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NCT06195774 Clinical Trial

Effect of Epidural Analgesia on Regional Lung Ventilation in Parturient Women as Assessed by Thoracic Impedance

Pregnancy Complications Clinical Trial

Official title:
Impact on Respiratory Function Associated to Epidural Analgesia in Parturient Women as Assessed by Electrical Impedance Tomography: a Monocentric Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06195774
Other study ID # SRB2023422
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2024
Est. completion date December 2026

Study information
Verified date December 2023
Source Erasme University Hospital
Contact Stefano Doria, M.D.
Phone 025558354
Email stefano.doria@hubruxelles.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to learn more about the effect of obstetric epidural anesthesia on regional lung ventilation in healthy parturient women. The main question it aims to answer is whether the initiation or epidural analgesia improves or not regional lung ventilation in healthy women at term during labor. Participants will be subject to measurements of pulmonary impedance by electric impedance tomography before and after the start of epidural analgesia. No change will be applied to clinical care as a result of this measurement.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - At-term pregnancy (at least 36 weeks) - ASA class I-II Exclusion Criteria: - American Society of Anesthesiologists (ASA) Class III or more - BMI>35 before pregnancy - Contraindication to routinely administrated drugs (levobupivacaine, lidocaine, sufentanil) - Contraindication to epidural analgesia - Pregnancy-related complications (including pre-eclampsia) - Respiratory system diseases - Severe psychiatric disorders - Twin pregnancy - Skin lesions in correspondence to the position of the Electric impedance tomography belt - Pacemaker or Implantable Cardioverter Defibrillator (ICD) - Language barrier

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Erasmus University Hospital Brussels Anderlecht

Sponsors (1)
Lead Sponsor Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Regional lung ventilation (ROI 1-4) Assess regional ventilation as measured by electric impedance in each of the 4 Regions Of Interest (from anterior to posterior) in which the lung is divided, before and after epidural analgesia "before" measurements will be taken just before applying lumbar epidural analgesia, and "after" measurements will be taken 5 minutes and ten minutes after starting lumbar epidural analgesia. Measurements take 10 minutes of continuous registration
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