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

December 23, 2023 updated by: Erasme University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Anderlecht
      • Brussels, Anderlecht, Belgium, 1070
        • Erasmus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include healthy pregnant patients that come for spontaneous or induced labor at the hospital's delivery room.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observational cohort
Measure regional electric impedance of the lung for before and after insertion of an epidural analgesia catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional lung ventilation (ROI 1-4)
Time Frame: "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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Investigators

  • Principal Investigator: Laszlo Szegedi, M.D., Ph.D., Erasmus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 23, 2023

First Submitted That Met QC Criteria

December 23, 2023

First Posted (Estimated)

January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

December 23, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRB2023422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe