ARDS (Acute Respiratory Distress Syndrome)NCT06868810
Comparison of 5% Nacl and 10% NaHCO3 As Contrast Agents for Lung Perfusion with EIT
A study testing Injection of hypertonic saline and Injection of 5% NaHCO3 in people with ARDS (Acute Respiratory Distress Syndrome), run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- Injection of hypertonic saline and Injection of 5% NaHCO3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 26 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In need of lung perfusion assessment due to clinical condition
- With central venous catheter
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Comparison of 5% Sodium Bicarbonate and 10% Sodium Chloride As Contrast Agents for Lung Perfusion with Electrical Impedance Tomography: a Prospective Clinical Study
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.
- Being tested
- Injection of hypertonic saline, Injection of 5% NaHCO3
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of hypertonic salineOther
Injection 10 mL of 10% NaCl through central venous catheter
Injection of 5% NaHCO3Other
Injection of 5% NaHCO3 through central venous catheter
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Injection of hypertonic saline; Other: Injection of 5% NaHCO3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung perfusion distribution in ROI
Measured: Offline analysis, immediately after the saline injection procedure
Secondary outcomes (1)
V/Q match in ROI
Measured: Offline analysis, immediately after the saline injection procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Apr 2024
- Primary completion14 Jul 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868810
- Sponsor's protocol ID
- EIT contrast agent
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 5% Sodium Bicarbonate and 10% Sodium Chloride As Contrast Agents for Lung Perfusion with Electrical Impedance Tomography: a Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06868810
- Acronym / sponsor ID
- EIT contrast agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 14 Jul 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NaCl | Experimental | Other: Injection of hypertonic saline, Other: Injection of 5% NaHCO3First, perform the EIT contrast method with 10% NaCl. After a 10-minute washout period, perform the EIT contrast method with 5% NaHCO3. |
| NaHCO3 | Other | Other: Injection of hypertonic saline, Other: Injection of 5% NaHCO3First, perform the EIT contrast method with 5% NaHCO3. After a 10-minute washout period, perform the EIT contrast method with 10% NaCl. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In need of lung perfusion assessment due to clinical condition
- With central venous catheter
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of hypertonic salineInjection 10 mL of 10% NaCl through central venous catheter | Other | NaCl, NaHCO3 |
| Injection of 5% NaHCO3Injection of 5% NaHCO3 through central venous catheter | Other | NaCl, NaHCO3 |
Primary outcome
lung perfusion distribution in ROI
Time frame: Offline analysis, immediately after the saline injection procedure
1 secondary outcome
V/Q match in ROI
Time frame: Offline analysis, immediately after the saline injection procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of hypertonic saline and Injection of 5% NaHCO3 in people with ARDS (Acute Respiratory Distress Syndrome), run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung perfusion distribution in ROI (time frame: Offline analysis, immediately after the saline injection procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.