The Feasibility of Pulmonary Perfusion Assessment Using Sodium Bicarbonate Contrast With Electric… (NCT07542366) | Clinical Trial Compass
RecruitingNot Applicable
The Feasibility of Pulmonary Perfusion Assessment Using Sodium Bicarbonate Contrast With Electrical Impedance Tomography: A Prospective Pilot Study
China41 participantsStarted 2024-09-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of analyzable sodium bicarbonate-enhanced EIT perfusion recordings
Timeframe: During the single EIT session on the study day (from contrast injection to completion of image reconstruction; within ~2 hours of enrollment)
Trial details
NCT IDNCT07542366
SponsorFirst Affiliated Hospital of Wannan Medical College