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The aim of the study is to assess if there is a difference in ability to thread the epidural catheter from two different epidural pain management kits vendors
The aim of the study is to assess if there is a difference in ability to thread the epidural catheter from two different pain management kits. In order to improve patient care, if there is a difference in the time to thread epidurals with one kit over the other, we would like to use the kit with decreased time to thread in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arrow Catheter Kit. | Other | Arrow FlexTip Plus Epidural Catheterization Kit is a single orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks. |
|
| B.Braun Catheter Kit | Other | Perifix FX Springwound Epidural Catheter Kit is a multi-orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arrow Catheter Kit. | Device | The group will be randomized to receive this labor analgesia kit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Successful Thread at First Pass | A thread is considered successful at first pass if there were no minor or major manipulations required. | within 60min of first attempt at placement |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Thread Epidural Catheter | At the epidural placement, total amount of time required to establish successful epidural catheter thread | within 60min of first attempt at placement |
| Incidence of Unintended Dural Punctures |
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Inclusion Criteria: women in labor
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Pancaro, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| von Voitlander Women's Hospital | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33835077 | Derived | Pancaro C, Purtell J, LaBuda D, Saager L, Klumpner TT, Dubovoy T, Rajala B, Singh S, Cassidy R, Vahabzadeh C, Maxwell S, Manica V, Eckmann DM, Mhyre JM, Engoren MC. Difficulty in Advancing Flexible Epidural Catheters When Establishing Labor Analgesia: An Observational Open-Label Randomized Trial. Anesth Analg. 2021 Jul 1;133(1):151-159. doi: 10.1213/ANE.0000000000005526. |
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1 year
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Participants were excluded if there was a fetal loss involved.
Patients in labor requesting epidural analgesia for an expected vaginal delivery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arrow Catheter Kit. | Arrow FlexTip Plus Epidural Catheterization Kit is a single orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks. Arrow Catheter Kit.: The group will be randomized to receive this labor analgesia kit. |
| FG001 | B.Braun Catheter Kit | Perifix FX Springwound Epidural Catheter Kit is a multi-orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks. B.Braun Catheter Kit: The group will be randomized to receive this labor analgesia kit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arrow Catheter Kit. | Arrow FlexTip Plus Epidural Catheterization Kit is a single orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks. Arrow Catheter Kit.: The group will be randomized to receive this labor analgesia kit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced a Successful Thread at First Pass | A thread is considered successful at first pass if there were no minor or major manipulations required. | Posted | Count of Participants | Participants | within 60min of first attempt at placement |
|
Within 60 minutes of first attempt at placement
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arrow Catheter Kit. | Arrow FlexTip Plus Epidural Catheterization Kit is a single orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks. Arrow Catheter Kit.: The group will be randomized to receive this labor analgesia kit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlo Pancaro | University of Michigan - Department of Anesthesiology | 617-435-5403 | cpancaro@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2018 | Sep 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| B.Braun Catheter Kit | Device | The group will be randomized to receive this labor analgesia kit. |
|
Count of participants for whom there was an unintended dural puncture after placement
| within 60min of first attempt at placement |
| Incidence of Paresthesia | Count of participants for whom there was an incidence of paresthesia | within 60min of first attempt at placement |
| Incidence of Epidural Intravascular Cannulations | Count of participants for whom there was an incidence of epidural intravascular cannulation | within 60min of first attempt at placement |
| Epidural Needle Manipulations Needed to Successfully Advance | For each participant, the number of total manipulations (major or minor) needed to successfully advance catheter | within 60min of first attempt at placement |
| BG001 |
| B.Braun Catheter Kit |
Perifix FX Springwound Epidural Catheter Kit is a multi-orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks. B.Braun Catheter Kit: The group will be randomized to receive this labor analgesia kit. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Gestational Age | Mean | Standard Deviation | weeks |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
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| Cervical Dilation | Mean | Standard Deviation | cm |
|
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|
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| Secondary | Time to Thread Epidural Catheter | At the epidural placement, total amount of time required to establish successful epidural catheter thread | Posted | Mean | Standard Deviation | seconds | within 60min of first attempt at placement |
|
|
|
|
| Secondary | Incidence of Unintended Dural Punctures | Count of participants for whom there was an unintended dural puncture after placement | Posted | Count of Participants | Participants | within 60min of first attempt at placement |
|
|
|
|
| Secondary | Incidence of Paresthesia | Count of participants for whom there was an incidence of paresthesia | Posted | Count of Participants | Participants | within 60min of first attempt at placement |
|
|
|
|
| Secondary | Incidence of Epidural Intravascular Cannulations | Count of participants for whom there was an incidence of epidural intravascular cannulation | Posted | Count of Participants | Participants | within 60min of first attempt at placement |
|
|
|
|
| Secondary | Epidural Needle Manipulations Needed to Successfully Advance | For each participant, the number of total manipulations (major or minor) needed to successfully advance catheter | Posted | Count of Participants | Participants | within 60min of first attempt at placement |
|
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
| EG001 | B.Braun Catheter Kit | Perifix FX Springwound Epidural Catheter Kit is a multi-orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks. B.Braun Catheter Kit: The group will be randomized to receive this labor analgesia kit. | 0 | 120 | 0 | 120 | 0 | 120 |
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| 2 manipulations |
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| 3 manipulations |
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| 4 manipulations |
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| 5 manipulations |
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| 6 manipulations |
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