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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)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02523755
Enrollment
40
Registered
2015-08-14
Start date
2015-09-30
Completion date
2016-12-31
Last updated
2016-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atelectasis, Pregnancy

Keywords

epidural analgesia for labor, respiratory function, electrical impedance tomography

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: 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.

Interventions

DRUGEpidural analgesia Ropivacaine

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

DRUGAbsence of epidural analgesia

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

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ASA I * ASA II

Exclusion criteria

* Caesarian * \< 18 years * Expulsions

Design outcomes

Primary

MeasureTime frameDescription
Better lung function after labor with epidural analgesia24hUsing EIT we will map the degree of atelectasis

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026