- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05873647
Effect of Inhaled Nitric Oxide on Pulmonary Ventilation/Perfusion Ratio Assessed by EIT in Patients With ARDS
May 15, 2023 updated by: XiaoJing Zou,MD, Wuhan Union Hospital, China
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaojing Zou, prof.
- Phone Number: +862785351606
- Email: 249126734@qq.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Recruiting
- Hongling Zhang
-
Contact:
- Hongling Zhang, master
- Phone Number: 027-85351607 +862785726375
- Email: 81243895@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with ARDS
Description
Inclusion Criteria:
- Patients aged ≥ 18 years;
- Patients are intubated and mechanically ventilated.
Exclusion Criteria:
- 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
- With chronic kidney disease
- Atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output;
- Failure to sign informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung ventilation/perfusion ration
Time Frame: 3 hours
|
Lung ventilation/perfusion ration after iNO assessed by EIT
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung perfusion distribution
Time Frame: 30minutes and 3 hours
|
Lung ventilation/perfusion ration after iNO assessed by EIT
|
30minutes and 3 hours
|
|
Shunting
Time Frame: 30minutes and 3 hours
|
Lung shunting% after iNO assessed by EIT
|
30minutes and 3 hours
|
|
Dead space
Time Frame: 30minutes and 3 hours
|
Lung dead space after iNO assessed by EIT
|
30minutes and 3 hours
|
|
Oxygenation index
Time Frame: 30minutes and 3 hours
|
Oxygenation index= arterial partial pressure of oxygen/fraction of inspired oxygen
|
30minutes and 3 hours
|
|
Arterial partial pressure of carbon dioxide (PaCO2)
Time Frame: 30minutes and 3 hours
|
PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis.
|
30minutes and 3 hours
|
|
Static respiratory compliance (Crs)
Time Frame: 30minutes and 3 hours
|
Crs=tidal volume/driving pressure
|
30minutes and 3 hours
|
|
Cardiac output
Time Frame: 30minutes and 3 hours
|
Cardiac output assessed by echocardiography
|
30minutes and 3 hours
|
|
Right ventricular function
Time Frame: 30minutes and 3 hours
|
Right ventricular function assessed by echocardiography
|
30minutes and 3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Anticipated)
May 1, 2025
Study Completion (Anticipated)
May 1, 2025
Study Registration Dates
First Submitted
May 10, 2023
First Submitted That Met QC Criteria
May 15, 2023
First Posted (Actual)
May 24, 2023
Study Record Updates
Last Update Posted (Actual)
May 24, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INOEIT20230404
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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