Epidural Block Impairs HPV During One-lung Ventilation: an EIT- Based Prospective Observation Study

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

Epidural Block Impairs Hypoxic Pulmonary Vasoconstriction During One-lung Ventilation: an Electrical Impedance Tomography- Based Prospective Observation Study

Define the effect of epidural block on HPV by EIT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Epidural block may affect the physiological mechanism of hypoxic pulmonary vasoconstriction, which is still poorly understood. Electrical impedance tomography might be helpful in establishing the hypoxemia etiology at bedside via combining regional ventilation and perfusion information.

Study Type

Observational

Enrollment (Anticipated)

50

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
        • Contact:
          • Yuxian Wang, BSc

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients requiring thoracic surgery are given combined epidural anesthesia.

Description

Inclusion Criteria:

  • Age 18 - 80 years Existing central venous and arterial access Chest circumference 70 - 150 cm

Exclusion Criteria:

  • Contraindication to central venous injection of 5 % sodium chloride (NaCl)

Contraindications of PulmoVista 500:

Patients with pacemakers, defibrillators or other electrically active implants Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings Patients where the attachment of the patient belt could pose a risk to the patient, e.g. patients with spinal lesions or fractures Patients with uncontrolled body movements Extremely obese patients (BMI>50) Patients during pregnancy Patients with massive lung edema Use during electricity-based therapies, such as electrosurgery or electrocautery Use in the presence of strong magnetic fields Use in conjunction with other bioimpedance measurement devices

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 epidural block on pulmonary blood flow distribution.
within 24 hours
Assess oxygenation status
Time Frame: within 24 hours
To evaluate the effect of epidural block 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

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)

August 1, 2020

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Actual)

January 29, 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

  • EB-EIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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