Ankle Measurements of Arterial Pressure: Semi-recumbent or Horizontal Position.

NCT06032169 | Completed

• 1 other identifier: RC23_0233
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The upper arm is sometimes inaccessible for arterial pressure (AP) measurement. Placing the automatic cuff at the ankle is a common alternative. However, whether AP measurement at the ankle is reliable is uncertain. Furthermore, it is unknown whether it is necessary to place the patient in a horizontal position to improve the reliability of the measurement, or if leaving the patient in default position (often semi-recumbent) is acceptable. The aim of this study is to answer these questions. Additionally, investigators will evaluate whether a smartphone application that allows for the simple measurement of AP (by gently placing a finger on the camera lens) is a valuable alternative to upper arm measurements.

Conditions

Intensive Care Unit; Arterial Catheter

Keywords

Ankle; Calf; Blood pressure determination; Catheterization, Peripheral / methods; Cuff; Oscillometry

Outcome Measures

Primary Outcomes (1)

• To evaluate whether the non-invasive measurement error of ankle mean Arterial Pressure is acceptable in either patient position (semi-recumbent or horizontal).

  The measurement error will be considered acceptable if the current international standard, the AAMI/ESH/ISO standard, is met: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg. The reference AP will be measured using an arterial catheter, taking advantage of the fact that many critically ill patients already have one.

  15 minutes

Secondary Outcomes (5)

• To evaluate whether the non-invasive measurement error of ankle systolic and diastolic Arterial Pressure is acceptable in either patient position (semi-recumbent or horizontal).

  15 minutes

• To evaluate whether the non-invasive measurement error of mean, systolic and diastolic Arterial Pressure at the upper arm is acceptable in either patient position (semi-recumbent or horizontal).

  15 minutes

• To evaluate whether the non-invasive measurement error of mean, systolic and diastolic Arterial Pressure with a smartphone is acceptable.

  15 minutes

• To evaluate the risk associated with measurement errors of systolic and mean Arterial Pressure with each technique at each position.

  15 minutes

• To evaluate the ability of noninvasive measurements to detect hypo-/hypertension.

  15 minutes

Interventions

Patients of a surgical intensive care unit having an arterial catheter OTHER

Patients of a surgical intensive care unit having an arterial catheter undergoing noninvasive measurements of AP in the two studied positions (semi-recumbent or horizontal).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of a surgical intensive care unit having an arterial catheter.

You may qualify if:

• Patients having a catheter in the radial artery.
• and with stable AP over a 5-min period (no change in invasive mean AP \>10% and no change in vasoactive drugs)

You may not qualify if:

• Cardiac arrhythmia.
• Dysfunction of the arterial catheter and/or waveform suggesting an over- or an under-damping.
• Arm circumference \> 42 cm (measured at mid-arm).
• Contraindication to AP measurement at the arm (fracture, wound, amputated limb, limb ischemia, infection, phlebitis, history of lymph node dissection, venous access used on this limb and contraindicating inflation, other).
• Contraindication to the horizontal supine position or to the semi-recumbent position, even transiently.
• Patient's health condition requiring urgent care that is incompatible with the study protocol.
• Asymmetry of mean AP between the two upper arms (\> 5 mmHg) or inability to assess it.
• Pregnancy.
• Age \<18 years old.
• Absence of coverage by the French national health insurance (Sécurité sociale).

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

Related Publications (1)

• Lakhal K, Dauvergne JE, Audran A, Normand G, Rozec B, Boulain T. Comparison of blood pressure measurements between a smartphone application and the upper arm automated cuff: a prospective study with an invasive reference. Eur J Cardiovasc Nurs. 2025 Apr 11;24(3):478-482. doi: 10.1093/eurjcn/zvaf002.

  PMID: 39774614 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: September 11, 2023
• Study Start: October 4, 2023
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

FR (1)