Accuracy of Non-Invasive Blood Pressure Measurements at the Arm, Calf , and Finger (PANIC)
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ClinicalTrials.gov Identifier: NCT04269382 |
Recruitment Status :
Completed
First Posted : February 13, 2020
Last Update Posted : July 1, 2021
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Condition or disease | Intervention/treatment | Phase |
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Hypotension and Shock Hypertension Intensive Care Unit | Device: Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurements | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 133 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Prospective, Multi-center Evaluation of the Accuracy of Non-invasive Measurement of Blood Pressure Using an Arm, Calf and Finger Cuff. |
Actual Study Start Date : | February 22, 2020 |
Actual Primary Completion Date : | June 2, 2021 |
Actual Study Completion Date : | June 2, 2021 |
Arm | Intervention/treatment |
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Combined non-invasive and invasive BP measurements
Patients will all undergo measurement of BP through 3 different techniques over a 30-min period: continuous noninvasive BP measurement (with the finger cuff and Clearsight™ device), repeated intermittent oscillometric NIBP measurements with a cuff placed around a calf or an arm, and continuous invasive BP measurement (through an indwelling arterial catheter).
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Device: Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurements
Continuous (finger cuff) noninvasive and invasive BP measurements, over a 30-min period. Pairs of noninvasive/invasive BP recorded each minute). In the same time, 3 pairs of oscillometric NIBP (cuff placed around a calf), and invasive BP measurements, at 30-sec intervals. The cuff is then placed around an arm and triplets of BP (arm cuff, finger cuff, intra-arterial catheter) will be taken over a 20-min period, at 3-min intervals and every time the invasive and/or the continuous finger cuff measurements cross the threshold of 65 mmHg for the mean BP. If clinically indicated, a cardiovascular intervention that can be either vascular volume expansion or initiation of vasoactive drug therapy, can be administered during this period. Finally, the cuff placed around the arm will be once again placed around the calf to take 3 pairs of oscillometric NIBP measurement with cuff placed around a calf, and simultaneous invasive BP measurement, at 30-second intervals. |
- Discriminative power of the combined BP measurements with finger cuff and arm cuff to detect intra-arterial mean BP below 65 mmHg [ Time Frame: 30 minutes ]Area under the receiver operating characteristics curve of the combined BP measurements with finger cuff and arm cuff to detect intra-arterial mean BP below 65 mmHg
- Discriminative power of the combined BP measurements with finger cuff and arm cuff to detect intra-arterial systolic hypertension [ Time Frame: 30 minutes ]Area under the receiver operating characteristics curve of the combined BP measurements with finger cuff and arm cuff to detect systolic intra-arterial above 140 mmHg
- Discriminative power of the combined BP measurements with finger cuff and arm cuff to detect intra-arterial diastolic hypertension [ Time Frame: 30 minutes ]Area under the receiver operating characteristics curve of the combined BP measurements with finger cuff and arm cuff to detect diastolic intra-arterial above 90 mmHg
- Accuracy of continuous finger cuff measurements tested against the intra-arterial reference [ Time Frame: 30 minutes ]Accuracy of continuous finger cuff BP measurements tested against the intra-arterial reference, according to the ISO standard
- Accuracy of intermittent, oscillometric arm cuff BP measurements tested against the intra-arterial reference [ Time Frame: 30 minutes ]Accuracy of intermittent, oscillometric arm cuff BP measurements tested against the intra-arterial reference, according to the ISO standard
- Accuracy of intermittent, oscillometric calf cuff measurements tested against the intra-arterial reference [ Time Frame: 30 minutes ]Accuracy of intermittent, oscillometric calf cuff BP measurements tested against the intra-arterial reference, according to the ISO standard
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient hospitalised in one of the three recruiting intensive care units
- Patient already carrying an indwelling arterial catheter
- Stable BP over a 5-min period: no variation of mean BP above 10% and no change in vasopressor therapy
Exclusion Criteria:
- Brachial circumference > 42 cm.
- Any local fracture, wound, ischemic injury, infection, amputation, thrombophlebitis, that could prevent inflating a cuff around the arm or a finger
- Need of emergency therapy not compatible with the BP measurements schedule
- Asymmetry of mean BP between right and left arm (> 5 mmHg)
- Pregnancy
- Age < 18 years
- Patient under curatorship or guardianship
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269382
France | |
CHU de NANTES | |
Nantes, France, 44093 | |
CHR Orléans | |
Orléans, France | |
CHRU de Tours | |
Tours, France, 37044 |
Principal Investigator: | Gregoire MULLER, Dr | CHR Orléans |
Responsible Party: | Centre Hospitalier Régional d'Orléans |
ClinicalTrials.gov Identifier: | NCT04269382 |
Other Study ID Numbers: |
CHRO 2019-09 |
First Posted: | February 13, 2020 Key Record Dates |
Last Update Posted: | July 1, 2021 |
Last Verified: | June 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Blood Pressure Determination |
Hypotension Vascular Diseases Cardiovascular Diseases |