Electrical Impedance Tomography for Quantification of Pulmonary Edema in Acute Respiratory Distress Syndrome Patients

NCT ID: NCT02870894

Last Updated: 2016-08-18

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

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-08-31

Brief Summary

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

Evaluation of pulmonary edema is a key factor in monitoring and guidance of therapy in acute respiratory distress syndrome (ARDS) patients. To date, methods available at the bedside for estimating the physiologic correlate of pulmonary edema, extravascular lung water(EVLW), often are unreliable or require invasive measurements. The purpose of the this study is to develop a novel approach to reliably assess extravascular lung water by electrical impedance tomography(EIT).

Detailed Description

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

Conditions

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

Acute Respiratory Distress Syndrome

Study Design

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

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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

Inclusion Criteria

Patients will be included in this study if the following criteria have been met:

1. Males and females \> 18 years old and \<85 years old (non-pregnant, non-lactating females).
2. Patients fulfilled the Berlin diagnostic criteria of ARDS
3. Signed written informed consent has been obtained
4. Patients had monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)

Exclusion Criteria

1. Females who are pregnant or lactating.
2. Patients with contraindication of EIT(Skin abrasions or wounds in the chest area.Patients with pacemakers or paced EKG rhythms.Thoracic deformity. Severe subcutaneous emphysema)
3. Patients \<18 years old or \> 85 years old
4. Patients Without monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)
5. Patients with Cardiac function of grade 4 or patients with acute myocardial infarction or acute coronary syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Sichuan Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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

He Hongli

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Xiaobo Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Sichuan Academy of Medical Sciences

Locations

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

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, 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.

Hongli He, Ph.D

Role: CONTACT

+86-28-87393633

Facility Contacts

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

hongli He, Ph.D

Role: primary

+86-28-87393633

References

Explore related publications, articles, or registry entries linked to this study.

Zhao Z, He H, Luo J, Adler A, Zhang X, Liu R, Lan Y, Lu S, Luo X, Lei Y, Frerichs I, Huang X, Moller K. Detection of pulmonary oedema by electrical impedance tomography: validation of previously proposed approaches in a clinical setting. Physiol Meas. 2019 Jun 4;40(5):054008. doi: 10.1088/1361-6579/ab1d90.

Reference Type DERIVED
PMID: 31035265 (View on PubMed)

Other Identifiers

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

SichuanPPH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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