Effect of Epidural Analgesia on Regional Lung Ventilation in Parturient Women as Assessed by Thoracic Impedance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnancy Complications, Atelectasis. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact on Respiratory Function Associated to Epidural Analgesia in Parturient Women as Assessed by Electrical Impedance Tomography: a Monocentric Prospective Study
Overview
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.
Primary outcome measures
- 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]
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)
- Language barrier
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 1 center
- Erasmus University Hospital — Brussels
Identifiers
NCT: NCT06195774 · SRB2023422