Critical IllnessNCT05873647
Effect of Inhaled Nitric Oxide on Pulmonary Ventilation/Perfusion Ratio Assessed by EIT in Patients With ARDS
An observational study of Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Electrical impedance tomography was used to monitor changes in pulmonary perfusion distribution and V/Q ratio before and after iNO in patients with acute respiratory distress syndrome to investigate the factors predicting iNO reactivity and the physiological mechanism underlying changes in oxygenation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ARDS
Who may be able to join
- Patients aged ≥ 18 years;
- Patients are intubated and mechanically ventilated.
Who cannot join
- EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc;
- With a history of cerebral hemorrhage in the past half year, as well as bleeding in any site of the body;
- Pneumothorax;
- Medium or massive pleural effusion;
- Refractory shock;
- Pregnant
Show all 9Show fewer
- With chronic kidney disease
- Atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output;
- Failure to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hongling Zhang
Wuhan, Hubei, 430000
Hongling Zhang, master, +862785726375 ext. 027-85351607, 81243895@qq.com
About this study
Official title: Effect of Inhaled Nitric Oxide on Pulmonary Ventilation/Perfusion Ratio Assessed by Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome
Electrical impedance tomography was used to monitor changes in pulmonary perfusion distribution and V/Q ratio before and after iNO in patients with acute respiratory distress syndrome to investigate the factors predicting iNO reactivity and the physiological mechanism underlying changes in oxygenation.
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ventilation/perfusion ration
Lung ventilation/perfusion ration after iNO assessed by EIT
Measured: 3 hours
Secondary outcomes (8)
Lung perfusion distribution
Lung ventilation/perfusion ration after iNO assessed by EIT
Measured: 30minutes and 3 hours
Shunting
Lung shunting% after iNO assessed by EIT
Measured: 30minutes and 3 hours
Dead space
Lung dead space after iNO assessed by EIT
Measured: 30minutes and 3 hours
Oxygenation index
Oxygenation index= arterial partial pressure of oxygen/fraction of inspired oxygen
Measured: 30minutes and 3 hours
Arterial partial pressure of carbon dioxide (PaCO2)
PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis.
Measured: 30minutes and 3 hours
Static respiratory compliance (Crs)
Crs=tidal volume/driving pressure
Measured: 30minutes and 3 hours
Cardiac output
Cardiac output assessed by echocardiography
Measured: 30minutes and 3 hours
Right ventricular function
Right ventricular function assessed by echocardiography
Measured: 30minutes and 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaoJing Zou,MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873647
- Sponsor's protocol ID
- INOEIT20230404
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inhaled Nitric Oxide on Pulmonary Ventilation/Perfusion Ratio Assessed by Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05873647
- Acronym / sponsor ID
- INOEIT20230404
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 24 May 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.
Electrical impedance tomography was used to monitor changes in pulmonary perfusion distribution and V/Q ratio before and after iNO in patients with acute respiratory distress syndrome to investigate the factors predicting iNO reactivity and the physiological mechanism underlying changes in oxygenation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ARDS
Key inclusion criteria (2 listed)
- Patients aged ≥ 18 years;
- Patients are intubated and mechanically ventilated.
Key exclusion criteria (9 listed)
- EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc;
- With a history of cerebral hemorrhage in the past half year, as well as bleeding in any site of the body;
- Pneumothorax;
- Medium or massive pleural effusion;
- Refractory shock;
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
Lung ventilation/perfusion ration
Time frame: 3 hours
Lung ventilation/perfusion ration after iNO assessed by EIT
8 secondary outcomes
Lung perfusion distribution
Time frame: 30minutes and 3 hours
Shunting
Time frame: 30minutes and 3 hours
Dead space
Time frame: 30minutes and 3 hours
Oxygenation index
Time frame: 30minutes and 3 hours
Arterial partial pressure of carbon dioxide (PaCO2)
Time frame: 30minutes and 3 hours
Static respiratory compliance (Crs)
Time frame: 30minutes and 3 hours
Cardiac output
Time frame: 30minutes and 3 hours
Right ventricular function
Time frame: 30minutes and 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
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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.
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 Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 2 inclusion and 9 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 24 May 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 Xiaojing Zou, prof. (+862785351606, 249126734@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung ventilation/perfusion ration (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2023.