A Prospective Clinical Study to Explore Response to Prone Positioning in ARDS Patients
NCT ID: NCT04692779
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
60 participants
OBSERVATIONAL
2021-01-31
2024-12-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Role of Pulmonary Perfusion on Tolerance to Supine Position in Patients With ARDS
NCT05408442
Diaphragm Ultrasound Vs Transpulmonary Pressure To Set PEEP in ARDS
NCT02463773
Physiological Studies in the Prone Position in Patients With ARDS
NCT06586736
Prevalence of Prone Positioning Use in ARDS Patients
NCT02842788
Hemodynamic Effect of Prone Position in Non-intubated Patient With COVID 19
NCT04834947
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intubated ARDS patients undergoing prone positioning
All intubated ARDS patients undergoing prone positioning will be assessed with LUS before and after prone positioning and before and after placing back in the supine position.
Lung Ultrasound (LUS)
Enrolled subjects will undergo LUS 1 hour before and 1 hour after prone positioning by a trained clinician and will be assessed using a LUS score based on LUS pattern. LUS will then be performed again 1 hour before supination (16 hours) and assessed by a LUS score. This process will be repeated on the first 3 prone sessions. Patients will be enrolled in the study for 4 weeks in order to observe patient outcomes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lung Ultrasound (LUS)
Enrolled subjects will undergo LUS 1 hour before and 1 hour after prone positioning by a trained clinician and will be assessed using a LUS score based on LUS pattern. LUS will then be performed again 1 hour before supination (16 hours) and assessed by a LUS score. This process will be repeated on the first 3 prone sessions. Patients will be enrolled in the study for 4 weeks in order to observe patient outcomes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. endotracheally intubated and receiving assisted mechanical ventilation
3. meet criteria for prone positioning: PaO2/FIO2 (P/F ratio) of ≤ 150 mm Hg with ventilator parameters of PEEP ≥ 10 cm H2O and FiO2 of .60
4. receive an order for prone positioning.
Exclusion Criteria
2. Tracheostomy
3. Receiving ECMO
4. Palliative care
5. Receive prone positioning more than once during intubation in an outside hospital
6. Receive invasive ventilation in an outside hospital for more than 72 hours
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rush University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tyler Weiss
Clinical Education Coordinator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tyler Weiss, MS
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Jie Li, PhD
Role: STUDY_CHAIR
Rush University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rush University Medical Center
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Arbelot C, Ferrari F, Bouhemad B, Rouby JJ. Lung ultrasound in acute respiratory distress syndrome and acute lung injury. Curr Opin Crit Care. 2008 Feb;14(1):70-4. doi: 10.1097/MCC.0b013e3282f43d05.
Bouhemad 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.
Bouhemad B, Zhang M, Lu Q, Rouby JJ. Clinical review: Bedside lung ultrasound in critical care practice. Crit Care. 2007;11(1):205. doi: 10.1186/cc5668.
Doerschug KC, Schmidt GA. Intensive care ultrasound: III. Lung and pleural ultrasound for the intensivist. Ann Am Thorac Soc. 2013 Dec;10(6):708-12. doi: 10.1513/AnnalsATS.201308-288OT. No abstract available.
Haddam M, Zieleskiewicz L, Perbet S, Baldovini A, Guervilly C, Arbelot C, Noel A, Vigne C, Hammad E, Antonini F, Lehingue S, Peytel E, Lu Q, Bouhemad B, Golmard JL, Langeron O, Martin C, Muller L, Rouby JJ, Constantin JM, Papazian L, Leone M; CAR'Echo Collaborative Network; AzuRea Collaborative Network. Lung ultrasonography for assessment of oxygenation response to prone position ventilation in ARDS. Intensive Care Med. 2016 Oct;42(10):1546-1556. doi: 10.1007/s00134-016-4411-7. Epub 2016 Jun 20.
Prat G, Guinard S, Bizien N, Nowak E, Tonnelier JM, Alavi Z, Renault A, Boles JM, L'Her E. Can lung ultrasonography predict prone positioning response in acute respiratory distress syndrome patients? J Crit Care. 2016 Apr;32:36-41. doi: 10.1016/j.jcrc.2015.12.015. Epub 2015 Dec 30.
Wang XT, Ding X, Zhang HM, Chen H, Su LX, Liu DW; Chinese Critical Ultrasound Study Group (CCUSG). Lung ultrasound can be used to predict the potential of prone positioning and assess prognosis in patients with acute respiratory distress syndrome. Crit Care. 2016 Nov 30;20(1):385. doi: 10.1186/s13054-016-1558-0.
Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.
Marini JJ, Hurford WE. Should Early Prone Positioning Be a Standard of Care in ARDS With Refractory Hypoxemia? Wrong Question-Reply. Respir Care. 2016 Nov;61(11):1564-1565. doi: 10.4187/respcare.05288. No abstract available.
Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.
Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271.
Reilly JP, Calfee CS, Christie JD. Acute Respiratory Distress Syndrome Phenotypes. Semin Respir Crit Care Med. 2019 Feb;40(1):19-30. doi: 10.1055/s-0039-1684049. Epub 2019 May 6.
Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.
Robba C, Battaglini D, Ball L, Patroniti N, Loconte M, Brunetti I, Vena A, Giacobbe DR, Bassetti M, Rocco PRM, Pelosi P. Distinct phenotypes require distinct respiratory management strategies in severe COVID-19. Respir Physiol Neurobiol. 2020 Aug;279:103455. doi: 10.1016/j.resp.2020.103455. Epub 2020 May 11.
Weiss TT, Cerda F, Scott JB, Kaur R, Sungurlu S, Mirza SH, Alolaiwat AA, Kaur R, Augustynovich AE, Li J. Prone positioning for patients intubated for severe acute respiratory distress syndrome (ARDS) secondary to COVID-19: a retrospective observational cohort study. Br J Anaesth. 2021 Jan;126(1):48-55. doi: 10.1016/j.bja.2020.09.042. Epub 2020 Oct 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ProneARDS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.