MedDataX Logo

Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia

NCT ID: NCT02523755

Last Updated: 2016-12-06

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

With an efficient epidural analgesia the physiological effects of pain are disabled during labor. Pain may cause an increase of minute volume, oxygen consumption and a decrease of paCO2 (Arterial CO2 pressure). The study will evaluate the lung function before and after labor with and without epidural analgesia. With more efficient breathing, the occurence of atelectasis should be reduced; this effect will be investigated in these settings for the first time with the electrical impedance tomography, which is a completely non-invasive measure.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The bedside efficacy of the electrical impedance tomography (EIT) in intensive care settings during mechanical ventilation is known. However, no studies demonstrate its utility during epidural analgesia for labor.

The purpose of this study is to evaluate lung function and atelectasis in pregnant women with or without epidural analgesia, during labor and after delivery.

Only adult consenting patients ASA I \& ASA II (American Society of Anaesthesiologists) are included in the study. According to institutional protocols lumbal epidural catheter is inserted and tested at the start of the labor, while patients' parameters are monitored.

Refusal to epidural analgesia, technical difficulties to insert the epidural catheter or any medical contraindication will result in inclusion of these patients in the control group.

Measurement with EIT is not invasive and harmful neither for the mother nor for the child.

It consists of putting a belt around the chest; this belt is linked to a monitor which measures the impedance of the different lung regions.

Electrical impedance measurements will be done for short periods of maximum 5 min. each as follows:

1. Placement before injection of local anesthetics through the epidural catheter in the study goup; in the control subset placement of the belt will be done when an epidural anesthetic would have been considered.
2. 1 hour after placement of the belt
3. 1 hour after delivery

These periods will be compared.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Atelectasis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

epidural analgesia for labor respiratory function electrical impedance tomography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Epidural analgesia Ropivacaine

Placement of an epidural catheter to achieve pain relief

Group Type ACTIVE_COMPARATOR

Epidural analgesia Ropivacaine

Intervention Type DRUG

Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics

Absence of epidural analgesia

Intervention Type DRUG

Measurement of regional distribution as assessed by EIT before and after delivery

Absence of epidural analgesia

No placement of an epidural catheter either because of patient refusal or contraindication

Group Type SHAM_COMPARATOR

Epidural analgesia Ropivacaine

Intervention Type DRUG

Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics

Absence of epidural analgesia

Intervention Type DRUG

Measurement of regional distribution as assessed by EIT before and after delivery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Epidural analgesia Ropivacaine

Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics

Intervention Type DRUG

Absence of epidural analgesia

Measurement of regional distribution as assessed by EIT before and after delivery

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ASA I
* ASA II

Exclusion Criteria

* Caesarian
* \< 18 years
* Expulsions
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Veerle Van Mossevelde

Data Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maxim Doutreluigne, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Laszlo L Szegedi, Prof.

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EIT

Identifier Type: -

Identifier Source: org_study_id