N, Guenezan J, Frat JP, Mimoz O, Thille AW. High-flow nasal cannula oxygen therapy in acute respiratory failure at Emergency Departments: A systematic review. Am J Emerg Med. 2020 Jul;38(7):1508-1514. doi: 10.1016/j.ajem.2020.04.091. Epub 2020 May 4.
PubMed 32389397Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.
PubMed 20406507Oczkowski S, Ergan B, Bos L, Chatwin M, Ferrer M, Gregoretti C, Heunks L, Frat JP, Longhini F, Nava S, Navalesi P, Ozsancak Ugurlu A, Pisani L, Renda T, Thille AW, Winck JC, Windisch W, Tonia T, Boyd J, Sotgiu G, Scala R. ERS clinical practice guidelines: high-flow nasal cannula in acute respiratory failure. Eur Respir J. 2022 Apr 14;59(4):2101574. doi: 10.1183/13993003.01574-2021. Print 2022 Apr.
PubMed 34649974Chidekel A, Zhu Y, Wang J, Mosko JJ, Rodriguez E, Shaffer TH. The effects of gas humidification with high-flow nasal cannula on cultured human airway epithelial cells. Pulm Med. 2012;2012:380686. doi: 10.1155/2012/380686. Epub 2012 Sep 3.
PubMed 22988501Frat 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 25981908Tinelli V, Cabrini L, Fominskiy E, Franchini S, Ferrante L, Ball L, Pelosi P, Landoni G, Zangrillo A, Secchi A. High Flow Nasal Cannula Oxygen vs. Conventional Oxygen Therapy and Noninvasive Ventilation in Emergency Department Patients: A Systematic Review and Meta-Analysis. J Emerg Med. 2019 Sep;57(3):322-328. doi: 10.1016/j.jemermed.2019.06.033. Epub 2019 Aug 14.
PubMed 31421952Rochwerg 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 30888444Matthay MA, Arabi Y, Arroliga AC, Bernard G, Bersten AD, Brochard LJ, Calfee CS, Combes A, Daniel BM, Ferguson ND, Gong MN, Gotts JE, Herridge MS, Laffey JG, Liu KD, Machado FR, Martin TR, McAuley DF, Mercat A, Moss M, Mularski RA, Pesenti A, Qiu H, Ramakrishnan N, Ranieri VM, Riviello ED, Rubin E, Slutsky AS, Thompson BT, Twagirumugabe T, Ware LB, Wick KD. A New Global Definition of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2024 Jan 1;209(1):37-47. doi: 10.1164/rccm.202303-0558WS.
PubMed 37487152
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room: the GLAMOUR Study
- ClinicalTrials.gov ID
- NCT06489379
- Acronym / sponsor ID
- GLAMOUR / 6697
- Conditions
- Respiratory Distress Syndrome, Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Jul 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.
The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitted to the ER because of acute hypoxemic respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard oxygen | Active comparator | Other: standard oxygen |
| high flow nasal oxygen | Experimental | Device: high flow nasal cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years;
- PaO2/FiO2 ratio between 250 and 150 mmHg or SpO2/FiO2 ratio between 190 and 274, after at least 15 minutes of spontaneous breathing through a Venturi mask (VM), with a FiO2 targeted at a SpO2 94-97%;
- Respiratory rate(RR)≤35breaths/min,afteratleast15minutesofspontaneous breathing through a VM, with a FiO2 targeted at a SpO2 94-97%;
- PaCO2 ≤ 45 mmHg;
- Unilateral or bilateral infiltrate(s), as detected with chest radiography and/or computed tomography and/or with lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses. Infiltrates at lung ultrasound are defined as presence of focal B-lines, consolidations (with irregular marginal contour, air bronchogram, air trapping sign) and irregularity of the pleural line.
Key exclusion criteria (12 listed)
- Respiratory failure due to:
- Unstable angina or ongoing acute myocardial infarction;
- Acute respiratory acidosis with pH < 7.35 and PaCO2 > 45 mmHg;
- Hemodynamic instability and/or use of vasopressors/inotropes;
- Altered mental status (Kelly >3), see Figure 1;(18)
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 cannulahumidified and heated oxygen | Device | high flow nasal oxygen |
| standard oxygenoxygen delivery through Venturi mask | Other | standard oxygen |
Primary outcome
Early deterioration
Time frame: 24 hours
occurrence of any of the following from randomization: respiratory worsening; respiratory acidosis; severe respiratory distress; start of non-invasive ventilation; necessity of endotracheal intubation; development of shock; death.
15 secondary outcomes
Development of respiratory acidosis
Time frame: 2, 12 and 24 hours
Development of hypercapnia
Time frame: 2, 12 and 24 hours
Worsening hypoxemia
Time frame: 2, 12 and 24 hours
Worsening respiratory distress
Time frame: 2, 12 and 24 hours
duration of any type of ventilatory support
Time frame: 90 days
rate of ICU admission
Time frame: 90 days
hospital length-of-stay
Time frame: 30 days
in-hospital mortality
Time frame: 90 days
ICU length-of-stay
Time frame: 90 days
ICU mortality
Time frame: 90 days
development of complications
Time frame: 90 days
level of dyspnea
Time frame: 24 hours
patient comfort
Time frame: 24 hours
clinical setting after ED stabilization
Time frame: 24 hours
standard vs asymmetrical high-flow nasal cannula
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Background: PubMed 34368950Raveling T, Vonk J, Struik FM, Goldstein R, Kerstjens HA, Wijkstra PJ, Duiverman ML. Chronic non-invasive ventilation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Aug 9;8(8):CD002878. doi: 10.1002/14651858.CD002878.pub3.
- Background: PubMed 30950507Berbenetz N, Wang Y, Brown J, Godfrey C, Ahmad M, Vital FM, Lambiase P, Banerjee A, Bakhai A, Chong M. Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary oedema. Cochrane Database Syst Rev. 2019 Apr 5;4(4):CD005351. doi: 10.1002/14651858.CD005351.pub4.
- Background: PubMed 28860265Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
- Background: PubMed 17133177Antonelli M, Conti G, Esquinas A, Montini L, Maggiore SM, Bello G, Rocco M, Maviglia R, Pennisi MA, Gonzalez-Diaz G, Meduri GU. A multiple-center survey on the use in clinical practice of noninvasive ventilation as a first-line intervention for acute respiratory distress syndrome. Crit Care Med. 2007 Jan;35(1):18-25. doi: 10.1097/01.CCM.0000251821.44259.F3.
- Background: PubMed 26584191Carteaux G, Millan-Guilarte T, De Prost N, Razazi K, Abid S, Thille AW, Schortgen F, Brochard L, Brun-Buisson C, Mekontso Dessap A. Failure of Noninvasive Ventilation for De Novo Acute Hypoxemic Respiratory Failure: Role of Tidal Volume. Crit Care Med. 2016 Feb;44(2):282-90. doi: 10.1097/CCM.0000000000001379.
- Background: PubMed 27753501Bellani G, Laffey JG, Pham T, Madotto F, Fan E, Brochard L, Esteban A, Gattinoni L, Bumbasirevic V, Piquilloud L, van Haren F, Larsson A, McAuley DF, Bauer PR, Arabi YM, Ranieri M, Antonelli M, Rubenfeld GD, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Noninvasive Ventilation of Patients with Acute Respiratory Distress Syndrome. Insights from the LUNG SAFE Study. Am J Respir Crit Care Med. 2017 Jan 1;195(1):67-77. doi: 10.1164/rccm.201606-1306OC.
- Background: PubMed 17019559Demoule A, Girou E, Richard JC, Taille S, Brochard L. Benefits and risks of success or failure of noninvasive ventilation. Intensive Care Med. 2006 Nov;32(11):1756-65. doi: 10.1007/s00134-006-0324-1. Epub 2006 Sep 21.
- Background: PubMed 32389397Marjanovic N, Guenezan J, Frat JP, Mimoz O, Thille AW. High-flow nasal cannula oxygen therapy in acute respiratory failure at Emergency Departments: A systematic review. Am J Emerg Med. 2020 Jul;38(7):1508-1514. doi: 10.1016/j.ajem.2020.04.091. Epub 2020 May 4.
- 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 34649974Oczkowski S, Ergan B, Bos L, Chatwin M, Ferrer M, Gregoretti C, Heunks L, Frat JP, Longhini F, Nava S, Navalesi P, Ozsancak Ugurlu A, Pisani L, Renda T, Thille AW, Winck JC, Windisch W, Tonia T, Boyd J, Sotgiu G, Scala R. ERS clinical practice guidelines: high-flow nasal cannula in acute respiratory failure. Eur Respir J. 2022 Apr 14;59(4):2101574. doi: 10.1183/13993003.01574-2021. Print 2022 Apr.
- Background: PubMed 22988501Chidekel A, Zhu Y, Wang J, Mosko JJ, Rodriguez E, Shaffer TH. The effects of gas humidification with high-flow nasal cannula on cultured human airway epithelial cells. Pulm Med. 2012;2012:380686. doi: 10.1155/2012/380686. Epub 2012 Sep 3.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal cannula and standard oxygen in people with Respiratory Distress Syndrome, Adult, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 5 inclusion and 12 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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Francesco Franceschi, MD (+390630156627, francesco.franceschi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early deterioration (time frame: 24 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 NCT06489379, which also lists 26 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 5 Jul 2024.