Acute Respiratory Distress SyndromeFRAIL ARDSNCT05816954
Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS
An observational study of Acute Respiratory Distress Syndrome and Barotrauma, run by Università Vita-Salute San Raffaele at 2 sites in Italy.
Trial summary
The high incidence of barotrauma in patients with COVID-19-related acute respiratory distress syndrome (ARDS) (16.1%, with a mortality rate >60%) provides rationale for considering COVID-19 ARDS a paradigm for lung frailty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Barotrauma
- What is being tested?
- Chest Computed Tomography Scan per normal clinical practice
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Aug 2023to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with ARDS clinical suspicion or diagnosis will be enrolled; specifically, these patients will be admitted at intensive care unit. All patients enrolled in the prospective cohort will follow their normal course of diagnosis/treatment without any further requirements for the scope of this study other than those provided in the normal management of patients with this condition. Furthermore, any decision regarding drug or procedure will be made by the physician based on her/his clinical judgment in the context of clinical practice, independently from the decision to include the patient in this study. No follow-up medical and/or imaging examinations/laboratory analysis after hospital discharge are needed by the present study design.
Who may be able to join
- Clinical and radiological signs of ARDS, according to Berlin criteria [14], requiring ICU admission;
- Obtain duly signed informed consent.
Who cannot join
- Poor quality imaging (because of motion/respiratory artefacts).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Mater Domini
Catanzaro, Calabria
Federico Longhini, MD
- Recruiting
IRCCS San Raffaele Scientific Institute
Milan, MI, 20132
Diego Palumbo, MD
About this study
Official title: Artificial Intelligence-based Identification of Imaging Biomarkers of Lung FRAILty in Patients With Acute Respiratory Distress Syndrome.
The high incidence of barotrauma in patients with COVID-19-related acute respiratory distress syndrome (ARDS) (16.1%, with a mortality rate >60%) provides rationale for considering COVID-19 ARDS a paradigm for lung frailty. The investigators recently discovered that the Macklin effect is an impressive radiological predictor of barotrauma in COVID-19 ARDS. Since lung frailty is a major issue also in non-COVID-19 ARDS (6% barotrauma, with a mortality rate of 46% ) the investigators want to confirm the importance of Macklin effect in non-COVID-19 ARDS. Using artificial intelligence-based approaches the investigators also want to identify imaging biomarkers to non-invasively assess lung frailty in a mixed cohort of COVID-19/non-COVID-19 ARDS patients. Furthermore, the investigators want to prospectively validate these biomarkers in a cohort of ARDS patients. This will provide a therapeutic algorithm for ARDS patients at high-risk for barotrauma, identifying those most likely to benefit from hyper protective strategies.
Read the detailed description
Development of barotrauma, spanning from asymptomatic air leakage within lung parenchyma to life-threatening conditions such as tension pneumothorax, is frequent in acute respiratory distress syndrome (ARDS), with a difficult, non-standardized management, resulting in high mortality rates (greater than 60% in coronavirus disease 2019 [COVID-19] ARDS patients, around 46% in non-COVID-19 ARDS patients). Of note, barotrauma occurs also in spontaneously breathing patients with COVID-19 ARDS. Frailty of lung parenchyma represents indeed a major issue in ARDS. In addition, in high-risk patients, mechanical ventilation may exacerbate pulmonary damage (ventilator-induced lung injury) and potentially induce barotrauma despite use of protective mechanical ventilation. Early assessment of lung frailty could therefore allows early risk stratification in terms of barotrauma susceptibility amongst ARDS patients, providing rationale for the deployment of lung protective management strategies in those at high-risk for barotrauma. Macklin effect, firstly intended to allow proper differentiation between respiratory and other causes of air leakage in the mediastinum (such as tracheobronchial/oesophageal injury), has been recently proved by our group to be a consistent, very accurate radiological predictor of barotrauma development in COVID-19 ARDS patients (sensitivity: 89.2%; specificity: 95.6%), anticipating by 12 days the occurrence of clinically overt barotrauma. These results have been confirmed, and even improved by multicentre findings, which report, on a large cohort of COVID-19 patients (almost 700), an impressive, almost perfect overall accuracy (99.8%) of the Macklin effect in predicting barotrauma development. Furthermore, data from our group suggest that early application of awake veno/venous extracorporeal membrane oxygenation (ECMO) without invasive mechanical ventilation in COVID-19 severe ARDS patients at high-risk for barotrauma (those with Macklin effect on chest CT imaging) is feasible and may result in no barotrauma events and low intubation rate. In this respect, confirmation of Macklin effect role and identification of further, novel quantitative imaging biomarkers could unveil biological bases of lung frailty in course of ARDS and provide instruments for early risk stratification before barotrauma occurrence.
Our group also implemented original in-house facilities consisting of densitometry, machine learning and artificial intelligence-based approaches to assess lung composition in COVID-19 patients throughout a fully automated workflow; recently, the investigators highlighted the outstanding clinical significance of this methodological approach in predicting patients' prognosis, as well as its great reproducibility. Preliminary, yet unpublished findings suggest that lung frailty has a specific densitometric signature, being a possible marker for hyper protective management strategies; few, highly robust radiomic features seem to corroborate the same result.
Accordingly, the driving hypotheses of this retrospective/prospective study are that, irrespective of COVID-19 status, in ARDS patients, i) lung frailty has a specific pattern of imaging biomarkers, and that ii) a more accurate selection of patients could limit the problem of barotrauma associated with mechanical ventilation.
- Conditions
- Acute Respiratory Distress Syndrome, Barotrauma
- Being tested
- Chest Computed Tomography Scan per normal clinical practice
- Medical subject headings
- Respiratory Distress Syndrome, Barotrauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Computed Tomography Scan per normal clinical practiceDiagnostic test
Normal Clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinically relevant barotrauma
Barotrauma is diagnosed only in the case of clear radiological evidence (free air at chest X-ray and/or chest CT scan).
When a "central" (non-alveolar) cause of barotrauma (tracheal fissure, esophageal rupture) is suspected, endoscopy will be performed.
Patients with barotrauma occurring within twelve hours from a chest interventional procedure (e.g. drains placement, central venous catheters insertion) will be excluded.
Measured: 30 days or until hospital discharge. Specifically, from date of basal CT scan until the date of first radiologically documented barotrauma.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start30 Aug 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Landoni, Università Vita-Salute San Raffaele
- Investigators
- Giovanni Landoni, Professor, Study chair, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816954
- Sponsor's protocol ID
- FRAIL ARDS - 49/INT/2022
- Acronym
- FRAIL ARDS
- Status last verified
- Aug 2025
- First submitted
- 23 Mar 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Belletti A, Todaro G, Valsecchi G, Losiggio R, Palumbo D, Landoni G, Zangrillo A. Barotrauma in Coronavirus Disease 2019 Patients Undergoing Invasive Mechanical Ventilation: A Systematic Literature Review. Crit Care Med. 2022 Mar 1;50(3):491-500. doi: 10.1097/CCM.0000000000005283.
PubMed 34637421Palumbo D, Campochiaro C, Belletti A, Marinosci A, Dagna L, Zangrillo A, De Cobelli F; COVID-BioB Study Group. Pneumothorax/pneumomediastinum in non-intubated COVID-19 patients: Differences between first and second Italian pandemic wave. Eur J Intern Med. 2021 Jun;88:144-146. doi: 10.1016/j.ejim.2021.03.018. Epub 2021 Mar 19. No abstract available.
PubMed 33820685Sakai M, Murayama S, Gibo M, Akamine T, Nagata O. Frequent cause of the Macklin effect in spontaneous pneumomediastinum: demonstration by multidetector-row computed tomography. J Comput Assist Tomogr. 2006 Jan-Feb;30(1):92-4. doi: 10.1097/01.rct.0000187416.07698.8d.
PubMed 16365580Murayama S, Gibo S. Spontaneous pneumomediastinum and Macklin effect: Overview and appearance on computed tomography. World J Radiol. 2014 Nov 28;6(11):850-4. doi: 10.4329/wjr.v6.i11.850.
PubMed 25431639Russell DW, Watts JR Jr, Powers TA. Searching for the Source of the Leak: PIE and the Macklin Effect. Ann Am Thorac Soc. 2018 Nov;15(11):1354-1356. doi: 10.1513/AnnalsATS.201803-200CC. No abstract available.
PubMed 30382777Belletti A, Palumbo D, Zangrillo A, Fominskiy EV, Franchini S, Dell'Acqua A, Marinosci A, Monti G, Vitali G, Colombo S, Guazzarotti G, Lembo R, Maimeri N, Faustini C, Pennella R, Mushtaq J, Landoni G, Scandroglio AM, Dagna L, De Cobelli F; COVID-BioB Study Group. Predictors of Pneumothorax/Pneumomediastinum in Mechanically Ventilated COVID-19 Patients. J Cardiothorac Vasc Anesth. 2021 Dec;35(12):3642-3651. doi: 10.1053/j.jvca.2021.02.008. Epub 2021 Feb 6.
PubMed 33678544Palumbo D, Zangrillo A, Belletti A, Guazzarotti G, Calvi MR, Guzzo F, Pennella R, Monti G, Gritti C, Marmiere M, Rocchi M, Colombo S, Valsecchi D, Scandroglio AM, Dagna L, Rovere-Querini P, Tresoldi M, Landoni G, De Cobelli F; COVID-BioB Study Group. A radiological predictor for pneumomediastinum/pneumothorax in COVID-19 ARDS patients. J Crit Care. 2021 Dec;66:14-19. doi: 10.1016/j.jcrc.2021.07.022. Epub 2021 Aug 12.
PubMed 34392131Paternoster G, Belmonte G, Scarano E, Rotondo P, Palumbo D, Belletti A, Corradi F, Bertini P, Landoni G, Guarracino F; COVID-Macklin Study Group. Macklin effect on baseline chest CT scan accurately predicts barotrauma in COVID-19 patients. Respir Med. 2022 Jun;197:106853. doi: 10.1016/j.rmed.2022.106853. Epub 2022 Apr 20.
PubMed 35512457Paternoster G, Bertini P, Belletti A, Landoni G, Gallotta S, Palumbo D, Isirdi A, Guarracino F. Venovenous Extracorporeal Membrane Oxygenation in Awake Non-Intubated Patients With COVID-19 ARDS at High Risk for Barotrauma. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):2975-2982. doi: 10.1053/j.jvca.2022.03.011. Epub 2022 Mar 17.
PubMed 35537972Mori M, Palumbo D, De Lorenzo R, Broggi S, Compagnone N, Guazzarotti G, Giorgio Esposito P, Mazzilli A, Steidler S, Pietro Vitali G, Del Vecchio A, Rovere Querini P, De Cobelli F, Fiorino C. Robust prediction of mortality of COVID-19 patients based on quantitative, operator-independent, lung CT densitometry. Phys Med. 2021 May;85:63-71. doi: 10.1016/j.ejmp.2021.04.022. Epub 2021 Apr 30.
PubMed 33971530Mori M, Alborghetti L, Palumbo D, Broggi S, Raspanti D, Rovere Querini P, Del Vecchio A, De Cobelli F, Fiorino C. Atlas-based lung segmentation combined with automatic densitometry characterization in COVID-19 patients: Training, validation and first application in a longitudinal study. Phys Med. 2022 Aug;100:142-152. doi: 10.1016/j.ejmp.2022.06.018. Epub 2022 Jul 4.
PubMed 35839667Palumbo D, Mori M, Prato F, Crippa S, Belfiori G, Reni M, Mushtaq J, Aleotti F, Guazzarotti G, Cao R, Steidler S, Tamburrino D, Spezi E, Del Vecchio A, Cascinu S, Falconi M, Fiorino C, De Cobelli F. Prediction of Early Distant Recurrence in Upfront Resectable Pancreatic Adenocarcinoma: A Multidisciplinary, Machine Learning-Based Approach. Cancers (Basel). 2021 Sep 30;13(19):4938. doi: 10.3390/cancers13194938.
PubMed 34638421ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-based Identification of Imaging Biomarkers of Lung FRAILty in Patients With Acute Respiratory Distress Syndrome.
- ClinicalTrials.gov ID
- NCT05816954
- Acronym / sponsor ID
- FRAIL ARDS / FRAIL ARDS - 49/INT/2022
- Conditions
- Acute Respiratory Distress Syndrome, Barotrauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Apr 2023 (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 high incidence of barotrauma in patients with COVID-19-related acute respiratory distress syndrome (ARDS) (16.1%, with a mortality rate >60%) provides rationale for considering COVID-19 ARDS a paradigm for lung frailty. The investigators recently discovered that the Macklin effect is an impressive radiological predictor of barotrauma in COVID-19 ARDS. Since lung frailty is a major issue also in non-COVID-19 ARDS (6% barotrauma, with a mortality rate of 46% ) the investigators want to confirm the importance of Macklin effect in non-COVID-19 ARDS. Using artificial intelligence-based approaches the investigators also want to identify imaging biomarkers to non-invasively assess lung frailty in a mixed cohort of COVID-19/non-COVID-19 ARDS patients. Furthermore, the investigators want to prospectively validate these biomarkers in a cohort of ARDS patients. This will provide a therapeutic algorithm for ARDS patients at high-risk for barotrauma, identifying those most likely to benefit from hyper protective strategies.
Detailed description
Development of barotrauma, spanning from asymptomatic air leakage within lung parenchyma to life-threatening conditions such as tension pneumothorax, is frequent in acute respiratory distress syndrome (ARDS), with a difficult, non-standardized management, resulting in high mortality rates (greater than 60% in coronavirus disease 2019 [COVID-19] ARDS patients, around 46% in non-COVID-19 ARDS patients). Of note, barotrauma occurs also in spontaneously breathing patients with COVID-19 ARDS. Frailty of lung parenchyma represents indeed a major issue in ARDS. In addition, in high-risk patients, mechanical ventilation may exacerbate pulmonary damage (ventilator-induced lung injury) and potentially induce barotrauma despite use of protective mechanical ventilation. Early assessment of lung frailty could therefore allows early risk stratification in terms of barotrauma susceptibility amongst ARDS patients, providing rationale for the deployment of lung protective management strategies in those at high-risk for barotrauma. Macklin effect, firstly intended to allow proper differentiation between respiratory and other causes of air leakage in the mediastinum (such as tracheobronchial/oesophageal injury), has been recently proved by our group to be a consistent, very accurate radiological predictor of barotrauma development in COVID-19 ARDS patients (sensitivity: 89.2%; specificity: 95.6%), anticipating by 12 days the occurrence of clinically overt barotrauma. These results have been confirmed, and even improved by multicentre findings, which report, on a large cohort of COVID-19 patients (almost 700), an impressive, almost perfect overall accuracy (99.8%) of the Macklin effect in predicting barotrauma development. Furthermore, data from our group suggest that early application of awake veno/venous extracorporeal membrane oxygenation (ECMO) without invasive mechanical ventilation in COVID-19 severe ARDS patients at high-risk for barotrauma (those with Macklin effect on chest CT imaging) is feasible and may result in no barotrauma events and low intubation rate. In this respect, confirmation of Macklin effect role and identification of further, novel quantitative imaging biomarkers could unveil biological bases of lung frailty in course of ARDS and provide instruments for early risk stratification before barotrauma occurrence.
Our group also implemented original in-house facilities consisting of densitometry, machine learning and artificial intelligence-based approaches to assess lung composition in COVID-19 patients throughout a fully automated workflow; recently, the investigators highlighted the outstanding clinical significance of this methodological approach in predicting patients' prognosis, as well as its great reproducibility. Preliminary, yet unpublished findings suggest that lung frailty has a specific densitometric signature, being a possible marker for hyper protective management strategies; few, highly robust radiomic features seem to corroborate the same result.
Accordingly, the driving hypotheses of this retrospective/prospective study are that, irrespective of COVID-19 status, in ARDS patients, i) lung frailty has a specific pattern of imaging biomarkers, and that ii) a more accurate selection of patients could limit the problem of barotrauma associated with mechanical ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ARDS clinical suspicion or diagnosis will be enrolled; specifically, these patients will be admitted at intensive care unit. All patients enrolled in the prospective cohort will follow their normal course of diagnosis/treatment without any further requirements for the scope of this study other than those provided in the normal management of patients with this condition. Furthermore, any decision regarding drug or procedure will be made by the physician based on her/his clinical judgment in the context of clinical practice, independently from the decision to include the patient in this study. No follow-up medical and/or imaging examinations/laboratory analysis after hospital discharge are needed by the present study design.
Key inclusion criteria (2 listed)
- Clinical and radiological signs of ARDS, according to Berlin criteria [14], requiring ICU admission;
- Obtain duly signed informed consent.
Key exclusion criteria (1 listed)
- Poor quality imaging (because of motion/respiratory artefacts).
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 |
|---|---|---|
| Chest Computed Tomography Scan per normal clinical practiceNormal Clinical practice | Diagnostic test | – |
Primary outcome
Rate of clinically relevant barotrauma
Time frame: 30 days or until hospital discharge. Specifically, from date of basal CT scan until the date of first radiologically documented barotrauma.
Barotrauma is diagnosed only in the case of clear radiological evidence (free air at chest X-ray and/or chest CT scan). When a "central" (non-alveolar) cause of barotrauma (tracheal fissure, esophageal rupture) is suspected, endoscopy will be performed. Patients with barotrauma occurring within twelve hours from a chest interventional procedure (e.g. drains placement, central venous catheters insertion) will be excluded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Background: PubMed 34637421Belletti A, Todaro G, Valsecchi G, Losiggio R, Palumbo D, Landoni G, Zangrillo A. Barotrauma in Coronavirus Disease 2019 Patients Undergoing Invasive Mechanical Ventilation: A Systematic Literature Review. Crit Care Med. 2022 Mar 1;50(3):491-500. doi: 10.1097/CCM.0000000000005283.
- Background: PubMed 33820685Palumbo D, Campochiaro C, Belletti A, Marinosci A, Dagna L, Zangrillo A, De Cobelli F; COVID-BioB Study Group. Pneumothorax/pneumomediastinum in non-intubated COVID-19 patients: Differences between first and second Italian pandemic wave. Eur J Intern Med. 2021 Jun;88:144-146. doi: 10.1016/j.ejim.2021.03.018. Epub 2021 Mar 19. No abstract available.
- Background: PubMed 16365580Sakai M, Murayama S, Gibo M, Akamine T, Nagata O. Frequent cause of the Macklin effect in spontaneous pneumomediastinum: demonstration by multidetector-row computed tomography. J Comput Assist Tomogr. 2006 Jan-Feb;30(1):92-4. doi: 10.1097/01.rct.0000187416.07698.8d.
- Background: PubMed 25431639Murayama S, Gibo S. Spontaneous pneumomediastinum and Macklin effect: Overview and appearance on computed tomography. World J Radiol. 2014 Nov 28;6(11):850-4. doi: 10.4329/wjr.v6.i11.850.
- Background: PubMed 30382777Russell DW, Watts JR Jr, Powers TA. Searching for the Source of the Leak: PIE and the Macklin Effect. Ann Am Thorac Soc. 2018 Nov;15(11):1354-1356. doi: 10.1513/AnnalsATS.201803-200CC. No abstract available.
- Background: PubMed 33678544Belletti A, Palumbo D, Zangrillo A, Fominskiy EV, Franchini S, Dell'Acqua A, Marinosci A, Monti G, Vitali G, Colombo S, Guazzarotti G, Lembo R, Maimeri N, Faustini C, Pennella R, Mushtaq J, Landoni G, Scandroglio AM, Dagna L, De Cobelli F; COVID-BioB Study Group. Predictors of Pneumothorax/Pneumomediastinum in Mechanically Ventilated COVID-19 Patients. J Cardiothorac Vasc Anesth. 2021 Dec;35(12):3642-3651. doi: 10.1053/j.jvca.2021.02.008. Epub 2021 Feb 6.
- Background: PubMed 34392131Palumbo D, Zangrillo A, Belletti A, Guazzarotti G, Calvi MR, Guzzo F, Pennella R, Monti G, Gritti C, Marmiere M, Rocchi M, Colombo S, Valsecchi D, Scandroglio AM, Dagna L, Rovere-Querini P, Tresoldi M, Landoni G, De Cobelli F; COVID-BioB Study Group. A radiological predictor for pneumomediastinum/pneumothorax in COVID-19 ARDS patients. J Crit Care. 2021 Dec;66:14-19. doi: 10.1016/j.jcrc.2021.07.022. Epub 2021 Aug 12.
- Background: PubMed 35512457Paternoster G, Belmonte G, Scarano E, Rotondo P, Palumbo D, Belletti A, Corradi F, Bertini P, Landoni G, Guarracino F; COVID-Macklin Study Group. Macklin effect on baseline chest CT scan accurately predicts barotrauma in COVID-19 patients. Respir Med. 2022 Jun;197:106853. doi: 10.1016/j.rmed.2022.106853. Epub 2022 Apr 20.
- Background: PubMed 35537972Paternoster G, Bertini P, Belletti A, Landoni G, Gallotta S, Palumbo D, Isirdi A, Guarracino F. Venovenous Extracorporeal Membrane Oxygenation in Awake Non-Intubated Patients With COVID-19 ARDS at High Risk for Barotrauma. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):2975-2982. doi: 10.1053/j.jvca.2022.03.011. Epub 2022 Mar 17.
- Background: PubMed 33971530Mori M, Palumbo D, De Lorenzo R, Broggi S, Compagnone N, Guazzarotti G, Giorgio Esposito P, Mazzilli A, Steidler S, Pietro Vitali G, Del Vecchio A, Rovere Querini P, De Cobelli F, Fiorino C. Robust prediction of mortality of COVID-19 patients based on quantitative, operator-independent, lung CT densitometry. Phys Med. 2021 May;85:63-71. doi: 10.1016/j.ejmp.2021.04.022. Epub 2021 Apr 30.
- Background: PubMed 35839667Mori M, Alborghetti L, Palumbo D, Broggi S, Raspanti D, Rovere Querini P, Del Vecchio A, De Cobelli F, Fiorino C. Atlas-based lung segmentation combined with automatic densitometry characterization in COVID-19 patients: Training, validation and first application in a longitudinal study. Phys Med. 2022 Aug;100:142-152. doi: 10.1016/j.ejmp.2022.06.018. Epub 2022 Jul 4.
- Background: PubMed 34638421Palumbo D, Mori M, Prato F, Crippa S, Belfiori G, Reni M, Mushtaq J, Aleotti F, Guazzarotti G, Cao R, Steidler S, Tamburrino D, Spezi E, Del Vecchio A, Cascinu S, Falconi M, Fiorino C, De Cobelli F. Prediction of Early Distant Recurrence in Upfront Resectable Pancreatic Adenocarcinoma: A Multidisciplinary, Machine Learning-Based Approach. Cancers (Basel). 2021 Sep 30;13(19):4938. doi: 10.3390/cancers13194938.
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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.
Giovanni Landoni, Professor study chair
Università Vita-Salute San Raffaele
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Barotrauma, run by Università Vita-Salute San Raffaele at 2 sites in Italy.
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 2 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: looking for participants now, as of the sponsor's last update on 6 Aug 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diego Palumbo, MD (+39022643 ext. 2529, palumbo.diego@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinically relevant barotrauma (time frame: 30 days or until hospital discharge. Specifically, from date of basal CT scan until the date of first radiologically documented barotrauma.). 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 NCT05816954, which also lists 13 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 6 Aug 2025.