Trial Outcomes & Findings for Tetragraph® Monitor: Tolerance of Preoperative Placement (NCT NCT05964166)
NCT ID: NCT05964166
Last Updated: 2024-11-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
30 mins. prior to surgery
Results posted on
2024-11-18
Participant Flow
Participant milestones
| Measure |
Pulled Off Sensor
Patients that pulled off the TetraGraph sensor before arrival to the OR.
|
Sensor Intact
Patients that arrived to the OR with the sensor intact and functioning.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
26
|
|
Overall Study
COMPLETED
|
14
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tetragraph® Monitor: Tolerance of Preoperative Placement
Baseline characteristics by cohort
| Measure |
Pulled Off Sensor
n=14 Participants
Patients that pulled off the TetraGraph sensor before arrival to the OR.
|
Sensor Intact
n=26 Participants
Patients that arrived to the OR with the sensor intact and functioning.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
0.98 years
n=99 Participants
|
5.24 years
n=107 Participants
|
3.70 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
26 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Weight (kg)
|
9.88 kilograms
n=99 Participants
|
20 kilograms
n=107 Participants
|
15.55 kilograms
n=206 Participants
|
|
Height (cm)
|
73.5 centimeters
n=99 Participants
|
110.2 centimeters
n=107 Participants
|
103 centimeters
n=206 Participants
|
|
BMI
|
17.81 kg/m^2
n=99 Participants
|
15.8 kg/m^2
n=107 Participants
|
16.4 kg/m^2
n=206 Participants
|
|
ASA physical status
ASA I
|
3 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
ASA physical status
ASA II
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
ASA physical status
ASA III
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 mins. prior to surgeryPatient'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.
Outcome measures
| Measure |
Pulled Off Sensor
n=14 Participants
Patients that pulled off the TetraGraph sensor before arrival to the OR.
|
Sensor Intact
n=26 Participants
Patients that arrived to the OR with the sensor intact and functioning.
|
|---|---|---|
|
Tolerance to Preop Placement as Assessed by Likert Scale
Family member assessment
|
0 units on a scale (0-10)
Interval 0.0 to 0.0
|
10 units on a scale (0-10)
Interval 10.0 to 10.0
|
|
Tolerance to Preop Placement as Assessed by Likert Scale
Research team member assessment
|
0 units on a scale (0-10)
Interval 0.0 to 0.0
|
10 units on a scale (0-10)
Interval 9.0 to 10.0
|
SECONDARY outcome
Timeframe: 30 minutes prior to surgeryThe 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.
Outcome measures
| Measure |
Pulled Off Sensor
n=14 Participants
Patients that pulled off the TetraGraph sensor before arrival to the OR.
|
Sensor Intact
n=26 Participants
Patients that arrived to the OR with the sensor intact and functioning.
|
|---|---|---|
|
Application Ease
|
4 units on a scale (0-10)
Interval 0.0 to 10.0
|
10 units on a scale (0-10)
Interval 7.0 to 10.0
|
Adverse Events
Pulled Off Sensor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sensor Intact
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place