Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10-40 kg | Experimental | Patients undergoing major surgery that weigh between 10-20 kg. |
|
| 40-80 kg | Experimental | Patients undergoing major surgery that weigh between 40-80 kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NICCI | Device | Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-8 hours (average length of major surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 40-80 kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mm Hg | 2-8 hours (average length of major surgery) |
|
1 week after surgery
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph D. Tobias | Nationwide Children's Hospital | 614-722-4200 | joseph.tobias@nationwidechildrens.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2020 | Dec 20, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2-8 hours (average length of major surgery) |
| 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. | 2-8 hours (average length of major surgery) |
| 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. | 2-8 hours (average length of major surgery) |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Patient position | Count of Participants | Participants |
|
| ASA physical class | American Society of Anesthesiologists classification system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. ASA 1 = healthy patient, 2 = mild systemic disease, 3 = severe systemic disease, 4 = severe systemic disease that is a constant threat to life. | Count of Participants | Participants |
|
| 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. |
|
|
| 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. | The study team analyzed pairs of SBP, DBP, and MAP values from the NICCI device and the arterial canula. | Posted | Number | percentage of NICCI readings | 2-8 hours (average length of major surgery) | pairs of SBP, DBP, and MAP values | pairs of SBP, DBP, and MAP values |
|
|
|
| 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. | The study team analyzed pairs of SBP, DBP, and MAP values from the NICCI device and the arterial canula. | Posted | Number | percentage of NICCI readings | 2-8 hours (average length of major surgery) | pairs of SBP, DBP, and MAP values | pairs of SBP, DBP, and MAP values |
|
|
|
| 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. | The study team analyzed pairs of SBP, DBP, and MAP values from the NICCI device and the arterial canula. | Posted | Number | percentage of NICCI readings | 2-8 hours (average length of major surgery) | pairs of SBP, DBP, and MAP values | pairs of SBP, DBP, and MAP values |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. | 0 | 44 | 0 | 44 | 0 | 44 |
Not provided
Not provided
Not provided
| MAP |
|
| MAP |
|
| MAP |
|