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

Universitair Ziekenhuis Brussel

Status and phase: Completed; Phase 4

Conditions: Atelectasis; Pregnancy

Treatments: Drug: Absence of epidural analgesia; Drug: Epidural analgesia Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02523755

EIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I
• ASA II

Exclusion criteria

• Caesarian
• < 18 years
• Expulsions

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Epidural analgesia Ropivacaine

Active Comparator group

Description:

Placement of an epidural catheter to achieve pain relief

Treatment:

Drug: Absence of epidural analgesia

Drug: Epidural analgesia Ropivacaine

Absence of epidural analgesia

Sham Comparator group

Description:

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

Treatment:

Drug: Absence of epidural analgesia

Drug: Epidural analgesia Ropivacaine