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

NCT07081295 | Completed

• 1 other identifier: EIT-No breath hold
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Regional V/Q match

  Offline analysis, immediately after the saline injection procedure

Secondary Outcomes (1)

• Pixel-wise lung perfusion fraction

  Offline analysis, immediately after the saline injection procedure

Study Arms (2)

No apnea group

EXPERIMENTAL

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

Apnea group

OTHER

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

Interventions

Injection of hypertonic saline OTHER

Injection 10 mL of 10% NaCl through central venous catheter

Apnea group; No apnea group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 23, 2025
• Study Start: September 10, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 15, 2024
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

CN (1)