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

Not yet recruiting

• Conditions: Pregnancy Complications; Atelectasis

• Registration Number: NCT06195774
• Lead Sponsor: Erasme University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-23
• Study First Submitted QC: 2023-12-23
• Last Update Submitted: 2023-12-23
• Study Start: 2024-01
• Study First Posted: 2024-01-08
• Last Update Posted: 2024-01-08
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Regional lung ventilation (ROI 1-4)	"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

Trial Locations

Locations (1)

Erasmus University Hospital; 🇧🇪 Brussels, Anderlecht, Belgium