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Intensive Care Unit2PACNCT06032169

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

An observational study of Intensive Care Unit and Arterial Catheter, run by Nantes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intensive Care Unit, Arterial Catheter
What is being tested?
Patients of a surgical intensive care unit having an arterial catheter
How many people
51 participants
Where
1 siteFrance
Study dates
4 Oct 2023to 18 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 11Show fewer
  • Asymmetry of mean AP between the two upper arms (> 5 mmHg) or inability to assess it.
  • Pregnancy.
  • Age <18 years old.
  • Adult known to be under guardianship or curatorship before inclusion.
  • Absence of coverage by the French national health insurance (Sécurité sociale).

Trial locations and contacts

1 site in 1 country.

France1 site
  • Nantes University Hospital

    Nantes, Loire-Atlantique, 44093

Other trials in France

About this study

Official title: NON-INVASIVE MEASUREMENT OF ARTERIAL PRESSURE AT THE ANKLE: IMPACT OF POSITION, SEMI-RECUMBENT OR HORIZONTAL. A SINGLE-CENTER PROSPECTIVE STUDY.

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.

Read the detailed description

A question that arises relatively frequently is "when the upper arm is inaccessible, where should the investigators place the automatic cuff to measure AP?". Indeed, surgical intervention involving the upper limb, a wound, a fracture, or vascular access (temporary catheter or arteriovenous fistula) often makes the arm unsuitable for monitoring AP with an automatic cuff. The arterial catheter is not devoid of risks (including the loss of precious time for its insertion) and is rarely an appropriate alternative, at least in the first instance. Thus, the inaccessibility of the upper arm legitimates the frequent placement of the automatic cuff at the ankle. However, the automatic cuff has only been validated for placement at the upper arm, not at the ankle. Surprisingly, the reliability of ankle AP measurements obtained by this positioning of the cuff at the ankle has been little studied: only two studies, using arterial catheter as the reference method, are available, one of which was in the specific population of patients with obesity. These studies reported that the measurement error at the ankle was excessive, but confirmation is necessary.

Patients, especially in acute care settings, are rarely in a strictly horizontal supine position. For various reasons, the critically ill patient is rather in a semi-recumbent position, meaning that the angle between the trunk and the horizontal axis is between 30 and 60°. Thus, the cuff placed at the ankle is no longer at the level of the heart and more precisely of the phlebostatic axis. This could modify the hydrostatic pressure and lead to overestimation of AP compared to a measurement of AP at heart level (on the arm or invasively, for example). Indeed, the impact on AP measurement of the height of the upper arm relative to the heart has already been demonstrated: the vertical displacement of the upper arm changes the measured AP value. Does the angle of elevation of the trunk significantly modify the AP measured at the ankle? If so, and since the measurement at the ankle in the horizontal supine position (0°) tends to underestimate AP, do the different sources of measurement error "cancel out" in the semi-recumbent position? In what position of the trunk is it preferable to measure AP at the ankle? The answers to these questions are uncertain. Indeed, the only study that investigators are aware of (a pilot study) and that specifically addressed this issue did not provide clear answers. This is important since AP is a crucial parameter of monitoring and therefore of therapeutic decision-making. It is remarkable that in acute care settings, little to no attention is paid to trunk elevation when measuring BP at the ankle, and of course, there is no automation of patient positioning (e.g., in a horizontal position) prior to each automatic measurement at the ankle.

Therefore, it appears important to evaluate the accuracy and precision of non-invasive ankle measurements of AP and the impact of patient position on it. This will be the main objective of the study. If these ankle measurements prove to be neither accurate nor precise, having an alternative would be desirable. It is noteworthy that when the arm is inaccessible, the finger often is. AP measurement at the finger is now possible with a simple smartphone. This finger measurement requires calibration with one or two automatic cuff measurements, which should be possible in most cases (the arm is frequently inaccessible for prolonged AP monitoring, but still allows for one or two isolated measurements). So, which is the better alternative site for AP measurement, the finger or ankle? AP measurement using a smartphone has never been evaluated from this perspective. This will be a secondary objective of the study.

Being tested
Patients of a surgical intensive care unit having an arterial catheter
Keywords
Ankle, Calf, Blood pressure determination, Catheterization, Peripheral / methods, Cuff, Oscillometry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients of a surgical intensive care unit having an arterial catheterOther

    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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 15 minutes

Secondary outcomes (5)
  1. 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).

    The AAMI/ESH/ISO standard will indicate if the reliability is acceptable: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.

    Measured: 15 minutes

  2. 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).

    The AAMI/ESH/ISO standard will indicate if the reliability is acceptable: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.

    Measured: 15 minutes

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

    The AAMI/ESH/ISO standard will indicate if the reliability is acceptable: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.

    Measured: 15 minutes

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

    Via a dedicated error grid, the risk associated with measurement errors was classified into one of the 5 risk levels ranging from "no risk" to "dangerous risk". Distribution across the different risk levels was compared by Fisher exact tests.

    Measured: 15 minutes

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

    The ability of averaged noninvasive measurements to detect hypotension (invasive mean Arterial Pressure <65 mmHg, systolic Arterial Pressure <90 mmHg), hypertension (invasive mean Arterial Pressure >100 mmHg, systolic Arterial Pressure >140 mmHg), and a significant therapy-induced change in invasive mean Arterial Pressure (>10%) was determined through area under the receiver operating characteristic curve (AUCROC) analysis.

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2023
  2. Study start4 Oct 2023
  3. Primary completion18 Dec 2023
  4. Study completion18 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06032169
Sponsor's protocol ID
RC23_0233
Acronym
2PAC
Status last verified
Jan 2024
First submitted
6 Jun 2023
Last updated
9 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39774614

Questions about this trial

What is this clinical trial studying?

An observational study of Intensive Care Unit and Arterial Catheter, run by Nantes University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate whether the non-invasive measurement error of ankle mean Arterial Pressure is acceptable in either patient position (semi-recumbent or horizontal). (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06032169, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.

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