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

NCT ID: NCT06195774

Last Updated: 2024-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Pregnancy Complications Atelectasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational cohort

Measure regional electric impedance of the lung for before and after insertion of an epidural analgesia catheter

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laszlo Szegedi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Erasmus University Hospital

Locations

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Erasmus University Hospital

Brussels, Anderlecht, Belgium

Site Status

Countries

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Belgium

Central Contacts

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Stefano Doria, M.D.

Role: CONTACT

025558354 ext. 58354

Alexandra Colesnicenco, M.D.

Role: CONTACT

025553919 ext. 53919

Other Identifiers

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SRB2023422

Identifier Type: -

Identifier Source: org_study_id

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