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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523755
• Other study ID #: EIT
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2015
• Last updated: December 5, 2016
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA I

• ASA II

Exclusion Criteria:

• Caesarian

• < 18 years

• Expulsions

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atelectasis
• Pregnancy
• Pulmonary Atelectasis

Intervention

Drug:
• Epidural analgesia Ropivacaine
Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics
• Absence of epidural analgesia
Measurement of regional distribution as assessed by EIT before and after delivery

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Better lung function after labor with epidural analgesia	Using EIT we will map the degree of atelectasis	24h	Yes