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

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04730089
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Define the effect of epidural block on HPV by EIT.

Condition or Disease	Intervention/Treatment	Phase
Epidural Block; Electrical Impedance Tomography	Device: Electrical impedance tomography

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

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Epidural Block Impairs Hypoxic Pulmonary Vasoconstriction During One-lung Ventilation: an Electrical Impedance Tomography- Based Prospective Observation Study
• Actual Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Jul 31, 2022
• Anticipated Study Completion Date: Jul 31, 2022

Outcome Measures

Primary Outcome Measures

1. Assess regional distribution of pulmonary perfusion [within 24 hours]

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

2. Assess oxygenation status [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital of Fudan University	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ming Zhong, Professor, Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT04730089
• Other Study ID Numbers: EB-EIT
• First Posted: Jan 29, 2021
• Last Update Posted: Jan 29, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 29, 2021