NCT07542366 The Feasibility of Pulmonary Perfusion Assessment Using Sodium Bicarbonate Contrast With Electrical Impedance Tomography: A Prospective Pilot Study
| NCT ID | NCT07542366 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Wannan Medical College |
| Condition | Acute Respiratory Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 41 participants |
| Start Date | 2024-09-26 |
| Primary Completion | 2026-09-25 |
Trial Parameters
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Brief 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 Criteria
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 electr