Respiratory Distress Syndrome, AdultNCT05715762
Determine the Effects of Prone Positioning and NO in COVID-19 ARDS by EIT
An observational study of Respiratory Distress Syndrome, Adult and COVID-19, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
We aims to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with COVID-19 associated acute respiratory distress syndrome by electrical impedance tomography. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, COVID-19
- What is being tested?
- prone postion and NO inhalation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2022to 31 Dec 2023
- How long will I take part?
- 1 Day
- 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 100 years
- All sexes
- Adult, Older adult
Study population: adult patients who have COVID-19-associated acute respiratory distress syndrome
Who may be able to join
- adult patients who have COVID-19-associated acute respiratory distress syndrome
Who cannot join
- patients who refuse to participate in the study; unable to use EIT, such as open-chest surgery with chest tube placement; have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Ming Zhong, PhD
About this study
Official title: Determine the Effects of Prone Positioning and Nitric Oxide in Adult COVID-19 Patients With ARDS by Electrical Impedance Tomography
We aims to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with COVID-19 associated acute respiratory distress syndrome by electrical impedance tomography.
Read the detailed description
The investigators aim to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with COVID-19 associated acute respiratory distress syndrome by electrical impedance tomography (EIT).
The EIT assessment is performed in patients ventilated in supine position, supine position with NO inhalation for 1 hour, prone position for 1 hour, prone position for 2 hours with NO inhalation for 1 hour, prone position for 3 hours, prone position for 16 hours, re-supine position for 3 hours. Arterial blood gas (ABG) analysis results, ventilator parameters and hemodynamic parameters are also recorded at each time point.
- Conditions
- Respiratory Distress Syndrome, Adult, COVID-19
- Being tested
- prone postion, NO inhalation
- Keywords
- Respiratory Distress Syndrome, COVID-19
- 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.
prone postionBehavioural
Also called PPV
ventilation at prone positioning
NO inhalationDrug
NO inhalation at 20 ppm
| Study group | Role | What they receive |
|---|---|---|
| Ventilation in supine position | Patients are ventilated in supine position. | |
| Ventilation in supine position and NO inhalation | Patients are ventilated in supine position with NO inhalation for 1 hour. Receives: Drug: NO inhalation | |
| Ventilation in prone position for 1 hour | Patients are ventilated in prone position for 1 hour. Receives: Behavioral: prone postion | |
| Ventilation in prone position for 2 hours plus NO inhalation for 1 hour | Patients are ventilated in prone position for 1 hour followed by ventilation in prone position with NO inhalation for 1 hour. Receives: Behavioral: prone postion; Drug: NO inhalation | |
| Ventilation in prone position for 3 hours | Patients are ventilated in prone position for 1 hour followed by ventilation in prone position with NO inhalation for 1 hour. Then they are ventilated in prone position alone for 1 hour. Receives: Behavioral: prone postion | |
| Ventilation in prone position for 16 hours | Patients are ventilated in prone position for 1 hour followed by ventilation in prone position with NO inhalation for 1 hour. Then they are ventilated in prone position alone for 14 hours. Receives: Behavioral: prone postion | |
| Ventilation in re-supine position for 3 hours | Patients are ventilated in supine position for 3 hours followed by ventilation in prone position for 16 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation status
To evaluate the oxygenation parameters
Measured: 1 day
regional distribution of pulmonary perfusion
To evaluate the effect of prone positon and NO inhalation on pulmonary blood flow distribution.
Measured: 1 day
regional distribution of pulmonary ventilation
To evaluate the effect of prone positon and NO inhalation on pulmonary vetilation distribution.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start21 Dec 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 Respiratory Distress Syndrome, AdultStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Zhong, PhD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715762
- Sponsor's protocol ID
- eit20221221
- Status last verified
- Dec 2022
- First submitted
- 28 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Dai Y, Zheng X, Zhu L, Muhetaer Y, Zhao Z, Liu K, Zhong M. EIT-assessed ventilation-perfusion responses to prone positioning and inhaled nitric oxide in mechanically ventilated COVID-19-related ARDS: a prospective sequential study. J Intensive Care. 2026 Jul 22;14(1):89. doi: 10.1186/s40560-026-00918-y.
PubMed 42675523
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Effects of Prone Positioning and Nitric Oxide in Adult COVID-19 Patients With ARDS by Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT05715762
- Acronym / sponsor ID
- eit20221221
- Conditions
- Respiratory Distress Syndrome, Adult, COVID-19
- Keywords
- Respiratory Distress Syndrome, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Feb 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.
We aims to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with COVID-19 associated acute respiratory distress syndrome by electrical impedance tomography.
Detailed description
The investigators aim to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with COVID-19 associated acute respiratory distress syndrome by electrical impedance tomography (EIT).
The EIT assessment is performed in patients ventilated in supine position, supine position with NO inhalation for 1 hour, prone position for 1 hour, prone position for 2 hours with NO inhalation for 1 hour, prone position for 3 hours, prone position for 16 hours, re-supine position for 3 hours. Arterial blood gas (ABG) analysis results, ventilator parameters and hemodynamic parameters are also recorded at each time point.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Ventilation in supine position | – | –Patients are ventilated in supine position. |
| Ventilation in supine position and NO inhalation | – | Drug: NO inhalationPatients are ventilated in supine position with NO inhalation for 1 hour. |
| Ventilation in prone position for 1 hour | – | Behavioral: prone postionPatients are ventilated in prone position for 1 hour. |
| Ventilation in prone position for 2 hours plus NO inhalation for 1 hour | – | Behavioral: prone postion, Drug: NO inhalationPatients are ventilated in prone position for 1 hour followed by ventilation in prone position with NO inhalation for 1 hour. |
| Ventilation in prone position for 3 hours | – | Behavioral: prone postionPatients are ventilated in prone position for 1 hour followed by ventilation in prone position with NO inhalation for 1 hour. Then they are ventilated in prone position alone for 1 hour. |
| Ventilation in prone position for 16 hours | – | Behavioral: prone postionPatients are ventilated in prone position for 1 hour followed by ventilation in prone position with NO inhalation for 1 hour. Then they are ventilated in prone position alone for 14 hours. |
| Ventilation in re-supine position for 3 hours | – | –Patients are ventilated in supine position for 3 hours followed by ventilation in prone position for 16 hours. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients who have COVID-19-associated acute respiratory distress syndrome
Key inclusion criteria (1 listed)
- adult patients who have COVID-19-associated acute respiratory distress syndrome
Key exclusion criteria (1 listed)
- patients who refuse to participate in the study; unable to use EIT, such as open-chest surgery with chest tube placement; have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure.
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 |
|---|---|---|
| prone postionAlso: PPVventilation at prone positioning | Behavioural | Ventilation in prone position for 1 hour, Ventilation in prone position for 16 hours, Ventilation in prone position for 2 hours plus NO inhalation for 1 hour, Ventilation in prone position for 3 hours |
| NO inhalationNO inhalation at 20 ppm | Drug | Ventilation in prone position for 2 hours plus NO inhalation for 1 hour, Ventilation in supine position and NO inhalation |
Primary outcome
oxygenation status
Time frame: 1 day
To evaluate the oxygenation parameters
regional distribution of pulmonary perfusion
Time frame: 1 day
To evaluate the effect of prone positon and NO inhalation on pulmonary blood flow distribution.
regional distribution of pulmonary ventilation
Time frame: 1 day
To evaluate the effect of prone positon and NO inhalation on pulmonary vetilation distribution.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 42675523Wang Y, Dai Y, Zheng X, Zhu L, Muhetaer Y, Zhao Z, Liu K, Zhong M. EIT-assessed ventilation-perfusion responses to prone positioning and inhaled nitric oxide in mechanically ventilated COVID-19-related ARDS: a prospective sequential study. J Intensive Care. 2026 Jul 22;14(1):89. doi: 10.1186/s40560-026-00918-y.
- 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.
Ming Zhong, PhD study chair
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 Respiratory Distress Syndrome, Adult and COVID-19, 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 8 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Zhong, 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?
oxygenation status (time frame: 1 day). 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 NCT05715762, 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 8 Feb 2023.