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Acute Respiratory Distress SyndromeNCT05765760

Improvement of ARDS Ventilation-perfusion Matching by Prone Positioning Assessed by EIT

An observational study of Acute Respiratory Distress Syndrome and Prone Position, run by Beijing Chao Yang Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Acute Respiratory Distress Syndrome (ARDS) is a highly lethal disease with limited treatment options. In recent years, prone position ventilation has been shown to improve the mortality rate and lung injury of ARDS patients by promoting lung recruitment, improving ventilation/perfusion (V/Q) ratio, enhancing… Read more about this study

Who is it for?
Ages 18 years and older
How many people
77 participants
Where
1 siteChina
Study dates
1 Apr 2023to 31 May 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 years and older
  • All sexes
  • Adult, Older adult

Study population: ARDS Patients with PaO2/FiO2 < 150mmH

Who may be able to join

  • Age ≥ 18 years old;
  • meet the diagnostic criteria of Berlin's definition for ARDS;
  • invasive ventilation time < 48h;
  • PaO2/FiO2 < 150mmHg.

Who cannot join

  • Contraindication to the prone position;
  • Contraindication to the EIT;
  • Hemodynamically unstable;
  • Patients with hypernatremia;
  • Patients have received extracorporeal membrane oxygenation treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Chao-Yang Hospital

    Beijing, Beijing Municipality, 100020

Other trials in China

About this study

Official title: Improvement of Acute Respiratory Distress Syndrome Ventilation-perfusion Matching by Prone Positioning Assessed by Electrical Impedance Tomography

Acute Respiratory Distress Syndrome (ARDS) is a highly lethal disease with limited treatment options. In recent years, prone position ventilation has been shown to improve the mortality rate and lung injury of ARDS patients by promoting lung recruitment, improving ventilation/perfusion (V/Q) ratio, enhancing respiratory system compliance, promoting sputum drainage, and effectively avoiding overinflation of the dorsal lung. Electrical Impedance Tomography (EIT) technology has been used to evaluate the effect of prone position ventilation on lung V/Q matching, and some studies have confirmed that prone position ventilation can improve lung V/Q matching and oxygenation index. However, previous studies were mostly case reports or small-sample physiological studies that lacked dynamic changes in lung V/Q matching during repeated prone position ventilation. Therefore, this study hypothesizes that prone position ventilation can increase lung V/Q matching in ARDS patients, and its improvement is correlated with changes in oxygenation index, invasive ventilation time, and patient prognosis. Repeated prone position ventilation can maintain lung V/Q matching at a higher level, no longer affected by changes in body position, which can accelerate pulmonary function recovery and improve the prognosis of ARDS patients.

Medical subject headings
Respiratory Distress Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ICU mortality

    The death of patients that occurs during their stay in the ICU

    Measured: 28 days after enrollment

Secondary outcomes (1)

  1. Ventilator-free days

    Days without receiving invasive ventilation at day 28.

    Measured: 28 days after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start1 Apr 2023
  3. Primary completion30 Apr 2025
  4. Study completion31 May 2025

Resources

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
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05765760
Sponsor's protocol ID
2022-KE-615
Status last verified
Jun 2025
First submitted
28 Feb 2023
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

    PubMed 26903337

  • Attaway AH, Scheraga RG, Bhimraj A, Biehl M, Hatipoglu U. Severe covid-19 pneumonia: pathogenesis and clinical management. BMJ. 2021 Mar 10;372:n436. doi: 10.1136/bmj.n436.

    PubMed 33692022

  • Slobod D, Damia A, Leali M, Spinelli E, Mauri T. Pathophysiology and Clinical Meaning of Ventilation-Perfusion Mismatch in the Acute Respiratory Distress Syndrome. Biology (Basel). 2022 Dec 30;12(1):67. doi: 10.3390/biology12010067.

    PubMed 36671759

  • Borges JB, Costa EL, Bergquist M, Lucchetta L, Widstrom C, Maripuu E, Suarez-Sipmann F, Larsson A, Amato MB, Hedenstierna G. Lung inflammation persists after 27 hours of protective Acute Respiratory Distress Syndrome Network Strategy and is concentrated in the nondependent lung. Crit Care Med. 2015 May;43(5):e123-32. doi: 10.1097/CCM.0000000000000926.

    PubMed 25746507

  • Borges JB, Hansen T, Larsson A, Hedenstierna G. The "normal" ventilated airspaces suffer the most damaging effects of mechanical ventilation. Intensive Care Med. 2017 Jul;43(7):1057-1058. doi: 10.1007/s00134-017-4708-1. Epub 2017 Feb 15. No abstract available.

    PubMed 28204859

  • Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.

    PubMed 17038660

  • Rampon GL, Simpson SQ, Agrawal R. Prone Positioning for Acute Hypoxemic Respiratory Failure and ARDS: A Review. Chest. 2023 Feb;163(2):332-340. doi: 10.1016/j.chest.2022.09.020. Epub 2022 Sep 23.

    PubMed 36162482

  • Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.

    PubMed 24134414

  • Fernandez R, Trenchs X, Klamburg J, Castedo J, Serrano JM, Besso G, Tirapu JP, Santos A, Mas A, Parraga M, Jubert P, Frutos F, Anon JM, Garcia M, Rodriguez F, Yebenes JC, Lopez MJ. Prone positioning in acute respiratory distress syndrome: a multicenter randomized clinical trial. Intensive Care Med. 2008 Aug;34(8):1487-91. doi: 10.1007/s00134-008-1119-3. Epub 2008 Apr 22.

    PubMed 18427774

  • Taccone P, Pesenti A, Latini R, Polli F, Vagginelli F, Mietto C, Caspani L, Raimondi F, Bordone G, Iapichino G, Mancebo J, Guerin C, Ayzac L, Blanch L, Fumagalli R, Tognoni G, Gattinoni L; Prone-Supine II Study Group. Prone positioning in patients with moderate and severe acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2009 Nov 11;302(18):1977-84. doi: 10.1001/jama.2009.1614.

    PubMed 19903918

  • 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.

    PubMed 23688302

  • Mathews KS, Soh H, Shaefi S, Wang W, Bose S, Coca S, Gupta S, Hayek SS, Srivastava A, Brenner SK, Radbel J, Green A, Sutherland A, Leonberg-Yoo A, Shehata A, Schenck EJ, Short SAP, Hernan MA, Chan L, Leaf DE; STOP-COVID Investigators. Prone Positioning and Survival in Mechanically Ventilated Patients With Coronavirus Disease 2019-Related Respiratory Failure. Crit Care Med. 2021 Jul 1;49(7):1026-1037. doi: 10.1097/CCM.0000000000004938.

    PubMed 33595960

  • Mojoli F, Bouhemad B, Mongodi S, Lichtenstein D. Lung Ultrasound for Critically Ill Patients. Am J Respir Crit Care Med. 2019 Mar 15;199(6):701-714. doi: 10.1164/rccm.201802-0236CI.

    PubMed 30372119

  • Jimenez JV, Weirauch AJ, Culter CA, Choi PJ, Hyzy RC. Electrical Impedance Tomography in Acute Respiratory Distress Syndrome Management. Crit Care Med. 2022 Aug 1;50(8):1210-1223. doi: 10.1097/CCM.0000000000005582. Epub 2022 May 23.

    PubMed 35607967

  • He HW, Long Y, Chi Y, Yuan SY, Zhou X, Su LX, Cheng W, Fu F, Zhao ZQ. [Technology specification of bedside hypertonic saline-contrast electrical impedance tomography of lung perfusion and clinical application]. Zhonghua Yi Xue Za Zhi. 2021 Apr 20;101(15):1097-1101. doi: 10.3760/cma.j.cn112137-20200926-02723. Chinese.

    PubMed 33878839

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Distress Syndrome and Prone Position, run by Beijing Chao Yang Hospital at 1 site in China.

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 4 inclusion and 5 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 15 Jun 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 China. 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?

ICU mortality (time frame: 28 days after enrollment). 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 NCT05765760, which also lists 20 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 15 Jun 2025.

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