Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, non-blinded, single arm study. The primary objective of this study is to evaluate the tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetragraph | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TetraGraph NMT Monitor | Device | TetraGraph is a unique, EMG=based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance to Preop Placement as Assessed by Likert Scale | Patient's tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by using a 10-point Likert scale with 0=very badly/pulled sensor off and 10=very well/left sensor alone. | 30 mins. prior to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Application Ease | The ease of preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by the research staff by using a 10-point Likert scale with 0=very difficult and 10=very easy. | 30 minutes prior to surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pulled Off Sensor | Patients that pulled off the TetraGraph sensor before arrival to the OR. |
| FG001 | Sensor Intact | Patients that arrived to the OR with the sensor intact and functioning. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pulled Off Sensor | Patients that pulled off the TetraGraph sensor before arrival to the OR. |
| BG001 | Sensor Intact | Patients that arrived to the OR with the sensor intact and functioning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Tolerance to Preop Placement as Assessed by Likert Scale | Patient's tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by using a 10-point Likert scale with 0=very badly/pulled sensor off and 10=very well/left sensor alone. | Posted | Median | Inter-Quartile Range | units on a scale (0-10) | 30 mins. prior to surgery |
|
Day of surgery
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pulled Off Sensor | Patients that pulled off the TetraGraph sensor before arrival to the OR. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Tobias | Nationwide Children's Hospital | 6147224200 | Joseph.Tobias@nationwidechildrens.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2023 | Oct 30, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2023 | Oct 30, 2024 | SAP_002.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Median | Inter-Quartile Range | kilograms |
|
| Height (cm) | Median | Inter-Quartile Range | centimeters |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| ASA physical status | American Society of Anesthesiologists classification system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. ASA 1 = healthy patient, 2 = mild systemic disease, 3 = severe systemic disease, 4 = severe systemic disease that is a constant threat to life. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Application Ease | The ease of preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by the research staff by using a 10-point Likert scale with 0=very difficult and 10=very easy. | Posted | Median | Inter-Quartile Range | units on a scale (0-10) | 30 minutes prior to surgery |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Sensor Intact | Patients that arrived to the OR with the sensor intact and functioning. | 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided
Not provided