Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients

NCT ID: NCT03763890

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2023-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

ARDS(Acute respiratory distress syndrome )is common in patients suffering Sepsis, trauma, burning and other sever condition and characterized by diffuse alveolar damage and alveolar heterogeneity.ARDS patient need MV(mechanical ventilation )to maintain oxygenation and need unique MV tragedy to avoid VILI(Ventilator induced Lung injury ).PEEP(post-end-expiratory pressure) is crucial to maintain oxygenation and avoid VILI according to researches. But there are also some other research different voice. This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ards

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Post-end-Expiratory pressure

Titrate the PEEP from 24 cmH2O to 6 cmH2O, 2 cmH2O/step and record EIT, trans-pulmonary pressure, hemodynamic parameter and Blood-gas analysis.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age≥18 or\<80;
2. Moderate or sever ARDS in 2012 \<Berlin definition\>;
3. Applied mechanical ventilation;
4. Consent signed.

Exclusion Criteria

1. Asthma or COPD;
2. Cardiogenic edema;
3. Sever neutropenia(\<500/mm3);
4. Hemodynamic astatic: DOPA or Dobutamine \>15 µg/kg/ min; NE \> 15ug /min;
5. GCS coma score ≤12;
6. Thoracic injury or surgery patients contradict EIT ;
7. Refuse to join in trail;
8. Included in other clinical trail。
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ling Liu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

haibo qiu, PhD

Role: STUDY_DIRECTOR

Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nanjing Zhong-Da Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

ling Liu, Phd

Role: CONTACT

13851435472

haibo qiu, PhD

Role: CONTACT

13951965301 ext. professor

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ling Liu, MD.

Role: primary

86-25-83272201

Haibo Qiu, PhD.,MD.

Role: backup

86-25-83272200

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20181129PEEP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lung EIT Image Guide Ventilation in ARDS
NCT07309783 NOT_YET_RECRUITING NA