Comparison of 5% Nacl and 10% NaHCO3 As Contrast Agents for Lung Perfusion with EIT

March 9, 2025 updated by: Peking Union Medical College Hospital

Comparison of 5% Sodium Bicarbonate and 10% Sodium Chloride As Contrast Agents for Lung Perfusion with Electrical Impedance Tomography: a Prospective Clinical Study

Electrical impedance tomography (EIT) has enabled the bedside monitoring of lung perfusion measurement through the indicator-based contrast method. Currently, hypertonic sodium chloride is the most commonly used contrast agent for lung perfusion evaluation by EIT. However, concerns may be raised regarding the potential risks of hyperchloremia and possible acute kidney injury associated with the use of hypertonic NaCl. Recently, two experimental studies found sodium bicarbonate (NaHCO3) might be an alternative to hypertonic sodium chloride in lung perfusion assessment by EIT. However, whether NaHCO3 results in acceptable bias is unknown in critically ill patients. This clinical study aimed to further investigate the correlation and agreement of lung perfusion and Ventilation/perfusion (V/Q) match by EIT contrast method between two contrast indicators (5%NaHCO3 vs. 10% NaCl) in critically ill patients with respiratory failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • In need of lung perfusion assessment due to clinical condition
  • With central venous catheter

Exclusion Criteria:

  • contraindications to the use of EIT (automatic implantable cardioverter defibrillator, chest wounds limiting electrode belt placement, implantable pumps, etc.)
  • severe hyperchloremia (>155 mmol/L)
  • unable to tolerate breath-hold maneuver
  • pregnant or breastfeeding females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NaCl
First, perform the EIT contrast method with 10% NaCl. After a 10-minute washout period, perform the EIT contrast method with 5% NaHCO3.
Other: Injection of hypertonic saline
Injection 10 mL of 10% NaCl through central venous catheter
Other: Injection of 5% NaHCO3
Injection of 5% NaHCO3 through central venous catheter
Other: NaHCO3
First, perform the EIT contrast method with 5% NaHCO3. After a 10-minute washout period, perform the EIT contrast method with 10% NaCl.
Other: Injection of hypertonic saline
Injection 10 mL of 10% NaCl through central venous catheter
Other: Injection of 5% NaHCO3
Injection of 5% NaHCO3 through central venous catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lung perfusion distribution in ROI
Time Frame: Offline analysis, immediately after the saline injection procedure
Offline analysis, immediately after the saline injection procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
V/Q match in ROI
Time Frame: Offline analysis, immediately after the saline injection procedure
Offline analysis, immediately after the saline injection procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

July 14, 2024

Study Completion (Actual)

August 26, 2024

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIT contrast agent

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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