Effect of Epidural Analgesia on Regional Lung Ventilation... | NCT06195774

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

NCT06195774

Sponsor

Erasme University Hospital

Status

Not yet recruiting

Last Update Posted

Jan 8, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pregnancy Complications
Atelectasis

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2024Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Dec 23, 2023

First Submission Date that Met QC Criteria

Dec 23, 2023

First Posted Date

Jan 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2023

Last Update Posted Date

Jan 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational cohort		Measure regional electric impedance of the lung for before and after insertion of an epidural analgesia catheter

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Regional lung ventilation (ROI 1-4)	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	"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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study will include healthy pregnant patients that come for spontaneous or induced labor at the hospital's delivery room.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefano Doria, M.D.	Contact	025558354	58354	stefano.doria@hubruxelles.be
Alexandra Colesnicenco, M.D.	Contact	025553919	53919	a.colesnicenco@hubruxelles.be

Overall Officials

Name	Affiliation	Role
Laszlo Szegedi, M.D., Ph.D.	Erasmus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasmus University Hospital		Brussels	Anderlecht	1070	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011248	Pregnancy Complications
D001261	Pulmonary Atelectasis

Ancestor Terms

ID	Term
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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Browse Branches

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