Surgery
Conditions
Brief summary
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.
Interventions
DEVICETetraGraph NMT Monitor
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.
Sponsors
Joseph D. Tobias
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Patients requiring anesthetic care and use of neuromuscular blockade 2. Age ≤ 12 years 3. ASA 1-4
Exclusion criteria
1. History of a peripheral neurologic or neuropathic disorder 2. Upper extremity cannot be used for TOF monitoring 3. Undergoing a surgical procedure in which neuromuscular blockade is not required 4. Patient is edematous 5. Patients with significant behavioral or neurocognitive issues which affect behavior and impact the ability to place the sensor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance to Preop Placement as Assessed by Likert Scale | 30 mins. prior to surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Application Ease | 30 minutes prior to surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pulled Off Sensor Patients that pulled off the TetraGraph sensor before arrival to the OR. | 14 |
| Sensor Intact Patients that arrived to the OR with the sensor intact and functioning. | 26 |
| Total | 40 |
Baseline characteristics
| Characteristic | Pulled Off Sensor | Sensor Intact | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 26 Participants | 40 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 0.98 years | 5.24 years | 3.70 years |
| ASA physical status ASA I | 3 Participants | 11 Participants | 14 Participants |
| ASA physical status ASA II | 8 Participants | 10 Participants | 18 Participants |
| ASA physical status ASA III | 3 Participants | 5 Participants | 8 Participants |
| BMI | 17.81 kg/m^2 | 15.8 kg/m^2 | 16.4 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 25 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height (cm) | 73.5 centimeters | 110.2 centimeters | 103 centimeters |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 19 Participants | 30 Participants |
| Region of Enrollment United States | 14 participants | 26 participants | 40 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 11 Participants | 20 Participants | 31 Participants |
| Weight (kg) | 9.88 kilograms | 20 kilograms | 15.55 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 26 |
| other Total, other adverse events | 0 / 14 | 0 / 26 |
| serious Total, serious adverse events | 0 / 14 | 0 / 26 |
Outcome results
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.
Time frame: 30 mins. prior to surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pulled Off Sensor | Tolerance to Preop Placement as Assessed by Likert Scale | Research team member assessment | 0 units on a scale (0-10) |
| Pulled Off Sensor | Tolerance to Preop Placement as Assessed by Likert Scale | Family member assessment | 0 units on a scale (0-10) |
| Sensor Intact | Tolerance to Preop Placement as Assessed by Likert Scale | Research team member assessment | 10 units on a scale (0-10) |
| Sensor Intact | Tolerance to Preop Placement as Assessed by Likert Scale | Family member assessment | 10 units on a scale (0-10) |
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.
Time frame: 30 minutes prior to surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pulled Off Sensor | Application Ease | 4 units on a scale (0-10) |
| Sensor Intact | Application Ease | 10 units on a scale (0-10) |