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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05873647
Other study ID # INOEIT20230404
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date May 1, 2025

Study information

Verified date May 2023
Source Wuhan Union Hospital, China
Contact Xiaojing Zou, prof.
Phone +862785351606
Email 249126734@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients aged = 18 years; 2. Patients are intubated and mechanically ventilated. Exclusion Criteria: 1. EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc; 2. With a history of cerebral hemorrhage in the past half year, as well as bleeding in any site of the body; 3. Pneumothorax; 4. Medium or massive pleural effusion; 5. Refractory shock; 6. Pregnant 7. With chronic kidney disease 8. Atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output; 9. Failure to sign informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Hongling Zhang Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lung ventilation/perfusion ration Lung ventilation/perfusion ration after iNO assessed by EIT 3 hours
Secondary Lung perfusion distribution Lung ventilation/perfusion ration after iNO assessed by EIT 30minutes and 3 hours
Secondary Shunting Lung shunting% after iNO assessed by EIT 30minutes and 3 hours
Secondary Dead space Lung dead space after iNO assessed by EIT 30minutes and 3 hours
Secondary Oxygenation index Oxygenation index= arterial partial pressure of oxygen/fraction of inspired oxygen 30minutes and 3 hours
Secondary 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. 30minutes and 3 hours
Secondary Static respiratory compliance (Crs) Crs=tidal volume/driving pressure 30minutes and 3 hours
Secondary Cardiac output Cardiac output assessed by echocardiography 30minutes and 3 hours
Secondary Right ventricular function Right ventricular function assessed by echocardiography 30minutes and 3 hours
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