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Non-apnea Electrical Impedance Tomography for Bedside Ventilation-Perfusion Assessment: a Prospective Cross-over Validation Study

NCT07489950 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-23

No results posted yet for this study

Summary

Title: Validating the Accuracy of Lung Blood Flow Monitoring Without Breath-Holding Under Spontaneous Breathing Support

Purpose: The purpose of this study is to evaluate the accuracy of a new Electrical Impedance Tomography (EIT) technique that measures lung blood flow (perfusion) without requiring patients to hold their breath. We aim to determine if this "non-apnea" method provides results consistent with the current clinical gold standard (the "pause" method).

Background: EIT is a non-invasive bedside tool used to monitor lung function. The traditional method for measuring lung blood flow requires patients to hold their breath for 5-8 seconds during a saline injection to avoid interference from breathing. However, many patients-especially those using a nasal cannula, high-flow nasal oxygen (HFNO), or pressure support ventilation (PSV)-must maintain continuous spontaneous breathing and find it difficult or unsafe to hold their breath. If a "non-apnea" method is proven accurate, it will make monitoring safer and easier for these patients.

What the Study Involves: The study includes stable adult patients who are breathing spontaneously. Each patient undergoes two measurements in a randomized order:

Standard Reference (Pause Method): Measurement taken during a brief, guided breath-hold.

Test Method (Non-Apnea Method): Measurement taken during normal, uninterrupted breathing while receiving respiratory support (Nasal Cannula, HFNO, or PSV).

Expected Significance: By comparing the lung images and ventilation/perfusion (V/Q) data from both methods, this study seeks to validate the reliability and precision of the non-apnea approach. This would allow clinicians to assess lung health in spontaneously breathing patients without interrupting their natural breathing rhythm.

Conditions

  • Pulmonary Perfusion
  • Ventilation-Perfusion Ratio
  • Respiratory Insufficiency
  • Critical Illness

Interventions

DIAGNOSTIC_TEST

Saline-contrast EIT with a non-apnea algorithm

Participants receive a central venous bolus injection of 10 mL 10% NaCl. Lung perfusion is then assessed using Electrical Impedance Tomography (EIT). The intervention evaluates two acquisition conditions: one during a brief respiratory pause (reference) and one during uninterrupted spontaneous breathing (test).

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Hongping Qu · Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-19
Primary Completion
2026-04-13
Completion
2026-04-13

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07489950 on ClinicalTrials.gov