Epidural BlockNCT04730089
Epidural Block Impairs HPV During One-lung Ventilation: an EIT- Based Prospective Observation Study
An observational study of Epidural Block and Electrical Impedance Tomography, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Define the effect of epidural block on HPV by EIT. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Epidural Block, Electrical Impedance Tomography
- What is being tested?
- Electrical impedance tomography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Jul 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring thoracic surgery are given combined epidural anesthesia.
Who may be able to join
- Age 18 - 80 years Existing central venous and arterial access Chest circumference 70 - 150 cm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Ming Zhong, MD, phD
Yuxian Wang, BSc
About this study
Official title: 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.
Read the 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.
- Conditions
- Epidural Block, Electrical Impedance Tomography
- Being tested
- Electrical impedance tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomographyDevice
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess regional distribution of pulmonary perfusion
To evaluate the effect of epidural block on pulmonary blood flow distribution.
Measured: 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.
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Aug 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidural BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Zhong, Shanghai Zhongshan Hospital
- Investigators
- Ming Zhong, MD, phD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730089
- Sponsor's protocol ID
- EB-EIT
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39504921
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Block Impairs Hypoxic Pulmonary Vasoconstriction During One-lung Ventilation: an Electrical Impedance Tomography- Based Prospective Observation Study
- ClinicalTrials.gov ID
- NCT04730089
- Acronym / sponsor ID
- EB-EIT
- Conditions
- Epidural Block, Electrical Impedance Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Define the effect of epidural block on HPV by EIT.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring thoracic surgery are given combined epidural anesthesia.
Key inclusion criteria (1 listed)
- Age 18 - 80 years Existing central venous and arterial access Chest circumference 70 - 150 cm
Key exclusion criteria (3 listed)
- Contraindication to central venous injection of 5 % sodium chloride (NaCl)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical impedance tomographyA 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). | Device | – |
Primary outcome
Assess regional distribution of pulmonary perfusion
Time frame: within 24 hours
To evaluate the effect of epidural block on pulmonary blood flow distribution.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Derived from this study: PubMed 39504921Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Zhong, MD, phD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidural Block and Electrical Impedance Tomography, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Zhong, MD, phD (021-65642662, zhong.ming@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess regional distribution of pulmonary perfusion (time frame: within 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04730089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021; AzTrials last refreshed its copy on 27 Oct 2026.