Acute Respiratory Distress SyndromeNCT05816928
Ventilation-Perfusion Matching in Early-stage Prone Position Ventilation
An observational study of Acute Respiratory Distress Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Prone positioning has been widely used in critical care medicine to improve oxygenation in patients with acute respiratory distress syndrome (ARDS). This study aimed to compare the effect of pronation on lung ventilation-perfusion matching between COVID19-associated acute respiratory distress syndrome (CARDS) and ARDS… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2021to 12 Apr 2021
- 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: The study population includes COVID19-associated ARDS patients and ARDS patients of other etiologies in the intensive care unit.
Who may be able to join
- Above the age of 18
- Diagnosed with ARDS based on the Berlin Definition of ARDS
- Under mechanical ventilation
Who cannot join
- Contraindications to EIT examination and prone position
- Refusal of signing the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ventilation-Perfusion Matching in Early-stage Prone Position Ventilation: A Comparison Between COVID-19 ARDS and ARDS From Other Etiologies
Prone positioning has been widely used in critical care medicine to improve oxygenation in patients with acute respiratory distress syndrome (ARDS). This study aimed to compare the effect of pronation on lung ventilation-perfusion matching between COVID19-associated acute respiratory distress syndrome (CARDS) and ARDS from other etiologies (non-CARDS) using electrical impedance tomography (EIT).
Read the detailed description
In this prospective study, both COVID19-associated ARDS (CARDS) patients and patients with ARDS from other etiologies (non-CARDS) were enrolled. Electrical impedance tomography (EIT) was used to evaluate the changes in ventilation and perfusion between supine and prone positions. Baseline values of the area of DeadSpace, shunt, ventilation-perfusion matching (VQmatch) were identified at the time of enrollment. Within the defined VQmatch region, the global inhomogeneity index (VQmatch-GI) was calculated to assess the degree of uniformity within the region. Prone position was applied immediately after the baseline data were collected. After 2 hours of proning, another EIT examination was conducted. Parameters such as DeadSpace, shunt, VQmatch, and other common measurements before and after pronation were taken and compared to evaluate the effect of prone positioning on CARDS and non-CARDS patients.
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, ICU, COVID19, Electrical impedance tomography
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID19-associated ARDS (CARDS) | This group included COVID19 patients with acute respiratory distress syndrome. Patients were put under prone position while their pulmonary function was measured using EIT before and after proning. | |
| Non-COVID19-associated ARDS (non-CARDS) | This group included patients with acute respiratory distress syndrome from other etiologies. Patients were put under prone position while their pulmonary function was measured using EIT before and after proning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DeadSpace
The area of Deadspace will be assessed using electrical impedance tomography
Measured: 3 months
Shunt
Shunt will be assessed using electrical impedance tomography
Measured: 3 months
Ventilation-perfusion matching (VQmatch)
VQmatch will be assessed using electrical impedance tomography
Measured: 3 months
Global inhomogeneity index (VQmatch-GI)
Within the defined VQmatch region assessed by electrical impedance tomography, the global inhomogeneity index (VQmatch-GI) was calculated to assess the degree of uniformity within the region.
Measured: 3 months
Secondary outcomes (4)
Ventilation
The ventilation of the lungs is assessed by electrical impedance tomography before and after prone positioning.
Measured: 3 months
Perfusion
The perfusion of the lungs is assessed by electrical impedance tomography before and after prone positioning.
Measured: 3 months
Center of Ventilation (CoV)
The center of ventilation of the lungs is assessed by electrical impedance tomography before and after prone positioning.
Measured: 3 months
Standard deviation of regional ventilation delay
The standard deviation of regional ventilation delay of the lungs is assessed by electrical impedance tomography before and after prone positioning.
Measured: 3 months
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 start12 Jan 2021
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Long, MD, Principal investigator, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816928
- Sponsor's protocol ID
- EIT20230403
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Y, Li H, Chi Y, Frerichs I, Zhao Z, Li Y, Zhang C, Chu H, He H, Long Y. Ventilation-perfusion matching in early-stage of prone position ventilation: a prospective cohort study between COVID-19 ARDS and ARDS from other etiologies. Physiol Meas. 2025 Jan 29;13(1). doi: 10.1088/1361-6579/ada8f1.
PubMed 39793207
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation-Perfusion Matching in Early-stage Prone Position Ventilation: A Comparison Between COVID-19 ARDS and ARDS From Other Etiologies
- ClinicalTrials.gov ID
- NCT05816928
- Acronym / sponsor ID
- EIT20230403
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, ICU, COVID19, Electrical impedance tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- 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.
Prone positioning has been widely used in critical care medicine to improve oxygenation in patients with acute respiratory distress syndrome (ARDS). This study aimed to compare the effect of pronation on lung ventilation-perfusion matching between COVID19-associated acute respiratory distress syndrome (CARDS) and ARDS from other etiologies (non-CARDS) using electrical impedance tomography (EIT).
Detailed description
In this prospective study, both COVID19-associated ARDS (CARDS) patients and patients with ARDS from other etiologies (non-CARDS) were enrolled. Electrical impedance tomography (EIT) was used to evaluate the changes in ventilation and perfusion between supine and prone positions. Baseline values of the area of DeadSpace, shunt, ventilation-perfusion matching (VQmatch) were identified at the time of enrollment. Within the defined VQmatch region, the global inhomogeneity index (VQmatch-GI) was calculated to assess the degree of uniformity within the region. Prone position was applied immediately after the baseline data were collected. After 2 hours of proning, another EIT examination was conducted. Parameters such as DeadSpace, shunt, VQmatch, and other common measurements before and after pronation were taken and compared to evaluate the effect of prone positioning on CARDS and non-CARDS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID19-associated ARDS (CARDS) | – | –This group included COVID19 patients with acute respiratory distress syndrome. Patients were put under prone position while their pulmonary function was measured using EIT before and after proning. |
| Non-COVID19-associated ARDS (non-CARDS) | – | –This group included patients with acute respiratory distress syndrome from other etiologies. Patients were put under prone position while their pulmonary function was measured using EIT before and after proning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes COVID19-associated ARDS patients and ARDS patients of other etiologies in the intensive care unit.
Key inclusion criteria (3 listed)
- Above the age of 18
- Diagnosed with ARDS based on the Berlin Definition of ARDS
- Under mechanical ventilation
Key exclusion criteria (2 listed)
- Contraindications to EIT examination and prone position
- Refusal of signing the informed consent
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
DeadSpace
Time frame: 3 months
The area of Deadspace will be assessed using electrical impedance tomography
Shunt
Time frame: 3 months
Shunt will be assessed using electrical impedance tomography
Ventilation-perfusion matching (VQmatch)
Time frame: 3 months
VQmatch will be assessed using electrical impedance tomography
Global inhomogeneity index (VQmatch-GI)
Time frame: 3 months
Within the defined VQmatch region assessed by electrical impedance tomography, the global inhomogeneity index (VQmatch-GI) was calculated to assess the degree of uniformity within the region.
4 secondary outcomes
Ventilation
Time frame: 3 months
Perfusion
Time frame: 3 months
Center of Ventilation (CoV)
Time frame: 3 months
Standard deviation of regional ventilation delay
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 39793207Yang Y, Li H, Chi Y, Frerichs I, Zhao Z, Li Y, Zhang C, Chu H, He H, Long Y. Ventilation-perfusion matching in early-stage of prone position ventilation: a prospective cohort study between COVID-19 ARDS and ARDS from other etiologies. Physiol Meas. 2025 Jan 29;13(1). doi: 10.1088/1361-6579/ada8f1.
- Individual participant dataSharing planned: No
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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.
Yun Long, MD principal investigator
Peking Union Medical College
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 Acute Respiratory Distress Syndrome, run by Peking Union Medical College 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 3 inclusion and 2 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 18 Apr 2023. 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?
DeadSpace (time frame: 3 months). The study lists 4 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 NCT05816928, which also lists 1 linked publication.
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 18 Apr 2023.