PregnancyPhase 4NCT02523755
Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia
A Phase 4 study testing Epidural analgesia Ropivacaine and Absence of epidural analgesia in people with Pregnancy and Atelectasis, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Atelectasis
- What is being tested?
- Epidural analgesia Ropivacaine and Absence of epidural analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I
- ASA II
Who cannot join
- Caesarian
- < 18 years
- Expulsions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Pregnancy, Atelectasis
- Being tested
- Epidural analgesia Ropivacaine, Absence of epidural analgesia
- Keywords
- epidural analgesia for labor, respiratory function, electrical impedance tomography
- Medical subject headings
- Pulmonary Atelectasis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesia RopivacaineDrug
Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics
Absence of epidural analgesiaDrug
Measurement of regional distribution as assessed by EIT before and after delivery
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia Ropivacaine | Active comparator | Placement of an epidural catheter to achieve pain relief Receives: Drug: Epidural analgesia Ropivacaine; Drug: Absence of epidural analgesia |
| Absence of epidural analgesia | Sham comparator | No placement of an epidural catheter either because of patient refusal or contraindication Receives: Drug: Epidural analgesia Ropivacaine; Drug: Absence of epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Better lung function after labor with epidural analgesia
Using EIT we will map the degree of atelectasis
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Maxim Doutreluigne, MD, Principal investigator, Universitair Ziekenhuis BrusselLaszlo L Szegedi, Prof., Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523755
- Sponsor's protocol ID
- EIT
- Status last verified
- Dec 2016
- First submitted
- 28 Jul 2015
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regional Distribution of Ventilation in Spontaneous Breathing Patients During Labor With or Without Epidural Analgesia Using EIT (Electrical Impedance Tomography)
- ClinicalTrials.gov ID
- NCT02523755
- Acronym / sponsor ID
- EIT
- Conditions
- Pregnancy, Atelectasis
- Keywords
- epidural analgesia for labor, respiratory function, electrical impedance tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia Ropivacaine | Active comparator | Drug: Epidural analgesia Ropivacaine, Drug: Absence of epidural analgesiaPlacement of an epidural catheter to achieve pain relief |
| Absence of epidural analgesia | Sham comparator | Drug: Epidural analgesia Ropivacaine, Drug: Absence of epidural analgesiaNo placement of an epidural catheter either because of patient refusal or contraindication |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I
- ASA II
Key exclusion criteria (3 listed)
- Caesarian
- < 18 years
- Expulsions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural analgesia RopivacaineMeasurement of regional distribution as assessed by EIT before and after injection of local anesthetics | Drug | Absence of epidural analgesia, Epidural analgesia Ropivacaine |
| Absence of epidural analgesiaMeasurement of regional distribution as assessed by EIT before and after delivery | Drug | Absence of epidural analgesia, Epidural analgesia Ropivacaine |
Primary outcome
Better lung function after labor with epidural analgesia
Time frame: 24h
Using EIT we will map the degree of atelectasis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxim Doutreluigne, MD principal investigator
Universitair Ziekenhuis Brussel
Laszlo L Szegedi, Prof. study chair
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epidural analgesia Ropivacaine and Absence of epidural analgesia in people with Pregnancy and Atelectasis, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Better lung function after labor with epidural analgesia (time frame: 24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.