Pregnancy ComplicationsNCT06195774
Effect of Epidural Analgesia on Regional Lung Ventilation in Parturient Women as Assessed by Thoracic Impedance
An observational study of Pregnancy Complications and Atelectasis, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The goal of this observational study is to learn more about the effect of obstetric epidural anesthesia on regional lung ventilation in healthy parturient women. The main question it aims to answer is whether the initiation or epidural analgesia improves or not regional lung ventilation in healthy women at term during… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Complications, Atelectasis
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include healthy pregnant patients that come for spontaneous or induced labor at the hospital's delivery room.
Who may be able to join
- At-term pregnancy (at least 36 weeks)
- ASA class I-II
Who cannot join
- American Society of Anesthesiologists (ASA) Class III or more
- BMI>35 before pregnancy
- Contraindication to routinely administrated drugs (levobupivacaine, lidocaine, sufentanil)
- Contraindication to epidural analgesia
- Pregnancy-related complications (including pre-eclampsia)
- Respiratory system diseases
Show all 11Show fewer
- Severe psychiatric disorders
- Twin pregnancy
- Skin lesions in correspondence to the position of the Electric impedance tomography belt
- Pacemaker or Implantable Cardioverter Defibrillator (ICD)
- Language barrier
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact on Respiratory Function Associated to Epidural Analgesia in Parturient Women as Assessed by Electrical Impedance Tomography: a Monocentric Prospective Study
The goal of this observational study is to learn more about the effect of obstetric epidural anesthesia on regional lung ventilation in healthy parturient women. The main question it aims to answer is whether the initiation or epidural analgesia improves or not regional lung ventilation in healthy women at term during labor.
Participants will be subject to measurements of pulmonary impedance by electric impedance tomography before and after the start of epidural analgesia. No change will be applied to clinical care as a result of this measurement.
- Conditions
- Pregnancy Complications, Atelectasis
- Keywords
- pregnancy, labor, at term, electric impedance tomography, pulmonary impedance
- Medical subject headings
- Pregnancy Complications, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | Measure regional electric impedance of the lung for before and after insertion of an epidural analgesia catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional lung ventilation (ROI 1-4)
Assess regional ventilation as measured by electric impedance in each of the 4 Regions Of Interest (from anterior to posterior) in which the lung is divided, before and after epidural analgesia
Measured: "before" measurements will be taken just before applying lumbar epidural analgesia, and "after" measurements will be taken 5 minutes and ten minutes after starting lumbar epidural analgesia. Measurements take 10 minutes of continuous registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laszlo Szegedi, M.D., Ph.D., Principal investigator, Erasmus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195774
- Sponsor's protocol ID
- SRB2023422
- Status last verified
- Dec 2023
- First submitted
- 23 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Respiratory Function Associated to Epidural Analgesia in Parturient Women as Assessed by Electrical Impedance Tomography: a Monocentric Prospective Study
- ClinicalTrials.gov ID
- NCT06195774
- Acronym / sponsor ID
- SRB2023422
- Conditions
- Pregnancy Complications, Atelectasis
- Keywords
- pregnancy, labor, at term, electric impedance tomography, pulmonary impedance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jan 2024 (actual)
- 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.
The goal of this observational study is to learn more about the effect of obstetric epidural anesthesia on regional lung ventilation in healthy parturient women. The main question it aims to answer is whether the initiation or epidural analgesia improves or not regional lung ventilation in healthy women at term during labor.
Participants will be subject to measurements of pulmonary impedance by electric impedance tomography before and after the start of epidural analgesia. No change will be applied to clinical care as a result of this measurement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | –Measure regional electric impedance of the lung for before and after insertion of an epidural analgesia catheter |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include healthy pregnant patients that come for spontaneous or induced labor at the hospital's delivery room.
Key inclusion criteria (2 listed)
- At-term pregnancy (at least 36 weeks)
- ASA class I-II
Key exclusion criteria (11 listed)
- American Society of Anesthesiologists (ASA) Class III or more
- BMI>35 before pregnancy
- Contraindication to routinely administrated drugs (levobupivacaine, lidocaine, sufentanil)
- Contraindication to epidural analgesia
- Pregnancy-related complications (including pre-eclampsia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Regional lung ventilation (ROI 1-4)
Time frame: "before" measurements will be taken just before applying lumbar epidural analgesia, and "after" measurements will be taken 5 minutes and ten minutes after starting lumbar epidural analgesia. Measurements take 10 minutes of continuous registration
Assess regional ventilation as measured by electric impedance in each of the 4 Regions Of Interest (from anterior to posterior) in which the lung is divided, before and after epidural analgesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Laszlo Szegedi, M.D., Ph.D. principal investigator
Erasmus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Atelectasis, run by Erasme University Hospital 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 11 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: opening soon, as of the sponsor's last update on 8 Jan 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Doria, M.D. (025558354 ext. 58354, stefano.doria@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional lung ventilation (ROI 1-4) (time frame: "before" measurements will be taken just before applying lumbar epidural analgesia, and "after" measurements will be taken 5 minutes and ten minutes after starting lumbar epidural analgesia. Measurements take 10 minutes of continuous registration). 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 8 Jan 2024.