Determine the Effect of Prone Positioning in Adults With ARDS by Electrical Impedance Tomography

January 25, 2021 updated by: Ming Zhong, Shanghai Zhongshan Hospital

Determine the Effect of Prone Positioning on Lung Ventilation and Perfusion Distribution in Adults With Acute Respiratory Distress Syndrome by Electrical Impedance Tomography

determine the effect of prone positioning on ventilation and perfusion distribution in adults with acute respiratory distress syndrome by electrical impedance tomography

Study Overview

Status

Recruiting

Conditions

Detailed Description

By intravenous injection of a small amount of normal saline, electrical impedance tomography enables evaluation of the pulmonary blood flow. EIT might be helpful in establishing the hypoxemia etiology at bedside via combining regional ventilation and perfusion information. The objective of this study was to describe the physiological effects of prone position on respiratory mechanics, ventilation and pulmonary perfusion in patients with ARDS.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital of Fudan University
        • Contact:
          • Ming Zhong, MD, phD

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients requiring mechanical ventilation are recieved prone position ventilation who admitted to the surgical ICU.

Description

Inclusion Criteria:

  • patients who were undergoing mechanical ventilation with moderate-to-severe ARDS (defined as a Pao2:Fio2 ratio < 150 mm Hg with a positive end-expiratory pressure ≥ 5 cm of water, and an Fio2 of ≥ 0.6) according to the Berlin definition

Exclusion Criteria:

  • contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing)

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess regional distribution of pulmonary perfusion
Time Frame: within 24 hours
To evaluate the effect of prone positon on pulmonary blood flow distribution.
within 24 hours
Assess regional distribution of pulmonary ventilation
Time Frame: within 24 hours
To evaluate the effect of prone positon on pulmonary vetilation distribution.
within 24 hours
Assess oxygenation status
Time Frame: within 24 hours
To evaluate the effect of prone position by assessing regional distribution of pulmonary perfusion based on indicator dilution and changes at different points in time during varying states of regional ventilation will be evaluated.
within 24 hours

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Ming Zhong, MD, phD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • P-E

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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