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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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

2-8 hours (average length of major surgery)

Results posted on

2023-04-18

Participant Flow

Participant milestones

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

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=5 Participants
44 Participants
n=7 Participants
68 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
11 years
STANDARD_DEVIATION 4 • n=5 Participants
15 years
STANDARD_DEVIATION 2 • n=7 Participants
14 years
STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
23 Participants
n=7 Participants
35 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
21 Participants
n=7 Participants
33 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
6 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
White
23 Participants
n=5 Participants
35 Participants
n=7 Participants
58 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
24 participants
n=5 Participants
44 participants
n=7 Participants
68 participants
n=5 Participants
Weight
30 kilograms
STANDARD_DEVIATION 8 • n=5 Participants
56 kilograms
STANDARD_DEVIATION 10 • n=7 Participants
48 kilograms
STANDARD_DEVIATION 15 • n=5 Participants
Height
134 centimeters
STANDARD_DEVIATION 19 • n=5 Participants
162 centimeters
STANDARD_DEVIATION 9 • n=7 Participants
153 centimeters
STANDARD_DEVIATION 19 • n=5 Participants
BMI
17 kg/m^2
STANDARD_DEVIATION 2 • n=5 Participants
22 kg/m^2
STANDARD_DEVIATION 4 • n=7 Participants
20 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
Patient position
Prone
18 Participants
n=5 Participants
40 Participants
n=7 Participants
58 Participants
n=5 Participants
Patient position
Supine
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Patient position
Lateral
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
ASA physical class
1
1 Participants
n=5 Participants
8 Participants
n=7 Participants
9 Participants
n=5 Participants
ASA physical class
2
10 Participants
n=5 Participants
22 Participants
n=7 Participants
32 Participants
n=5 Participants
ASA physical class
3
10 Participants
n=5 Participants
13 Participants
n=7 Participants
23 Participants
n=5 Participants
ASA physical class
4
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 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

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

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

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

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
SBP
43 percentage of NICCI readings
40 percentage of NICCI readings
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

Adverse Events

10-40 kg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

40-80 kg

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

Dr. Joseph D. Tobias

Nationwide Children's Hospital

Phone: 614-722-4200

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place