Trial Outcomes & Findings for Accuracy of the NICCI™ Monitor in Children and Adolescents (NCT NCT04373746)
NCT ID: NCT04373746
Last Updated: 2023-04-18
Results Overview
The absolute difference of the SBP, DBP, and MAP values from the arterial cannula (AC) and NICCI device were calculated. Instead of the directional difference (positive or negative), the absolute difference was used to avoid affecting the data when calculating the mean and standard deviation (SD) of the differences. For instance, if the reading from the NICCI device was 5 mm Hg above or below the reading from the AC, a value of 5 mm Hg was used and not -5 mm Hg or +5 mm Hg.
COMPLETED
NA
82 participants
2-8 hours (average length of major surgery)
2023-04-18
Participant Flow
Participant milestones
| Measure |
10-40 kg
Patients undergoing major surgery that weigh between 10-40 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
40-80 kg
Patients undergoing major surgery that weigh between 40-80 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
51
|
|
Overall Study
COMPLETED
|
24
|
44
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Accuracy of the NICCI™ Monitor in Children and Adolescents
Baseline characteristics by cohort
| Measure |
10-40 kg
n=24 Participants
Patients undergoing major surgery that weigh between 10-40 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
40-80 kg
n=44 Participants
Patients undergoing major surgery that weigh between 40-80 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
68 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
|
11 years
STANDARD_DEVIATION 4 • n=99 Participants
|
15 years
STANDARD_DEVIATION 2 • n=107 Participants
|
14 years
STANDARD_DEVIATION 3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
33 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
|
1 Participants
n=107 Participants
|
1 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
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 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
|
24 participants
n=99 Participants
|
44 participants
n=107 Participants
|
68 participants
n=206 Participants
|
|
Weight
|
30 kilograms
STANDARD_DEVIATION 8 • n=99 Participants
|
56 kilograms
STANDARD_DEVIATION 10 • n=107 Participants
|
48 kilograms
STANDARD_DEVIATION 15 • n=206 Participants
|
|
Height
|
134 centimeters
STANDARD_DEVIATION 19 • n=99 Participants
|
162 centimeters
STANDARD_DEVIATION 9 • n=107 Participants
|
153 centimeters
STANDARD_DEVIATION 19 • n=206 Participants
|
|
BMI
|
17 kg/m^2
STANDARD_DEVIATION 2 • n=99 Participants
|
22 kg/m^2
STANDARD_DEVIATION 4 • n=107 Participants
|
20 kg/m^2
STANDARD_DEVIATION 4 • n=206 Participants
|
|
Patient position
Prone
|
18 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Patient position
Supine
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Patient position
Lateral
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
ASA physical class
1
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
ASA physical class
2
|
10 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
ASA physical class
3
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
ASA physical class
4
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2-8 hours (average length of major surgery)The absolute difference of the SBP, DBP, and MAP values from the arterial cannula (AC) and NICCI device were calculated. Instead of the directional difference (positive or negative), the absolute difference was used to avoid affecting the data when calculating the mean and standard deviation (SD) of the differences. For instance, if the reading from the NICCI device was 5 mm Hg above or below the reading from the AC, a value of 5 mm Hg was used and not -5 mm Hg or +5 mm Hg.
Outcome measures
| Measure |
10-40 kg
n=24 Participants
Patients undergoing major surgery that weigh between 10-40 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
40-80 kg
n=44 Participants
Patients undergoing major surgery that weigh between 40-80 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
|---|---|---|
|
Difference in Blood Pressure
SBP
|
11 mm Hg
Standard Deviation 9
|
10 mm Hg
Standard Deviation 8
|
|
Difference in Blood Pressure
DBP
|
10 mm Hg
Standard Deviation 7
|
9 mm Hg
Standard Deviation 7
|
|
Difference in Blood Pressure
MAP
|
10 mm Hg
Standard Deviation 7
|
9 mm Hg
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 2-8 hours (average length of major surgery)Population: The study team analyzed pairs of SBP, DBP, and MAP values from the NICCI device and the arterial canula.
The absolute difference of the SBP, DBP, and MAP values from the arterial cannula (AC) and NICCI device were calculated. Instead of the directional difference (positive or negative), the absolute difference was used to avoid affecting the data when calculating the mean and standard deviation (SD) of the differences. For instance, if the reading from the NICCI device was 5 mm Hg above or below the reading from the AC, a value of 5 mm Hg was used and not -5 mm Hg or +5 mm Hg. We also calculated the percentage of BP values from the NICCI device that were ≤ 5 mm Hg, ≤ 10 mm Hg, and \> 10 mm Hg from the values obtained from the AC.
Outcome measures
| Measure |
10-40 kg
n=146562 pairs of SBP, DBP, and MAP values
Patients undergoing major surgery that weigh between 10-40 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
40-80 kg
n=383126 pairs of SBP, DBP, and MAP values
Patients undergoing major surgery that weigh between 40-80 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
|---|---|---|
|
Percentage of BP Values From the NICCI Device That Were ≤ 5 mm Hg the Values Obtained From the AC
SBP
|
32 percentage of NICCI readings
|
35 percentage of NICCI readings
|
|
Percentage of BP Values From the NICCI Device That Were ≤ 5 mm Hg the Values Obtained From the AC
DBP
|
35 percentage of NICCI readings
|
39 percentage of NICCI readings
|
|
Percentage of BP Values From the NICCI Device That Were ≤ 5 mm Hg the Values Obtained From the AC
MAP
|
31 percentage of NICCI readings
|
31 percentage of NICCI readings
|
SECONDARY outcome
Timeframe: 2-8 hours (average length of major surgery)Population: The study team analyzed pairs of SBP, DBP, and MAP values from the NICCI device and the arterial canula.
The absolute difference of the SBP, DBP, and MAP values from the arterial cannula (AC) and NICCI device were calculated. Instead of the directional difference (positive or negative), the absolute difference was used to avoid affecting the data when calculating the mean and standard deviation (SD) of the differences. For instance, if the reading from the NICCI device was 5 mm Hg above or below the reading from the AC, a value of 5 mm Hg was used and not -5 mm Hg or +5 mm Hg. We also calculated the percentage of BP values from the NICCI device that were ≤ 5 mm Hg, ≤ 10 mm Hg, and \> 10 mm Hg from the values obtained from the AC.
Outcome measures
| Measure |
10-40 kg
n=146562 pairs of SBP, DBP, and MAP values
Patients undergoing major surgery that weigh between 10-40 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
40-80 kg
n=383126 pairs of SBP, DBP, and MAP values
Patients undergoing major surgery that weigh between 40-80 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
|---|---|---|
|
Percentage of BP Values From the NICCI Device That Were ≤ 10 mm Hg the Values Obtained From the AC
SBP
|
57 percentage of NICCI readings
|
60 percentage of NICCI readings
|
|
Percentage of BP Values From the NICCI Device That Were ≤ 10 mm Hg the Values Obtained From the AC
DBP
|
60 percentage of NICCI readings
|
67 percentage of NICCI readings
|
|
Percentage of BP Values From the NICCI Device That Were ≤ 10 mm Hg the Values Obtained From the AC
MAP
|
56 percentage of NICCI readings
|
56 percentage of NICCI readings
|
SECONDARY outcome
Timeframe: 2-8 hours (average length of major surgery)Population: The study team analyzed pairs of SBP, DBP, and MAP values from the NICCI device and the arterial canula.
The absolute difference of the SBP, DBP, and MAP values from the arterial cannula (AC) and NICCI device were calculated. Instead of the directional difference (positive or negative), the absolute difference was used to avoid affecting the data when calculating the mean and standard deviation (SD) of the differences. For instance, if the reading from the NICCI device was 5 mm Hg above or below the reading from the AC, a value of 5 mm Hg was used and not -5 mm Hg or +5 mm Hg. We also calculated the percentage of BP values from the NICCI device that were ≤ 5 mm Hg, ≤ 10 mm Hg, and \> 10 mm Hg from the values obtained from the AC.
Outcome measures
| Measure |
10-40 kg
n=146562 pairs of SBP, DBP, and MAP values
Patients undergoing major surgery that weigh between 10-40 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
40-80 kg
n=383126 pairs of SBP, DBP, and MAP values
Patients undergoing major surgery that weigh between 40-80 kg.
NICCI: Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
|
|---|---|---|
|
Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC
DBP
|
40 percentage of NICCI readings
|
33 percentage of NICCI readings
|
|
Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC
MAP
|
44 percentage of NICCI readings
|
44 percentage of NICCI readings
|
|
Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC
SBP
|
43 percentage of NICCI readings
|
40 percentage of NICCI readings
|
Adverse Events
10-40 kg
40-80 kg
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