Accuracy of Non-Invasive Blood Pressure Measurements at the Arm, Calf , and Finger

NCT04269382 | Completed

• 1 other identifier: CHRO 2019-09
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 3

Brief Summary

The present study was designed to assess, in a population of patients admitted to the intensive care unit and already carrying an indwelling arterial catheter, the ability of combined continuous (ClearSight™) and intermittent (automatic cuff) non-invasive monitoring to detect low mean BP (\<65mmHg). The intra-arterial measurement will be the reference measurement. As secondary objectives, the investigators will assess the ability of combined continuous (ClearSight™) and intermittent (automatic cuff) non-invasive monitoring to detect stage 2 hypertension, and to detect changes in BP during a cardiovascular intervention (as clinically indicated but not imposed by the study protocol). Additionally, the accuracy of both devices against the current international standard (ISO standard) will be assessed.

Conditions

Hypotension and Shock; Hypertension; Intensive Care Unit

Keywords

Blood Pressure Determination

Outcome Measures

Primary Outcomes (1)

• Discriminative power of the combined BP measurements with finger cuff and arm cuff to detect intra-arterial mean BP below 65 mmHg

  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

  30 minutes

Secondary Outcomes (5)

• Discriminative power of the combined BP measurements with finger cuff and arm cuff to detect intra-arterial systolic hypertension

  30 minutes

• Discriminative power of the combined BP measurements with finger cuff and arm cuff to detect intra-arterial diastolic hypertension

  30 minutes

• Accuracy of continuous finger cuff measurements tested against the intra-arterial reference

  30 minutes

• Accuracy of intermittent, oscillometric arm cuff BP measurements tested against the intra-arterial reference

  30 minutes

• Accuracy of intermittent, oscillometric calf cuff measurements tested against the intra-arterial reference

  30 minutes

Study Arms (1)

Combined non-invasive and invasive BP measurements

OTHER

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).

Device: Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurements

Interventions

Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurements DEVICE

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.

Combined non-invasive and invasive BP measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (3)

CHU de NANTES

Nantes, 44093, France

Location

CHR Orléans

Orléans, France

Location

CHRU de Tours

Tours, 37044, France

Location

Related Publications (2)

• Lakhal K, Dauvergne JE, Messet-Charriere H, Nay MA, Kamel T, Muller G, Robert-Edan V, Rozec B, Ehrmann S, Jacquier S, Boulain T. Risk factors for poor performance in finger cuff non-invasive monitoring of arterial pressure: A prospective multicenter study. Anaesth Crit Care Pain Med. 2024 Apr;43(2):101333. doi: 10.1016/j.accpm.2023.101333. Epub 2023 Dec 2.

  PMID: 38048986 DERIVED

• Lakhal K, Dauvergne JE, Kamel T, Messet-Charriere H, Jacquier S, Robert-Edan V, Nay MA, Rozec B, Ehrmann S, Muller G, Boulain T. Noninvasive Monitoring of Arterial Pressure: Finger or Lower Leg As Alternatives to the Upper Arm: A Prospective Study in Three ICUs. Crit Care Med. 2023 Oct 1;51(10):1350-1362. doi: 10.1097/CCM.0000000000005945. Epub 2023 May 26.

  PMID: 37232853 DERIVED

MeSH Terms

Conditions

Hypotension; Shock; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregoire MULLER, Dr

  CHR Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: February 22, 2020
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Locations

FR (3)