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Clinical Trials/NCT06195774
NCT06195774
Not Yet Recruiting
N/A

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

Erasme University Hospital1 site in 1 country100 target enrollmentJanuary 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pregnancy Complications
Sponsor
Erasme University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Regional lung ventilation (ROI 1-4)
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2024
End Date
December 2026
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Erasme University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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 Sites (1)

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