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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
RECRUITING
Wuhu
Contact Information
Primary
qiancheng xu, PhD
qianchengxu@wnmc.edu.cn
+86-18297529106
Time Frame
Start Date: 2024-09-26
Estimated Completion Date: 2026-09-25
Participants
Target number of participants: 41
Treatments
Mechanically Ventilated ICU Cohort
Adult ICU participants on controlled mechanical ventilation with a central venous catheter. Participants undergo bedside electrical impedance tomography (EIT) perfusion imaging during brief end-expiratory pauses. Two small intravenous contrast boluses are given in a prespecified sequence with adequate washout: 10% sodium chloride (hypertonic saline) and 5% sodium bicarbonate. Continuous physiologic monitoring is performed; blood gases/electrolytes may be obtained per clinical care. No randomization. Within-participant comparison of image quality, perfusion patterns, and short-term safety. Observational; EIT monitor used per routine care.
Sponsors
Leads: First Affiliated Hospital of Wannan Medical College

This content was sourced from clinicaltrials.gov