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Sodium Bicarbonate Contrast EIT Lung Perfusion Pilot Study

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Summary

NIH registered a prospective observational pilot study (NCT07542366) evaluating whether sodium bicarbonate can serve as a safe and effective contrast agent for electrical impedance tomography (EIT) imaging of lung blood flow in mechanically ventilated adults. The study will compare sodium bicarbonate (5%) against hypertonic saline (10% sodium chloride) within the same participants to assess image quality and short-term safety including effects on blood pressure, heart rhythm, and blood tests. Participants include adults with acute respiratory failure, ARDS, pneumonia, or critical illness in ICU settings.

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What changed

NIH registered a new observational pilot study (NCT07542366) titled 'The Feasibility of Pulmonary Perfusion Assessment Using Sodium Bicarbonate Contrast With Electrical Impedance Tomography: A Prospective Pilot Study.' The study aims to determine whether sodium bicarbonate (5%) can be used safely and effectively as a contrast agent for EIT imaging of pulmonary perfusion in mechanically ventilated adults, comparing it against hypertonic saline (10% sodium chloride) within the same participants.

This is a study registration notice with no compliance implications. Clinical investigators and healthcare institutions conducting ICU-based imaging research may find this relevant for understanding current feasibility研究方向. The study does not impose regulatory requirements or create reporting obligations for regulated entities.

Archived snapshot

Apr 22, 2026

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The Feasibility of Pulmonary Perfusion Assessment Using Sodium Bicarbonate Contrast With Electrical Impedance Tomography: A Prospective Pilot Study

Observational NCT07542366 Kind: OBSERVATIONAL Apr 21, 2026

Abstract

The goal of this observational pilot study is to learn if sodium bicarbonate can be used safely and effectively as a contrast agent to map lung blood flow using electrical impedance tomography (EIT) in adults on mechanical ventilation. Electrical impedance tomography (EIT) is a bedside imaging method that uses a soft belt with small sensors around the chest to track changes in electrical signals related to breathing and blood flow.

The main questions are:

Does sodium bicarbonate create clear, readable lung blood flow images with EIT? Are these images similar in quality and pattern to images made with hypertonic saline (10% sodium chloride)? Is the short-term safety profile acceptable, including effects on blood pressure, heart rhythm, and blood tests?

Researchers will compare two contrast agents within the same participant to see if image quality and lung blood flow patterns match:

Hypertonic saline (10% sodium chloride) Sodium bicarbonate (5%)

Participants will:

Have an EIT belt placed around the chest during routine ICU care Pause the ventilator briefly during image capture to reduce motion Receive two small intravenous boluses through an existing central line, one of hypertonic saline and one of sodium bicarbonate, with time between doses Have routine monitoring of vital signs; blood gases and electrolytes may be checked per clinical care Be observed for any short-term side effects Findings from this study will show whether sodium bicarbonate is a practical and sa...

Conditions: Acute Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Pneumonia, Critical Illness, Feasibility of Contrast-enhanced Electrical Impedance Tomography (EIT) for Pulmonary Perfusion Assessment in Mechanically Ventilated Adults

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Last updated

Classification

Agency
NIH
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Medical research protocol ICU patient monitoring
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Medical Devices

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