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

Acute Respiratory Distress Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02870894
• Other study ID #: SichuanPPH
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2016
• Last updated: August 17, 2016
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2016
• Source: Sichuan Provincial People's Hospital
• Contact: Hongli He, Ph.D
• Phone: +86-28-87393633
• Email: doctorhhl2016[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
China	Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Cheng Du	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No