Clinical Empirical Research of ARDS

June 27, 2023 updated by: wang kaifei, Chinese PLA General Hospital
According to the ARDS Berlin definition, patients with severe concurrent invasive mechanical ventilation were selected, and clinical data and prognosis were collected. Samples such as blood and balf were collected for analysis based on changes in the condition.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
        • Contact:
          • lixin xie, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

According to the ARDS Berlin definition, patients with severe concurrent invasive mechanical ventilation were selected, and clinical data and prognosis were collected. Samples such as blood and balf were collected for analysis based on changes in the condition.

Description

Inclusion Criteria:

  1. Patients who meet the Berlin definition of ARDS and require invasive mechanical ventilation. ARDS diagnostic criteria: according to the Berlin definition, Chest radiograph shows patchy shadows in the lungs; Respiratory failure cannot be completely caused by heart failure or excessive fluid infusion
  2. ARDS onset ≤ 3 days when included in the study
  3. Patient PaO2/FiO2 ≤ 200mmHg when included in the study

Exclusion Criteria:

  • 1) Patients with intracranial hypertension, pleural fistula, pneumothorax, HIV, HBV, HCV

    2) Age>85 years old or<18 years old

    3) Pregnant patients

    4) Severe hemodynamic instability (vasopressor increase>30% in the first 6 hours, or Norepinephrine>0.5 mg kg/min)

    5) Patients unable to perform EIT ventilation and/or perfusion testing (unable to perform internal jugular vein catheterization, Hypernatremia, chest malformation, active implant device, unstable spinal injury or fracture, skin lesions opposite the EIT monitoring area)

    6) Patients with abnormal esophageal anatomical structure and inability to indwelling gastric tubes

    7) Disagreement for inclusion in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 18, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ARDS Research

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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