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

NCT02870894 | Unknown DMC

• 1 other identifier: SichuanPPH
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Comparison between a novel EIT-based method to estimate pulmonary edema (lung water ratio-EIT ) with a conventional measurement for EVLW using trans-cardiopulmonary thermodilution technique

  once the patient was consented and enrolled

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult ICU patients with ARDS will be enrolled between August 2016 and August 2017 when they fulfilled the inclusion criteria,and unfulfilled the exclusion criteria below

You may qualify if:

• Patients will be included in this study if the following criteria have been met:
• Males and females \> 18 years old and \<85 years old (non-pregnant, non-lactating females).
• Patients fulfilled the Berlin diagnostic criteria of ARDS
• Signed written informed consent has been obtained
• Patients had monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)

You may not qualify if:

• Females who are pregnant or lactating.
• 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)
• Patients \<18 years old or \> 85 years old
• Patients Without monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)
• Patients with Cardiac function of grade 4 or patients with acute myocardial infarction or acute coronary syndrome

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

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

Chengdu, Sichuan, 610072, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31035265 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Xiaobo Huang, MD

  Sichuan Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongli He, Ph.D

CONTACT

+86-28-87393633; doctorhhl2016@126.com

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2016
• First Posted: August 17, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 18, 2016

Record last verified: 2016-08

Locations

CN (1)