NCT04730089

Brief Summary

Define the effect of epidural block on HPV by EIT.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 25, 2021

Last Update Submit

January 25, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Assess regional distribution of pulmonary perfusion

    To evaluate the effect of epidural block on pulmonary blood flow distribution.

    within 24 hours

  • Assess oxygenation status

    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

Interventions

A bolus of 10ml 10% NaCl was injected during a respiratory pause (≥10s) through the central venous catheter.The results of arterial blood gas analysis and the data of EIT were collected before the first prone session (time baseline), the end of prone positioning (time P).

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring thoracic surgery are given combined epidural anesthesia.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • Wang Y, Wei Y, Chen G, Wang Z, Fan Y, Wang J, Yang Y, Zhou D, Zhong M. The effects of thoracic epidural blockade on ventilation-perfusion matching during one-lung ventilation: An exploratory study. J Clin Anesth. 2024 Dec;99:111678. doi: 10.1016/j.jclinane.2024.111678. Epub 2024 Nov 6.

Study Officials

  • Ming Zhong, MD, phD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 29, 2021

Study Start

August 1, 2020

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations