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

Evaluation of Regional Distribution of Ventilation in Spontaneous Breathing Patients During Labor With or Without Epidural Analgesia Using EIT (Electrical Impedance Tomography)

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Atelectasis
• Intervention / Treatment: Drug: Epidural analgesia Ropivacaine; Drug: Absence of epidural analgesia

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:

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Jette, Vlaams Brabant, Belgium, 1090
      • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA I
• ASA II

Exclusion Criteria:

• Caesarian
• < 18 years
• Expulsions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural analgesia Ropivacaine; Placement of an epidural catheter to achieve pain relief	Drug: Epidural analgesia Ropivacaine; Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics; Drug: Absence of epidural analgesia; Measurement of regional distribution as assessed by EIT before and after delivery
Sham Comparator: Absence of epidural analgesia; No placement of an epidural catheter either because of patient refusal or contraindication	Drug: Epidural analgesia Ropivacaine; Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics; Drug: Absence of epidural analgesia; Measurement of regional distribution as assessed by EIT before and after delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Better lung function after labor with epidural analgesia	Using EIT we will map the degree of atelectasis	24h

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Maxim Doutreluigne, MD, Universitair Ziekenhuis Brussel; Study Chair: Laszlo L Szegedi, Prof., Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: electrical impedance tomography; respiratory function; epidural analgesia for labor
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: EIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO