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

NCT07542366 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Wannan Medical College

Phase

Observational

Started

2024-09-26

Last updated

2026-04-21

Condition(s) studied

Acute Respiratory FailureAcute Respiratory Distress Syndrome (ARDS)PneumoniaCritical IllnessFeasibility of Contrast-enhanced Electrical Impedance Tomography (EIT) for Pulmonary Perfusion Assessment in Mechanically Ventilated Adults

Study summary

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 safe option for EIT-based lung blood flow assessment and will guide larger future studies.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥ 18 years * Admitted to the intensive care unit (ICU) * Receiving invasive mechanical ventilation with controlled or assisted-controlled mode * Presence of a central venous catheter suitable for contrast bolus injection * Hemodynamically stable (no ongoing cardiopulmonary resuscitation; no uncontrolled shock judged by treating physician) * Expected to remain on mechanical ventilation for the duration of the EIT examination * Written informed consent obtained from the patient or legally authorized representative Exclusion Criteria: * Known pregnancy * Known allergy, intolerance, or contraindication to sodium bicarbonate or hypertonic saline * Severe arrhythmia or unstable cardiovascular status in which small bolus injection is deemed unsafe by the treating physician * Uncontrolled agitation or conditions that preclude correct EIT belt placement (e.g., extensive chest wounds, large chest dressings, chest wall deformity that prevents belt use) * Implanted electronic devices or metallic implants in the thoracic area considered a contraindication to EIT by the manufacturer's instructions * End-stage disease with expected survival of only a few hours, in whom participation is not appropriate as judged by the treating physician * Participation in another interventional trial that, in the opinion of the investigator, could interfere with EIT measurements or safety assessment

Primary outcome measure(s)

Proportion of analyzable sodium bicarbonate-enhanced EIT perfusion recordings — During the single EIT session on the study day (from contrast injection to completion of image reconstruction; within ~2 hours of enrollment)
Feasibility defined as the proportion of 5% sodium bicarbonate (NaHCO3) EIT perfusion acquisitions that meet predefined analyzable image quality criteria (clear first-pass bolus curve, no noncorrectable artifacts, successful reconstruction over expected thoracic region). Reported as n analyzable / n attempted, with 95% CI.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)	Wuhu	Anhui	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07542366 on ClinicalTrials.gov ↗ ← All trials in China