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

NCT06164639 | Enrolling By Invitation

• 1 other identifier: ZSICU20231130
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ARDS, Human; Aspiration Pneumonia

Keywords

Aspiration Pneumonia; ARDS; cytokines; EIT

Outcome Measures

Primary Outcomes (1)

• pepsin levels in BAL

  Performing detection of pepsin in BAL

  Submit for examination within 24 hours after each BAL acquisition.

Secondary Outcomes (3)

• PH levels in BAL

  Submit for examination within 24 hours after each BAL acquisition.

• EIT V/Q

  Submit for examination within 30min after BAL acquisition.

• P/F ratio

  All blood gas changes within 24 hours after enrollment

Study Arms (2)

Reflux aspiration group

Reflux aspiration group

Behavioral: aspiration; Diagnostic Test: bronchial alveolar fluid; Device: EIT V/Q test; Other: Nitric oxide inhalation

Non-reflux aspiration group

Non-reflux aspiration group

Diagnostic Test: bronchial alveolar fluid

Interventions

aspiration BEHAVIORAL

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

Also known as: AP

Reflux aspiration group

bronchial alveolar fluid DIAGNOSTIC_TEST

Performing bronchoscopy.

Also known as: BAL

Non-reflux aspiration group; Reflux aspiration group

EIT V/Q test DEVICE

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.

Reflux aspiration group

Nitric oxide inhalation OTHER

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).

Reflux aspiration group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The collected bronchoalveolar lavage fluid contains cellular components. We will centrifuge and separate the cells and supernatant. The supernatant will be used to detect biomarkers, while the cells will be used for sequencing analysis to explore the underlying mechanisms for further study.

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia; Respiratory Tract Infections; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 11, 2023
• Study Start: November 28, 2023
• Primary Completion: November 28, 2025
• Study Completion (Estimated): November 28, 2026
• Last Updated: July 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)