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The objective of the study is to verify the efficacies of both air and saline based procedure of EpiFaith syringe for assisting the needle localization of the epidural space.
This is a single blind, randomized study. Subjects who will receive a surgery requiring epidural anesthesia or analgesia and meet all of the study criteria will be enrolled in the study. All subjects must sign an informed consent and receive a copy of the signed and dated informed consent form prior to participation in the trial.
The study consists of 2 study visits: Visit 1 (Screening Visit) and Visit 2 (Operative Visit). After screening, eligible subject will be randomly assigned to one of the following groups: Group A: detection by EpiFaith syringe with air; Group S: detection by EpiFaith syringe with saline with a 1:1 ratio. In Visit 2, the following variables will be recorded and rated during the process of epidural space localization: Success of epidural localization, time to identify the epidural space, duration of the epidural space localization procedure, number of attempts, Number of the occurrence of false positive, the distance from the skin to the epidural space, and number of change insertion segment. Adverse events and concomitant treatments will be also recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Detection by EpiFaith syringe with air | Experimental | Fill the EpiFaith Syringe with air for LOR detection |
|
| Detection by EpiFaith syringe with saline | Experimental | Fill the EpiFaith Syringe with saline for LOR detection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EpiFaith loss of resistance detect syringe | Device | An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of Epidural Localization | Defined as the catheter can be inserted into epidural space successfully, no cold perception in the blocked dermatomes after the injection of anesthetic by cold sensation test, and no occurrence of inadvertent dural puncture. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The Time to Identify the Epidural Space | Defined as the time of the successful localization from the first syringe attached to the Tuohy needle to the occurrence of LOR signal. | 30 minutes |
| Duration of the Epidural Space Localization Procedure |
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Inclusion Criteria:
Exclusion Criteria:
Bleeding and clotting disorders
History of peripheral neuropathy
Neuromuscular or neuropsychiatric disease
Marked spinal deformities or a history of spinal instrumentation
Systemic infection
Skin infection at the injection site
Significant heart failure, e.g. New York Heart Association (NYHA) Functional Classification 3 or 4
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| Name | Affiliation | Role |
|---|---|---|
| Chien-Kun Ting, MD | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Please Select | 11217 | Taiwan |
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Subjects will be randomized to one of the two groups (A group - EpiFaith syringe with air or S group - EpiFaith syringe with saline) at the ratio of 1:1. The randomization method will result in sealed, opaque envelopes containing the computer- generated, random assignment. Randomization will occur in blocks so that blocks of equal numbers of subjects will be used to avoid potential runs of assignments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Detection by EpiFaith Syringe With Air | Fill the EpiFaith Syringe with air for LOR detection |
| FG001 | Detection by EpiFaith Syringe With Saline | Fill the EpiFaith Syringe with saline for LOR detection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Detection by EpiFaith Syringe With Air | Fill the EpiFaith Syringe with air for LOR detection |
| BG001 | Detection by EpiFaith Syringe With Saline | Fill the EpiFaith Syringe with saline for LOR detection |
| 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 | Success of Epidural Localization | Defined as the catheter can be inserted into epidural space successfully, no cold perception in the blocked dermatomes after the injection of anesthetic by cold sensation test, and no occurrence of inadvertent dural puncture. | Posted | Count of Participants | Participants | 30 minutes |
|
1 day
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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 | Detection by EpiFaith Syringe With Air | Fill the EpiFaith Syringe with air for LOR detection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| LI YU LIN | Flat Medical Co., Ltd | +886 25672959 | 16 | liyulin@flatmedical.com |
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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 | Mar 15, 2019 | Aug 16, 2021 | Prot_SAP_000.pdf |
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Defined as the time from the puncture of skin to the successful insertion of the epidural catheter.
| 30 minutes |
| Number of Attempts | Defined as the insertion of the epidural catheter is unsuccessful or the perception of cold exists in the blocked dermatomes after the injection of anesthetic by cold sensation test. | 30 minutes |
| The Distance From the Skin to the Epidural Space | Defined as the insertion distance of the needle after locating the epidural space. | 30 minutes |
| Number of Change Insertion Segment | Number of change insertion segment during the epidural localization procedure. | 30 minutes |
| Number of the Occurrence of False Positive | the insertion of the epidural catheter is unsuccessful or the perception of cold exists in the blocked dermatomes after the injection of anesthetic by cold sensation test | 30 minutes |
| 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 |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| ASA Physical Status | The ASA physical status classification system (October 15, 2014) is a system for assessing the fitness of patients before surgery. ASA I: A normal healthy patient ASA II: A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: A patient with severe systemic disease that is a constant threat to life ASA V: A moribund patient who is not expected to survive without the operation ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | The Time to Identify the Epidural Space | Defined as the time of the successful localization from the first syringe attached to the Tuohy needle to the occurrence of LOR signal. | Posted | Mean | Standard Deviation | secs | 30 minutes |
|
|
|
| Secondary | Duration of the Epidural Space Localization Procedure | Defined as the time from the puncture of skin to the successful insertion of the epidural catheter. | Posted | Mean | Standard Deviation | secs | 30 minutes |
|
|
|
| Secondary | Number of Attempts | Defined as the insertion of the epidural catheter is unsuccessful or the perception of cold exists in the blocked dermatomes after the injection of anesthetic by cold sensation test. | Posted | Median | Full Range | attempts | 30 minutes |
|
|
|
| Secondary | The Distance From the Skin to the Epidural Space | Defined as the insertion distance of the needle after locating the epidural space. | Posted | Mean | Standard Deviation | mm | 30 minutes |
|
|
|
| Secondary | Number of Change Insertion Segment | Number of change insertion segment during the epidural localization procedure. | Posted | Median | Full Range | segments | 30 minutes |
|
|
|
| Secondary | Number of the Occurrence of False Positive | the insertion of the epidural catheter is unsuccessful or the perception of cold exists in the blocked dermatomes after the injection of anesthetic by cold sensation test | Posted | Median | Full Range | occurrences | 30 minutes |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Detection by EpiFaith Syringe With Saline | Fill the EpiFaith Syringe with saline for LOR detection | 0 | 30 | 0 | 30 | 0 | 30 |
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| Status 3 |
|