Actively Recruiting

Age: 18Years +
All Genders
NCT07542366

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

Led by First Affiliated Hospital of Wannan Medical College · Updated on 2026-04-21

41

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 218 years2
  • 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
Not Eligible

You will not qualify if you...

  • Known pregnancy
  • Known allergy, intolerance, or contraindication to sodium bicarbonate or hypertonic saline
  • Severe arrhythmia or unstable cardiovascular status where small bolus injection is unsafe
  • Uncontrolled agitation or conditions preventing proper EIT belt placement (e.g., extensive chest wounds, large dressings, chest wall deformity)
  • Implanted electronic devices or metallic implants in the thoracic area contraindicating EIT
  • End-stage disease with expected survival of only a few hours deemed inappropriate by physician
  • Participation in another interventional trial interfering with EIT measurements or safety assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Anhui, China, 241001

Actively Recruiting

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Research Team

Q

qiancheng xu, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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