Lung DiseasesNCT07081295
New Saline-contrast EIT Method Without Breath Hold by Low Pass Filter
A study testing Injection of hypertonic saline in people with Lung Diseases, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Injection of hypertonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 15 Oct 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
- 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
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: A Novel Saline-contrast EIT Method for Lung Perfusion Estimation: Without Breath Hold by Low Frequency Band Pass Filter
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
- Being tested
- Injection of hypertonic saline
- Medical subject headings
- Lung Diseases
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Injection of hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional V/Q match
Measured: Offline analysis, immediately after the saline injection procedure
Secondary outcomes (1)
Pixel-wise lung perfusion fraction
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 posted23 Jul 2025
- Study start10 Sep 2024
- Primary completion10 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- 22 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
- NCT07081295
- Sponsor's protocol ID
- EIT-No breath hold
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 23 Jul 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Saline-contrast EIT Method for Lung Perfusion Estimation: Without Breath Hold by Low Frequency Band Pass Filter
- ClinicalTrials.gov ID
- NCT07081295
- Acronym / sponsor ID
- EIT-No breath hold
- Conditions
- Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 23 Jul 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No apnea group | Experimental | Other: Injection of hypertonic salineFirst, perform the EIT saline contrast method without apnea. After a 10-minute washout period, perform the conventional saline contrast method with apnea. |
| Apnea group | Other | Other: Injection of hypertonic salineFirst, perform the conventional EIT saline contrast method with apnea. After a 10-minute washout period, perform the saline contrast method without apnea. |
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 (8 listed)
- 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.)
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 | Apnea group, No apnea group |
Primary outcome
Regional V/Q match
Time frame: Offline analysis, immediately after the saline injection procedure
1 secondary outcome
Pixel-wise lung perfusion fraction
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 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Diseases
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingObservational study
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
Brain Metastases, Bone Metastases
RecruitingPhase 2
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
Active, not recruitingPhase 3
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Carcinoma, Non-Small-Cell Lung
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 in people with Lung Diseases, 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 8 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 23 Jul 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?
Regional V/Q match (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 23 Jul 2025.