Effect of Inhaled Nitric Oxide on Pulmonary Ventilation/Perfusion Ratio Assessed by EIT in Patients With ARDS

• Sponsor: Wuhan Union Hospital, China (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05873647
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Inhaled Nitric Oxide on Pulmonary Ventilation/Perfusion Ratio Assessed by Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome
• Actual Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: May 1, 2025

Outcome Measures

Primary Outcome Measures

1. Lung ventilation/perfusion ration [3 hours]

   Lung ventilation/perfusion ration after iNO assessed by EIT

Secondary Outcome Measures

1. Lung perfusion distribution [30minutes and 3 hours]

   Lung ventilation/perfusion ration after iNO assessed by EIT

2. Shunting [30minutes and 3 hours]

   Lung shunting% after iNO assessed by EIT

3. Dead space [30minutes and 3 hours]

   Lung dead space after iNO assessed by EIT

4. Oxygenation index [30minutes and 3 hours]

   Oxygenation index= arterial partial pressure of oxygen/fraction of inspired oxygen

5. Arterial partial pressure of carbon dioxide (PaCO2) [30minutes and 3 hours]

   PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis.

6. Static respiratory compliance (Crs) [30minutes and 3 hours]

   Crs=tidal volume/driving pressure

7. Cardiac output [30minutes and 3 hours]

   Cardiac output assessed by echocardiography

8. Right ventricular function [30minutes and 3 hours]

   Right ventricular function assessed by echocardiography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hongling Zhang	Wuhan	Hubei	China	430000

Sponsors and Collaborators

• Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: XiaoJing Zou,MD, Clinical Professor, Wuhan Union Hospital, China
• ClinicalTrials.gov Identifier: NCT05873647
• Other Study ID Numbers: INOEIT20230404
• First Posted: May 24, 2023
• Last Update Posted: May 24, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of May 24, 2023