Evaluation of Regional Distribution of Ventilation During... | NCT02523755

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

NCT02523755

Sponsor

Universitair Ziekenhuis Brussel

Status

Completed

Last Update Posted

Dec 6, 2016Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Pregnancy
Atelectasis

Interventions

Epidural analgesia Ropivacaine
Absence of epidural analgesia

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Nov 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jul 28, 2015

First Submission Date that Met QC Criteria

Aug 13, 2015

First Posted Date

Aug 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2016

Last Update Posted Date

Dec 6, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Veerle Van Mossevelde, Data Nurse, Universitair Ziekenhuis BrusselPrincipal Investigator

Lead Sponsor

Universitair Ziekenhuis BrusselOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epidural analgesia Ropivacaine	Active Comparator	Placement of an epidural catheter to achieve pain relief	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	Drug: Epidural analgesia Ropivacaine Drug: Absence of epidural analgesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epidural analgesia Ropivacaine	Drug	Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics	Absence of epidural analgesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Better lung function after labor with epidural analgesia	Using EIT we will map the degree of atelectasis	24h

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I
ASA II

Exclusion Criteria:

Caesarian
< 18 years
Expulsions

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maxim Doutreluigne, MD	Universitair Ziekenhuis Brussel	Principal Investigator
Laszlo L Szegedi, Prof.	Universitair Ziekenhuis Brussel	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitair Ziekenhuis Brussel		Jette	Vlaams Brabant	1090	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

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