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

NCT ID: NCT06868810

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-08-26

Brief Summary

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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.

Detailed Description

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Conditions

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ARDS (Acute Respiratory Distress Syndrome)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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NaCl

First, perform the EIT contrast method with 10% NaCl. After a 10-minute washout period, perform the EIT contrast method with 5% NaHCO3.

Group Type EXPERIMENTAL

Injection of hypertonic saline

Intervention Type OTHER

Injection 10 mL of 10% NaCl through central venous catheter

Injection of 5% NaHCO3

Intervention Type OTHER

Injection of 5% NaHCO3 through central venous catheter

NaHCO3

First, perform the EIT contrast method with 5% NaHCO3. After a 10-minute washout period, perform the EIT contrast method with 10% NaCl.

Group Type OTHER

Injection of hypertonic saline

Intervention Type OTHER

Injection 10 mL of 10% NaCl through central venous catheter

Injection of 5% NaHCO3

Intervention Type OTHER

Injection of 5% NaHCO3 through central venous catheter

Interventions

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Injection of hypertonic saline

Injection 10 mL of 10% NaCl through central venous catheter

Intervention Type OTHER

Injection of 5% NaHCO3

Injection of 5% NaHCO3 through central venous catheter

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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EIT contrast agent

Identifier Type: -

Identifier Source: org_study_id

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