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ARDS, HumanNCT06164639

Potential Biomarkers and Pathogenic Mechanism for Reflux Aspiration-induced Lung Injury.

An observational study of ARDS, Human and Aspiration Pneumonia, run by Shanghai Zhongshan Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

There is limited research on aspiration pneumonia-induced ARDS (Acute Respiratory Distress Syndrome), and currently there is a lack of studies on corresponding biomarkers and pathogenic mechanisms. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
ARDS, Human, Aspiration Pneumonia
What is being tested?
aspiration, bronchial alveolar fluid and EIT V/Q test
How many people
28 participants
Where
1 siteChina
Study dates
28 Nov 2023to 28 Nov 2026
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with ARDS caused by inhalation pneumonia and patients with ARDS caused by other reasons.

Who may be able to join

  • The patient is between 18-99 years old. The patient meets the diagnostic criteria for ARDS upon admission to the ICU or during hospitalization, and requires mechanical ventilation with endotracheal intubation.
  • Within 24 hours of endotracheal intubation, bronchoscopy is performed for diagnostic or therapeutic purposes, and BALF is collected.
  • PH, amylase, and cytokines are tested within 24 hours. The patient, legal guardian, or authorized patient representative must voluntarily sign an informed consent form approved by the corresponding institutional review board. If the patient signs the consent form, the person obtaining consent must ensure that the patient is in a sufficient condition to provide informed consent.

Who cannot join

  • Clinical diagnosis of left ventricular failure Lung cancer-primary or metastatic Hematologic malignancy Acute gastrointestinal bleeding precluding enteral feeding Severe immunosuppression, defined as cytotoxic therapy within 15 days or White blood cell count of 5000 7) Use of steroids: 0.25 mg/kg/day of prednisone (or an equivalent dose of corticosteroids) Use of nonsteroidal anti-inflammatory (including aspirin) drugs within the last 24 hrs Known to be HIV positive Moribond at entry Pregnancy or positive pregnancy test

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Zhongshan Hospital Fudan University

    Shanghai

Other trials in China

About this study

Official title: Investigation of Potential Biomarkers in Bronchoalveolar Lavage Fluid and Exploration of the Pathogenic Mechanism Via EIT Examination for Reflux Aspiration-induced Alveolar Injury.

There is limited research on aspiration pneumonia-induced ARDS (Acute Respiratory Distress Syndrome), and currently there is a lack of studies on corresponding biomarkers and pathogenic mechanisms. We hypothesize that pH and amylase in BAL (Bronchoalveolar Lavage) may serve as candidate biomarkers for inhalation-induced ARDS. Furthermore, we use EIT analysis to explore the pathological mechanisms of ARDS induced by AP and evaluate the clinical value of NO in improving hypoxemia.

Read the detailed description

Aspiration pneumonia leading to acute respiratory distress syndrome (ARDS) is not uncommon in clinical practice, but sometimes it occurs covertly and is not easily detected by doctors or family members. Sometimes, acute respiratory failure occurs suddenly due to massive aspiration. Aspiration of gastric contents is the main cause of reflux aspiration, and there is also aspiration of pharyngeal secretions in patients with impaired swallowing function. Finding the cause of ARDS is of great significance for guiding treatment and determining prognosis, but currently there is limited research on aspiration pneumonia leading to ARDS, and there is a lack of effective biomarkers in clinical practice. Fiberoptic bronchoscopy is a commonly used examination and treatment method for ARDS patients. We hypothesize that the detection of pH or amylase in bronchoalveolar lavage fluid (BALF) may have diagnostic significance for reflux aspiration-induced ARDS. Changes in cell subgroups and cytokines in BALF are important for understanding the pathogenesis. Therefore, in our prospective study, we collected BALF from patients admitted to the ICU who underwent endotracheal intubation due to ARDS and required bronchoscopy examination. We tested the pH and amylase levels in the lavage fluid. We analyzed the causes of ARDS and compared the differences in pH and amylase levels in BALF between patients with reflux aspiration-induced ARDS and non-reflux aspiration-induced ARDS. In addition, we will also explore the changes in cells, cytokines, and omics differences in BALF of confirmed cases of reflux aspiration-induced ARDS to search for possible pathogenic mechanisms. This study's use of bronchoscopy examination is in line with patient treatment needs and will not increase patient suffering or burden. Informed consent will be obtained from all patients admitted to the ICU with ARDS before enrollment.

Recently, a retrospective analysis comparing the differences in amylase and pancreatic enzyme levels in BALF between aspiration pneumonia and non-aspiration pneumonia was published in Pulmonology. Based on the number of cases and ROC results, PASS (2021, v21.0.3) was used, requiring 22 cases (11 each) with a 20% dropout rate, resulting in 28 cases (14 each). In statistical analysis, data is presented as mean ± standard deviation or the interquartile range (IQR) of 25-75% as the median. F test was performed to compare the means of the two groups. Student's t-test and Welch's t-test were used to compare values with and without homogeneity, respectively. One-way analysis of variance was used for multiple comparisons. Mann-Whitney U test and Wilcoxon signed-rank test were used for comparing median values between independent variables and dependent variables. Kruskal-Wallis test was used for multiple comparisons. Receiver operating characteristic (ROC) curve analysis was used to evaluate the clinical effectiveness of BAL-amylase and BAL-pH, and chi-square test was used to examine their relationship with risk factors for aspiration-induced ARDS. Univariate and multivariate logistic regression analyses were performed to investigate the relationship between BAL-amylase or BAL-pH and ARDS, expressed as odds ratios (OR) with 95% confidence intervals (CI). All analyses were conducted using PASS.

EIT is often used in ARDS patients to assess ventilation function and titrate appropriate PEEP. In these patients, we perform EIT for ventilation-perfusion detection as clinically needed. This is a non-invasive procedure, while blood gas analysis is also essential for ARDS detection. For some patients, when judged by doctors and consented by family members, we administer nitric oxide (NO) inhalation therapy, and conduct follow-up EIT after NO inhalation according to the patient's condition changes. Therefore, for patients with AP-ARDS, we also monitor the changes in EIT ventilation-perfusion and record the blood gas changes and CT findings.

Being tested
aspiration, bronchial alveolar fluid, EIT V/Q test, Nitric oxide inhalation
Keywords
Aspiration Pneumonia, ARDS, cytokines, EIT
Medical subject headings
Respiratory Distress Syndrome, Pneumonia, Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aspirationBehavioural

    Also called AP

    Based on whether the patient meets the diagnosis of aspiration pneumonia.

  • bronchial alveolar fluidDiagnostic test

    Also called BAL

    Performing bronchoscopy.

  • EIT V/Q testDevice

    Local pulmonary ventilation and perfusion are measured by electrical impedance tomography (EIT). For perfusion imaging, 10 ml of 5% saline is injected as a central venous bolus. The matching of ventilation and perfusion reveals intrapulmonary shunting.

  • Nitric oxide inhalationOther

    According to the physician's judgment and the family members' consent, the patient is administered nitric oxide inhalation at a dosage of 20-30 parts per million (ppm).

Study groups in NCT06164639
Study groupRoleWhat they receive
Reflux aspiration groupReflux aspiration group
Receives: Behavioral: aspiration; Diagnostic Test: bronchial alveolar fluid; Device: EIT V/Q test; Other: Nitric oxide inhalation
Non-reflux aspiration groupNon-reflux aspiration group
Receives: Diagnostic Test: bronchial alveolar fluid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pepsin levels in BAL

    Performing detection of pepsin in BAL

    Measured: Submit for examination within 24 hours after each BAL acquisition.

Secondary outcomes (3)
  1. PH levels in BAL

    Performing detection of PH in BAL

    Measured: Submit for examination within 24 hours after each BAL acquisition.

  2. EIT V/Q

    Local pulmonary ventilation and perfusion are measured by electrical impedance tomography (EIT). For perfusion imaging, 10 ml of 5% saline is injected as a central venous bolus. The matching of ventilation and perfusion reveals intrapulmonary shunting.

    Measured: Submit for examination within 30min after BAL acquisition.

  3. P/F ratio

    Take the first blood gas after enrollment as the baseline, and record all blood gas values within 24 hours.

    Measured: All blood gas changes within 24 hours after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2023
  2. Study start28 Nov 2023
  3. Primary completion28 Nov 2025 (estimated)
  4. Study completion28 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
28 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06164639
Sponsor's protocol ID
ZSICU20231130
Status last verified
Dec 2024
First submitted
2 Dec 2023
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of ARDS, Human and Aspiration Pneumonia, run by Shanghai Zhongshan 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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 30 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?

This study is still under way. Results are not available in the source record yet.

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?

pepsin levels in BAL (time frame: Submit for examination within 24 hours after each BAL acquisition.). 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 30 Jul 2025.

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