Lung InjuryPIOS-COVIDNCT05228717
Point-of-care Lung Ultrasound (POCUS)-Integrated Study of Admitted Patients With COVID-19
An observational study of Lung Injury and ARDS, run by Olive View-UCLA Education & Research Institute at 4 sites in United States.
Trial summary
This study seeks to define the ultrasound profile of patients with COVID-19, and document the progression of these ultrasound findings to develop prognostication and clinical decision instruments that can help guide management of patient with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Injury, ARDS, Acute Cardiac Event
- What is being tested?
- Point of Care Ultrasound
- How many people
- 240 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Nov 2020to Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients with COVID-19 Pneumonia/hypoxemic respiratory failure requiring at least 3L of O2.
Who may be able to join
- Patients with confirmed COVID-19 pneumonia as the primary diagnosis, or COVID- associated acute hypoxemic respiratory failure or hypoxia (minimum O2 requirement 3L), that are being admitted from the emergency department, who either have waiver of consent, give verbal consent to participate, or have next of kin give consent for participation.
Who cannot join
- age < 18 years old, pregnant patients, or patients that verbally refuse participation
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
UCLA-Ronald Reagan
Los Angeles, California, 90095
James Murphy, MD, 310-794-0785, jjmurphy@mednet.ucla.edu
George Lim, MD, 3107940785, gwlim@mednet.ucla.edu
- Recruiting
SUNY Downstate
New York, New York, 11203
Ian DeSouza, MD, ian.desouza@downstate.edu
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Ryan Gibbons, MD, ryan.gibbons@tuhs.temple.edu
- Recruiting
Olive View-UCLA
Sylmar, California, 91342
Alan Chiem, MD MPH, 747-210-3107, achiem@mednet.ucla.edu
About this study
Official title: Point-of-care Lung Ultrasound (POCUS)-Integrated Observation Study of Admitted Patients With COVID-19
This study seeks to define the ultrasound profile of patients with COVID-19, and document the progression of these ultrasound findings to develop prognostication and clinical decision instruments that can help guide management of patient with COVID-19. Primary aims include the development of ARDS, refractory hypoxemia, acute cardiac injury, pulmonary embolism, pneumothorax or death. Secondary aims include potential change in CT and plain film utilization given the use of POCUS, as well as emergency department and inpatient LOS (length of stay).
Read the detailed description
- SPECIFIC AIMS
- To define the lung ultrasound profile of patients admitted with COVID-19 pneumonia, hypoxia, or hypoxemic respiratory failure.
- To document the progression of POCUS findings in admitted patients with COVID-19 respiratory failure.
- Along with other clinical data, to develop a prognostication and clinical decision instrument that can help guide management of patients with COVID-19, specifically for the following specific outcomes:
- Development of ARDS, worsening oxygen requirement, or need for intubation. On POCUS, this would be associated with a shift in lateral lung involvement to anterior lung zone involvement; or overall increase in B-lines for all lung zones
- Refractory hypoxemia requiring lung recruitment maneuvers, including prone positioning or ECMO (extra-corporeal membrane oxygenation). On POCUS, this would be associated with the presence of posterior-lateral alveolar consolidation, which gives the appearance of "hepatization of lung"
- Development of acute cardiac injury, as defined by acute coronary syndrome or myocarditis. On POCUS, this would be associated with the development of worsening systolic function
- Development of pulmonary embolism as defined by CT evidence, +DVT (deep vein thrombosis), or therapeutic anticoagulation. On POCUS, this would be associated with a RV (right ventricle) strain pattern (D-shaped septum on parasternal short axis, RV>LV (left ventricle) diameter on apical)
- Development of pneumothorax. On POCUS, this would be associated with the absence of pleural sliding A composite outcome of development of ARDS, acute cardiac injury, hypoxemic respiratory failure requiring prone positioning or ECMO, PE (pulmonary embolism), PTX (pneumothorax), or death, will be used as the primary outcome. These are secondary aims that investigators will assess, but not base our power calculation on:
- To assess the potential change of using POCUS in CT and plain film utilization, as well as emergency department and inpatient LOS.
- If current triage workflow related to the COVID-19 pandemic integrates POCUS into triage, investigators will extend this analysis to the point of triage, and not just admitted patients.
- To assess the prevalence of lung ultrasound findings suggestive of COVID-19 infection in patients that present with acute coronary syndromes.
- Conditions
- Lung Injury, ARDS, Acute Cardiac Event, Covid19, Ultrasound, Hypoxemia
- Being tested
- Point of Care Ultrasound
- Medical subject headings
- Lung Injury, COVID-19, Hypoxia, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care UltrasoundDiagnostic test
q48-72h point of care ultrasound of the lungs, heart, and IVC (inferior vena cava)
| Study group | Role | What they receive |
|---|---|---|
| COVID+ | Patients with confirmed COVID-19 pneumonia as the primary diagnosis, or COVID-associated acute hypoxemic respiratory failure or hypoxia (minimum O2 requirement 3L), that are being admitted from the emergency department, who either have waiver of consent, give verbal consent to participate, or have NOK (next of kin) provide consent.
Exclusion criteria: age <18 years old, pregnant patients, or patients that verbally refuse participation Intervention/observation: q48-72h POCUS of the lungs, heart, and IVC Receives: Diagnostic Test: Point of Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of POCUS changes with major clinical events
Association of POCUS worsening with development of a composite outcome of development of ARDS, acute cardiac injury, hypoxemic respiratory failure requiring prone positioning or ECMO, pneumothorax, cardiac tamponade, or death.
Measured: From admission to 21 days, or endpoint reached
Time from POCUS worsening to clinical diagnosis.
Time interval from POCUS worsening to clinical diagnosis. Investigators will measure the duration between POCUS worsening and clinical diagnosis of any of the major clinical events described in outcome 1.
Measured: From admission to 21 days, or endpoint reached
Secondary outcomes (2)
Utilization of traditional radiography
To assess the potential change of using POCUS in CT and plain film utilization, as well as emergency department and inpatient LOS.
Measured: From admission to 21 days, or endpoint reached
Individual clinical outcomes
Investigators will compare POCUS changes and the time interval to development of each of the following outcomes: ARDS, acute cardiac injury, hypoxemic respiratory failure requiring prone positioning or ECMO, pneumothorax, cardiac tamponade, or death.
Measured: From admission to 21 days, or endpoint reached
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start10 Nov 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Lung InjuryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olive View-UCLA Education & Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228717
- Sponsor's protocol ID
- 1590419
- Acronym
- PIOS-COVID
- Status last verified
- Apr 2022
- First submitted
- 10 Mar 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.
PubMed 32101510Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
PubMed 20851923Buonsenso D, Pata D, Chiaretti A. COVID-19 outbreak: less stethoscope, more ultrasound. Lancet Respir Med. 2020 May;8(5):e27. doi: 10.1016/S2213-2600(20)30120-X. Epub 2020 Mar 20. No abstract available.
PubMed 32203708Chavez MA, Shams N, Ellington LE, Naithani N, Gilman RH, Steinhoff MC, Santosham M, Black RE, Price C, Gross M, Checkley W. Lung ultrasound for the diagnosis of pneumonia in adults: a systematic review and meta-analysis. Respir Res. 2014 Apr 23;15(1):50. doi: 10.1186/1465-9921-15-50.
PubMed 24758612Cheng Z, Lu Y, Cao Q, Qin L, Pan Z, Yan F, Yang W. Clinical Features and Chest CT Manifestations of Coronavirus Disease 2019 (COVID-19) in a Single-Center Study in Shanghai, China. AJR Am J Roentgenol. 2020 Jul;215(1):121-126. doi: 10.2214/AJR.20.22959. Epub 2020 Mar 14.
PubMed 32174128Chung M, Bernheim A, Mei X, Zhang N, Huang M, Zeng X, Cui J, Xu W, Yang Y, Fayad ZA, Jacobi A, Li K, Li S, Shan H. CT Imaging Features of 2019 Novel Coronavirus (2019-nCoV). Radiology. 2020 Apr;295(1):202-207. doi: 10.1148/radiol.2020200230. Epub 2020 Feb 4.
PubMed 32017661Clerkin KJ, Fried JA, Raikhelkar J, Sayer G, Griffin JM, Masoumi A, Jain SS, Burkhoff D, Kumaraiah D, Rabbani L, Schwartz A, Uriel N. COVID-19 and Cardiovascular Disease. Circulation. 2020 May 19;141(20):1648-1655. doi: 10.1161/CIRCULATIONAHA.120.046941. Epub 2020 Mar 21.
PubMed 32200663Copetti R, Soldati G, Copetti P. Chest sonography: a useful tool to differentiate acute cardiogenic pulmonary edema from acute respiratory distress syndrome. Cardiovasc Ultrasound. 2008 Apr 29;6:16. doi: 10.1186/1476-7120-6-16.
PubMed 18442425Dietrich CF, Mathis G, Cui XW, Ignee A, Hocke M, Hirche TO. Ultrasound of the pleurae and lungs. Ultrasound Med Biol. 2015 Feb;41(2):351-65. doi: 10.1016/j.ultrasmedbio.2014.10.002.
PubMed 25592455Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Hasan AA, Makhlouf HA. B-lines: Transthoracic chest ultrasound signs useful in assessment of interstitial lung diseases. Ann Thorac Med. 2014 Apr;9(2):99-103. doi: 10.4103/1817-1737.128856.
PubMed 24791173Henderson WR, Griesdale DE, Dominelli P, Ronco JJ. Does prone positioning improve oxygenation and reduce mortality in patients with acute respiratory distress syndrome? Can Respir J. 2014 Jul-Aug;21(4):213-5. doi: 10.1155/2014/472136. Epub 2014 Jun 13.
PubMed 24927376Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. doi: 10.1097/00000542-200401000-00006.
PubMed 14695718Lichtenstein DA, Lascols N, Meziere G, Gepner A. Ultrasound diagnosis of alveolar consolidation in the critically ill. Intensive Care Med. 2004 Feb;30(2):276-281. doi: 10.1007/s00134-003-2075-6. Epub 2004 Jan 13.
PubMed 14722643Mayo PH, Beaulieu Y, Doelken P, Feller-Kopman D, Harrod C, Kaplan A, Oropello J, Vieillard-Baron A, Axler O, Lichtenstein D, Maury E, Slama M, Vignon P. American College of Chest Physicians/La Societe de Reanimation de Langue Francaise statement on competence in critical care ultrasonography. Chest. 2009 Apr;135(4):1050-1060. doi: 10.1378/chest.08-2305. Epub 2009 Feb 2.
PubMed 19188546
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Lung Ultrasound (POCUS)-Integrated Observation Study of Admitted Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05228717
- Acronym / sponsor ID
- PIOS-COVID / 1590419
- Conditions
- Lung Injury, ARDS, Acute Cardiac Event, Covid19, Ultrasound, Hypoxemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Olive View-UCLA Education & Research InstituteUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to define the ultrasound profile of patients with COVID-19, and document the progression of these ultrasound findings to develop prognostication and clinical decision instruments that can help guide management of patient with COVID-19. Primary aims include the development of ARDS, refractory hypoxemia, acute cardiac injury, pulmonary embolism, pneumothorax or death. Secondary aims include potential change in CT and plain film utilization given the use of POCUS, as well as emergency department and inpatient LOS (length of stay).
Detailed description
- SPECIFIC AIMS
- To define the lung ultrasound profile of patients admitted with COVID-19 pneumonia, hypoxia, or hypoxemic respiratory failure.
- To document the progression of POCUS findings in admitted patients with COVID-19 respiratory failure.
- Along with other clinical data, to develop a prognostication and clinical decision instrument that can help guide management of patients with COVID-19, specifically for the following specific outcomes:
- Development of ARDS, worsening oxygen requirement, or need for intubation. On POCUS, this would be associated with a shift in lateral lung involvement to anterior lung zone involvement; or overall increase in B-lines for all lung zones
- Refractory hypoxemia requiring lung recruitment maneuvers, including prone positioning or ECMO (extra-corporeal membrane oxygenation). On POCUS, this would be associated with the presence of posterior-lateral alveolar consolidation, which gives the appearance of "hepatization of lung"
- Development of acute cardiac injury, as defined by acute coronary syndrome or myocarditis. On POCUS, this would be associated with the development of worsening systolic function
- Development of pulmonary embolism as defined by CT evidence, +DVT (deep vein thrombosis), or therapeutic anticoagulation. On POCUS, this would be associated with a RV (right ventricle) strain pattern (D-shaped septum on parasternal short axis, RV>LV (left ventricle) diameter on apical)
- Development of pneumothorax. On POCUS, this would be associated with the absence of pleural sliding A composite outcome of development of ARDS, acute cardiac injury, hypoxemic respiratory failure requiring prone positioning or ECMO, PE (pulmonary embolism), PTX (pneumothorax), or death, will be used as the primary outcome. These are secondary aims that investigators will assess, but not base our power calculation on:
- To assess the potential change of using POCUS in CT and plain film utilization, as well as emergency department and inpatient LOS.
- If current triage workflow related to the COVID-19 pandemic integrates POCUS into triage, investigators will extend this analysis to the point of triage, and not just admitted patients.
- To assess the prevalence of lung ultrasound findings suggestive of COVID-19 infection in patients that present with acute coronary syndromes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID+ | – | Diagnostic Test: Point of Care UltrasoundPatients with confirmed COVID-19 pneumonia as the primary diagnosis, or COVID-associated acute hypoxemic respiratory failure or hypoxia (minimum O2 requirement 3L), that are being admitted from the emergency department, who either have waiver of consent, give verbal consent to participate, or have NOK (next of kin) provide consent. Exclusion criteria: age <18 years old, pregnant patients, or patients that verbally refuse participation Intervention/observation: q48-72h POCUS of the lungs, heart, and IVC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients with COVID-19 Pneumonia/hypoxemic respiratory failure requiring at least 3L of O2.
Key inclusion criteria (1 listed)
- Patients with confirmed COVID-19 pneumonia as the primary diagnosis, or COVID- associated acute hypoxemic respiratory failure or hypoxia (minimum O2 requirement 3L), that are being admitted from the emergency department, who either have waiver of consent, give verbal consent to participate, or have next of kin give consent for participation.
Key exclusion criteria (1 listed)
- age < 18 years old, pregnant patients, or patients that verbally refuse participation
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 |
|---|---|---|
| Point of Care Ultrasoundq48-72h point of care ultrasound of the lungs, heart, and IVC (inferior vena cava) | Diagnostic test | COVID+ |
Primary outcome
Association of POCUS changes with major clinical events
Time frame: From admission to 21 days, or endpoint reached
Association of POCUS worsening with development of a composite outcome of development of ARDS, acute cardiac injury, hypoxemic respiratory failure requiring prone positioning or ECMO, pneumothorax, cardiac tamponade, or death.
Time from POCUS worsening to clinical diagnosis.
Time frame: From admission to 21 days, or endpoint reached
Time interval from POCUS worsening to clinical diagnosis. Investigators will measure the duration between POCUS worsening and clinical diagnosis of any of the major clinical events described in outcome 1.
2 secondary outcomes
Utilization of traditional radiography
Time frame: From admission to 21 days, or endpoint reached
Individual clinical outcomes
Time frame: From admission to 21 days, or endpoint reached
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Background: PubMed 32101510Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.
- Background: PubMed 20851923Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
- Background: PubMed 32203708Buonsenso D, Pata D, Chiaretti A. COVID-19 outbreak: less stethoscope, more ultrasound. Lancet Respir Med. 2020 May;8(5):e27. doi: 10.1016/S2213-2600(20)30120-X. Epub 2020 Mar 20. No abstract available.
- Background: PubMed 24758612Chavez MA, Shams N, Ellington LE, Naithani N, Gilman RH, Steinhoff MC, Santosham M, Black RE, Price C, Gross M, Checkley W. Lung ultrasound for the diagnosis of pneumonia in adults: a systematic review and meta-analysis. Respir Res. 2014 Apr 23;15(1):50. doi: 10.1186/1465-9921-15-50.
- Background: PubMed 32174128Cheng Z, Lu Y, Cao Q, Qin L, Pan Z, Yan F, Yang W. Clinical Features and Chest CT Manifestations of Coronavirus Disease 2019 (COVID-19) in a Single-Center Study in Shanghai, China. AJR Am J Roentgenol. 2020 Jul;215(1):121-126. doi: 10.2214/AJR.20.22959. Epub 2020 Mar 14.
- Background: PubMed 32017661Chung M, Bernheim A, Mei X, Zhang N, Huang M, Zeng X, Cui J, Xu W, Yang Y, Fayad ZA, Jacobi A, Li K, Li S, Shan H. CT Imaging Features of 2019 Novel Coronavirus (2019-nCoV). Radiology. 2020 Apr;295(1):202-207. doi: 10.1148/radiol.2020200230. Epub 2020 Feb 4.
- Background: PubMed 32200663Clerkin KJ, Fried JA, Raikhelkar J, Sayer G, Griffin JM, Masoumi A, Jain SS, Burkhoff D, Kumaraiah D, Rabbani L, Schwartz A, Uriel N. COVID-19 and Cardiovascular Disease. Circulation. 2020 May 19;141(20):1648-1655. doi: 10.1161/CIRCULATIONAHA.120.046941. Epub 2020 Mar 21.
- Background: PubMed 18442425Copetti R, Soldati G, Copetti P. Chest sonography: a useful tool to differentiate acute cardiogenic pulmonary edema from acute respiratory distress syndrome. Cardiovasc Ultrasound. 2008 Apr 29;6:16. doi: 10.1186/1476-7120-6-16.
- Background: PubMed 25592455Dietrich CF, Mathis G, Cui XW, Ignee A, Hocke M, Hirche TO. Ultrasound of the pleurae and lungs. Ultrasound Med Biol. 2015 Feb;41(2):351-65. doi: 10.1016/j.ultrasmedbio.2014.10.002.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background: PubMed 24791173Hasan AA, Makhlouf HA. B-lines: Transthoracic chest ultrasound signs useful in assessment of interstitial lung diseases. Ann Thorac Med. 2014 Apr;9(2):99-103. doi: 10.4103/1817-1737.128856.
- Background: PubMed 24927376Henderson WR, Griesdale DE, Dominelli P, Ronco JJ. Does prone positioning improve oxygenation and reduce mortality in patients with acute respiratory distress syndrome? Can Respir J. 2014 Jul-Aug;21(4):213-5. doi: 10.1155/2014/472136. Epub 2014 Jun 13.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Injury and ARDS, run by Olive View-UCLA Education & Research Institute at 4 sites in United States.
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: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Murphy, MD (7472103107, jjmurphy@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of POCUS changes with major clinical events (time frame: From admission to 21 days, or endpoint reached). The study lists 2 primary outcomes in all. 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 NCT05228717, which also lists 28 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 29 Apr 2022.