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

Primary Purpose

Pregnancy, Atelectasis

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Epidural analgesia Ropivacaine
Absence of epidural analgesia
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pregnancy focused on measuring epidural analgesia for labor, respiratory function, electrical impedance tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I
  • ASA II

Exclusion Criteria:

  • Caesarian
  • < 18 years
  • Expulsions

Sites / Locations

  • Universitair Ziekenhuis Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Epidural analgesia Ropivacaine

Absence of epidural analgesia

Arm Description

Placement of an epidural catheter to achieve pain relief

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

Outcomes

Primary Outcome Measures

Better lung function after labor with epidural analgesia
Using EIT we will map the degree of atelectasis

Secondary Outcome Measures

Full Information

First Posted
July 28, 2015
Last Updated
December 5, 2016
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT02523755
Brief Title
Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia
Official Title
Evaluation of Regional Distribution of Ventilation in Spontaneous Breathing Patients During Labor With or Without Epidural Analgesia Using EIT (Electrical Impedance Tomography)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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: 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. 1 hour after placement of the belt 1 hour after delivery These periods will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Atelectasis
Keywords
epidural analgesia for labor, respiratory function, electrical impedance tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural analgesia Ropivacaine
Arm Type
Active Comparator
Arm Description
Placement of an epidural catheter to achieve pain relief
Arm Title
Absence of epidural analgesia
Arm Type
Sham Comparator
Arm Description
No placement of an epidural catheter either because of patient refusal or contraindication
Intervention Type
Drug
Intervention Name(s)
Epidural analgesia Ropivacaine
Intervention Description
Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics
Intervention Type
Drug
Intervention Name(s)
Absence of epidural analgesia
Intervention Description
Measurement of regional distribution as assessed by EIT before and after delivery
Primary Outcome Measure Information:
Title
Better lung function after labor with epidural analgesia
Description
Using EIT we will map the degree of atelectasis
Time Frame
24h

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I ASA II Exclusion Criteria: Caesarian < 18 years Expulsions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxim Doutreluigne, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laszlo L Szegedi, Prof.
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Chair
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Vlaams Brabant
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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