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

NCT06868810 | Completed

• 1 other identifier: EIT contrast agent
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Outcome Measures

Primary Outcomes (1)

• lung perfusion distribution in ROI

  Offline analysis, immediately after the saline injection procedure

Secondary Outcomes (1)

• V/Q match in ROI

  Offline analysis, immediately after the saline injection procedure

Study Arms (2)

NaCl

EXPERIMENTAL

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; Other: Injection of 5% NaHCO3

NaHCO3

OTHER

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; Other: Injection of 5% NaHCO3

Interventions

Injection of hypertonic saline OTHER

Injection 10 mL of 10% NaCl through central venous catheter

NaCl; NaHCO3

Injection of 5% NaHCO3 OTHER

Injection of 5% NaHCO3 through central venous catheter

NaCl; NaHCO3

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:

• 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

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

Acute Lung Injury

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

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: March 4, 2025
• First Posted: March 11, 2025
• Study Start: April 1, 2024
• Primary Completion: July 14, 2024
• Study Completion: August 26, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

CN (1)