New Saline-contrast EIT Method Without Breath Hold by Low Pass Filter

July 15, 2025 updated by: Peking Union Medical College Hospital

A Novel Saline-contrast EIT Method for Lung Perfusion Estimation: Without Breath Hold by Low Frequency Band Pass Filter

The electrical impedance tomography (EIT) is a bedside, non-invasive, non-radiation imaging tool for lung mornitoring. Currently, the EIT saline-contrast method for lung perfusion evaluation has been widely used in clinical. However, this technique requires the patient to hold breath for 8-30s to avoid the respiratory interference. Hence, it is not suitable for patients that can not tolerate breath hold or unable to maintain a steady apnoea. This study aims to develop an algorithm system based on low frequency band pass filter for EIT saline-contrast lung perfusion estimation without ventilation interruption, and investigate the correlation and agreement of EIT results between the novel method and the conventional breath-hold method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

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:

  • Pregnant or breastfeeding females
  • 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
  • edema disease (nephrotic syndrome, cirrhotic ascites, congestive heart failure, etc.)
  • Patients with severe hypernatraemia or hyperchloremia and severe hypertonicity
  • Hypertension (>160/100 mmHg), hypokalaemia (> 3.5 mmol/L)
  • Acute renal failure in oliguric stage, chronic renal failure with reduced urine output and poor response to diuretics

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: No apnea group
First, perform the EIT saline contrast method without apnea. After a 10-minute washout period, perform the conventional saline contrast method with apnea.
Other: Injection of hypertonic saline
Injection 10 mL of 10% NaCl through central venous catheter
Other: Apnea group
First, perform the conventional EIT saline contrast method with apnea. After a 10-minute washout period, perform the saline contrast method without apnea.
Other: Injection of hypertonic saline
Injection 10 mL of 10% NaCl through central venous catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Regional V/Q match
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
Pixel-wise lung perfusion fraction
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)

September 10, 2024

Primary Completion (Actual)

October 10, 2024

Study Completion (Actual)

October 15, 2024

Study Registration Dates

First Submitted

July 2, 2025

First Submitted That Met QC Criteria

July 15, 2025

First Posted (Actual)

July 23, 2025

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIT-No breath hold

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

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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