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

Electrical Impedance Tomography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04730089
• Other study ID #: EB-EIT
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: January 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Ming Zhong, MD, phD
• Phone: 021-65642662
• Email: zhong.ming[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Define the effect of epidural block on HPV by EIT.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Electrical Impedance Tomography
• Epidural Block

Intervention

Device:
• Electrical impedance tomography
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).

Locations

Country	Name	City	State
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess regional distribution of pulmonary perfusion	To evaluate the effect of epidural block on pulmonary blood flow distribution.	within 24 hours
Primary	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