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NCT Number: NCT02523755

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

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.

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Key information

Conditions

Pregnancy Atelectasis Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Atelectasis Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I
  • ASA II

Exclusion criteria

  • Caesarian
  • < 18 years
  • Expulsions

Treatment and study plan

Epidural analgesia Ropivacaine

Drug

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

Absence of epidural analgesia

Drug

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

Primary outcomes

  1. Better lung function after labor with epidural analgesia

    Time frame: 24h

    Using EIT we will map the degree of atelectasis

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2015
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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