Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06195774

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pregnancy Complications Atelectasis Female Urogenital Diseases and Pregnancy Complications Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Erasmus University Hospital

Brussels, Anderlecht, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Colesnicenco, M.D.

CONTACT

[email protected]

025553919 ext. 53919

Stefano Doria, M.D.

CONTACT

[email protected]

025558354 ext. 58354

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 8, 2024
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.