Anesthesia, Surgery
Conditions
Brief summary
This is a prospective study that will compare the blood pressure readings from an arterial cannula with those obtained non-invasively by the NICCI device. The study will enroll 50 patients into each of three weight ranges: 10-20 kg, 20-40 kg, and 40-80 kg. The NICCI, Pulsion/GETINGE uses novel technology to provide a continuous estimation of BP displayed as a waveform similar to that seen with an invasive arterial cannula, but is totally non-invasive by using the fingers. The patient rests their hand on the device, which is about the size of a computer mouse, and then a blood pressure cuff goes around their upper arm.
Interventions
DEVICENICCI
Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
Sponsors
Joseph D. Tobias
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients requiring anesthetic care and in whom an indwelling arterial cannula will be placed for the surgical procedure.
Exclusion criteria
* Patients with history of a peripheral neurologic or neuropathic disorder * Patients in whom the upper extremity cannot be used for blood pressure monitoring * Patients in whom an invasive arterial cannula cannot be placed * Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm) * Edematous patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Blood Pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of BP Values From the NICCI Device That Were ≤ 5 mm Hg the Values Obtained From the AC | 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. 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. |
| Percentage of BP Values From the NICCI Device That Were ≤ 10 mm Hg the Values Obtained From the AC | 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. 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. |
| Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC | 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. 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 44 |
| Total | 68 |
Baseline characteristics
| Characteristic | 10-40 kg | 40-80 kg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 24 Participants | 44 Participants | 68 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 | 11 years STANDARD_DEVIATION 4 | 15 years STANDARD_DEVIATION 2 | 14 years STANDARD_DEVIATION 3 |
| ASA physical class 1 | 1 Participants | 8 Participants | 9 Participants |
| ASA physical class 2 | 10 Participants | 22 Participants | 32 Participants |
| ASA physical class 3 | 10 Participants | 13 Participants | 23 Participants |
| ASA physical class 4 | 3 Participants | 1 Participants | 4 Participants |
| BMI | 17 kg/m^2 STANDARD_DEVIATION 2 | 22 kg/m^2 STANDARD_DEVIATION 4 | 20 kg/m^2 STANDARD_DEVIATION 4 |
| Height | 134 centimeters STANDARD_DEVIATION 19 | 162 centimeters STANDARD_DEVIATION 9 | 153 centimeters STANDARD_DEVIATION 19 |
| Patient position Lateral | 0 Participants | 1 Participants | 1 Participants |
| Patient position Prone | 18 Participants | 40 Participants | 58 Participants |
| Patient position Supine | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 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 | 23 Participants | 35 Participants | 58 Participants |
| Region of Enrollment United States | 24 participants | 44 participants | 68 participants |
| Sex: Female, Male Female | 12 Participants | 23 Participants | 35 Participants |
| Sex: Female, Male Male | 12 Participants | 21 Participants | 33 Participants |
| Weight | 30 kilograms STANDARD_DEVIATION 8 | 56 kilograms STANDARD_DEVIATION 10 | 48 kilograms STANDARD_DEVIATION 15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 44 |
| other Total, other adverse events | 0 / 24 | 0 / 44 |
| serious Total, serious adverse events | 0 / 24 | 0 / 44 |
Outcome results
Primary
Difference in Blood Pressure
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.
Time frame: 2-8 hours (average length of major surgery)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10-40 kg | Difference in Blood Pressure | SBP | 11 mm Hg | Standard Deviation 9 |
| 10-40 kg | Difference in Blood Pressure | DBP | 10 mm Hg | Standard Deviation 7 |
| 10-40 kg | Difference in Blood Pressure | MAP | 10 mm Hg | Standard Deviation 7 |
| 40-80 kg | Difference in Blood Pressure | SBP | 10 mm Hg | Standard Deviation 8 |
| 40-80 kg | Difference in Blood Pressure | DBP | 9 mm Hg | Standard Deviation 7 |
| 40-80 kg | Difference in Blood Pressure | MAP | 9 mm Hg | Standard Deviation 7 |
Secondary
Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10-40 kg | 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 |
| 10-40 kg | 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 |
| 10-40 kg | 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 |
| 40-80 kg | Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC | SBP | 40 percentage of NICCI readings |
| 40-80 kg | Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC | DBP | 33 percentage of NICCI readings |
| 40-80 kg | 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 |
Secondary
Percentage of BP Values From the NICCI Device That Were ≤ 10 mm Hg the Values Obtained From the AC
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10-40 kg | 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 |
| 10-40 kg | 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 |
| 10-40 kg | 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 |
| 40-80 kg | Percentage of BP Values From the NICCI Device That Were ≤ 10 mm Hg the Values Obtained From the AC | SBP | 60 percentage of NICCI readings |
| 40-80 kg | Percentage of BP Values From the NICCI Device That Were ≤ 10 mm Hg the Values Obtained From the AC | DBP | 67 percentage of NICCI readings |
| 40-80 kg | 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 |
Secondary
Percentage of BP Values From the NICCI Device That Were ≤ 5 mm Hg the Values Obtained From the AC
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10-40 kg | 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 |
| 10-40 kg | 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 |
| 10-40 kg | 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 |
| 40-80 kg | Percentage of BP Values From the NICCI Device That Were ≤ 5 mm Hg the Values Obtained From the AC | SBP | 35 percentage of NICCI readings |
| 40-80 kg | Percentage of BP Values From the NICCI Device That Were ≤ 5 mm Hg the Values Obtained From the AC | DBP | 39 percentage of NICCI readings |
| 40-80 kg | 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 |