ARDSNCT04725227
Determine the Effect of Prone Positioning in Adults With ARDS by Electrical Impedance Tomography
An observational study of ARDS and Prone Position, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
determine the effect of prone positioning on ventilation and perfusion distribution in adults with acute respiratory distress syndrome by electrical impedance tomography Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS, Prone Position, Electrical Impedance Tomography
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring mechanical ventilation are recieved prone position ventilation who admitted to the surgical ICU.
Who may be able to join
- patients who were undergoing mechanical ventilation with moderate-to-severe ARDS (defined as a Pao2:Fio2 ratio < 150 mm Hg with a positive end-expiratory pressure ≥ 5 cm of water, and an Fio2 of ≥ 0.6) according to the Berlin definition
Who cannot join
- contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Ming Zhong, MD, phD
About this study
Official title: Determine the Effect of Prone Positioning on Lung Ventilation and Perfusion Distribution in Adults With Acute Respiratory Distress Syndrome by Electrical Impedance Tomography
determine the effect of prone positioning on ventilation and perfusion distribution in adults with acute respiratory distress syndrome by electrical impedance tomography
Read the detailed description
By intravenous injection of a small amount of normal saline, electrical impedance tomography enables evaluation of the pulmonary blood flow. EIT might be helpful in establishing the hypoxemia etiology at bedside via combining regional ventilation and perfusion information. The objective of this study was to describe the physiological effects of prone position on respiratory mechanics, ventilation and pulmonary perfusion in patients with ARDS.
- Conditions
- ARDS, Prone Position, Electrical Impedance Tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess regional distribution of pulmonary perfusion
To evaluate the effect of prone positon on pulmonary blood flow distribution.
Measured: within 24 hours
Assess regional distribution of pulmonary ventilation
To evaluate the effect of prone positon on pulmonary vetilation distribution.
Measured: within 24 hours
Assess oxygenation status
To evaluate the effect of prone position by assessing regional distribution of pulmonary perfusion based on indicator dilution and changes at different points in time during varying states of regional ventilation will be evaluated.
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Zhong, Shanghai Zhongshan Hospital
- Investigators
- Ming Zhong, MD, phD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725227
- Sponsor's protocol ID
- P-E
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Muhetaer Y, Zheng X, Wu W, Tao J, Zhu L, Song J, Zhao Z, Zhong M. Time-dependent effects of prone position on ventilation-perfusion matching assessed by electrical impedance tomography in patients with COVID-19 ARDS: sub-analysis of a prospective physiological study. Ann Intensive Care. 2025 Mar 31;15(1):46. doi: 10.1186/s13613-025-01452-0.
PubMed 40163279Wang Y, Song J, Lin S, Zheng X, Zhao Z, Zhong M. Influence of Prone Position on Regional Ventilation/Perfusion Matching in Patients With ARDS Over Time. Respir Care. 2025 Jul;70(7):821-829. doi: 10.1089/respcare.12247. Epub 2025 Mar 5.
PubMed 40040422Wang YX, Zhong M, Dong MH, Song JQ, Zheng YJ, Wu W, Tao JL, Zhu L, Zheng X. Prone positioning improves ventilation-perfusion matching assessed by electrical impedance tomography in patients with ARDS: a prospective physiological study. Crit Care. 2022 May 27;26(1):154. doi: 10.1186/s13054-022-04021-0.
PubMed 35624489
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Effect of Prone Positioning on Lung Ventilation and Perfusion Distribution in Adults With Acute Respiratory Distress Syndrome by Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT04725227
- Acronym / sponsor ID
- P-E
- Conditions
- ARDS, Prone Position, Electrical Impedance Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Jan 2021 (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.
determine the effect of prone positioning on ventilation and perfusion distribution in adults with acute respiratory distress syndrome by electrical impedance tomography
Detailed description
By intravenous injection of a small amount of normal saline, electrical impedance tomography enables evaluation of the pulmonary blood flow. EIT might be helpful in establishing the hypoxemia etiology at bedside via combining regional ventilation and perfusion information. The objective of this study was to describe the physiological effects of prone position on respiratory mechanics, ventilation and pulmonary perfusion in patients with ARDS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring mechanical ventilation are recieved prone position ventilation who admitted to the surgical ICU.
Key inclusion criteria (1 listed)
- patients who were undergoing mechanical ventilation with moderate-to-severe ARDS (defined as a Pao2:Fio2 ratio < 150 mm Hg with a positive end-expiratory pressure ≥ 5 cm of water, and an Fio2 of ≥ 0.6) according to the Berlin definition
Key exclusion criteria (1 listed)
- contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess regional distribution of pulmonary perfusion
Time frame: within 24 hours
To evaluate the effect of prone positon on pulmonary blood flow distribution.
Assess regional distribution of pulmonary ventilation
Time frame: within 24 hours
To evaluate the effect of prone positon on pulmonary vetilation distribution.
Assess oxygenation status
Time frame: within 24 hours
To evaluate the effect of prone position by assessing regional distribution of pulmonary perfusion based on indicator dilution and changes at different points in time during varying states of regional ventilation will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Derived from this study: PubMed 40163279Wang Y, Muhetaer Y, Zheng X, Wu W, Tao J, Zhu L, Song J, Zhao Z, Zhong M. Time-dependent effects of prone position on ventilation-perfusion matching assessed by electrical impedance tomography in patients with COVID-19 ARDS: sub-analysis of a prospective physiological study. Ann Intensive Care. 2025 Mar 31;15(1):46. doi: 10.1186/s13613-025-01452-0.
- Derived from this study: PubMed 40040422Wang Y, Song J, Lin S, Zheng X, Zhao Z, Zhong M. Influence of Prone Position on Regional Ventilation/Perfusion Matching in Patients With ARDS Over Time. Respir Care. 2025 Jul;70(7):821-829. doi: 10.1089/respcare.12247. Epub 2025 Mar 5.
- Derived from this study: PubMed 35624489Wang YX, Zhong M, Dong MH, Song JQ, Zheng YJ, Wu W, Tao JL, Zhu L, Zheng X. Prone positioning improves ventilation-perfusion matching assessed by electrical impedance tomography in patients with ARDS: a prospective physiological study. Crit Care. 2022 May 27;26(1):154. doi: 10.1186/s13054-022-04021-0.
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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.
Ming Zhong, MD, phD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS and Prone Position, run by Shanghai Zhongshan 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 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 26 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Zhong, MD, phD (021-65642662, zhong.ming@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess regional distribution of pulmonary perfusion (time frame: within 24 hours). The study lists 3 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 NCT04725227, which also lists 3 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 26 Jan 2021.