Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04269382 |
Other study ID # |
CHRO 2019-09 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 22, 2020 |
Est. completion date |
June 2, 2021 |
Study information
Verified date |
June 2021 |
Source |
Centre Hospitalier Régional d'Orléans |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
The measurement of arterial blood pressure (BP) is of paramount importance when caring for
critically ill patients, as BP, especially mean BP, is the driving force of blood flow
through all the organs. The reference method is the invasive method that measures BP
continuously and directly in an artery (most often the radial artery), through an indwelling
arterial catheter. A popular, less invasive method, most often used in emergency situations
or during the first hours of care in the intensive care unit (ICU), is the non-invasive
oscillometric method (NIBP) using an arm cuff (some have shown that the cuff could also be
placed around the calf, just above the ankle), that provides only intermittent measurements.
In between the above 2 techniques, the place of continuous non-invasive BP monitoring devices
using a different technology (plethysmography and volume clamp technique) and a cuff placed
around a finger is uncertain. It would be interesting to evaluate whether the 2 non-invasive
techniques (using arm or finger cuff) can be advantageously combined either to replace
invasive monitoring or to reinforce non-invasive monitoring (in patients in whom an arterial
catheter is not envisaged). In the critically ill patient, reliable detection of low BP is
often the most important task assigned to BP monitoring devices, at least in the initial
phase of management. It is conceivable that if the finger cuff (ClearSight™ device) was not
infallible in measuring BP, low BP could still be detected sufficiently reliably by the
finger cuff (even with weak accuracy), giving an early warning. The arm measurement could
then confirm hypotension in a robust, on-demand manner, since the ability of the arm cuff to
detect hypotension has already been demonstrated. The ability to detect hypotension using a
combined non-invasive approach (finger and arm cuff) has never been explored with the
ClearSight™ device. This combined approach could similarly detect high blood pressure or a
rapid change in BP as a result of cardiovascular intervention. In addition, the automatic
cuff cannot always be placed around the arm (presence of wounds, burns, fractures or surgery
of the upper limb, venous catheter, etc.) for intermittent NIBP measurements, and is then
placed around the calf. However, this commonly observed practice exposes the NIBP measurement
to less accuracy. The finger cuff could be an alternative to the calf cuff. However, the
accuracy of finger measurement has never been compared to the accuracy of oscillometric
measurement at the calf.