Hypotension and ShockPANICNCT04269382
Accuracy of Non-Invasive Blood Pressure Measurements at the Arm, Calf , and Finger
A study testing Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurements in people with Hypotension and Shock and Hypertension, run by Centre Hospitalier Régional d'Orléans at 3 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension and Shock, Hypertension, Intensive Care Unit
- What is being tested?
- Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Feb 2020to 2 Jun 2021
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de NANTES
Nantes, 44093
CHR Orléans
Orléans
CHRU de Tours
Tours, 37044
About this study
Official title: Prospective, Multi-center Evaluation of the Accuracy of Non-invasive Measurement of Blood Pressure Using an Arm, Calf and Finger Cuff.
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.
Read the detailed 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.
- Conditions
- Hypotension and Shock, Hypertension, Intensive Care Unit
- Being tested
- Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurements
- Keywords
- Blood Pressure Determination
- Medical subject headings
- Hypotension, Shock, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurementsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (5)
Discriminative power of the combined BP measurements with finger cuff and arm cuff to detect intra-arterial systolic hypertension
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
Measured: 30 minutes
Discriminative power of the combined BP measurements with finger cuff and arm cuff to detect intra-arterial diastolic hypertension
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
Measured: 30 minutes
Accuracy of continuous finger cuff measurements tested against the intra-arterial reference
Accuracy of continuous finger cuff BP measurements tested against the intra-arterial reference, according to the ISO standard
Measured: 30 minutes
Accuracy of intermittent, oscillometric arm cuff BP measurements tested against the intra-arterial reference
Accuracy of intermittent, oscillometric arm cuff BP measurements tested against the intra-arterial reference, according to the ISO standard
Measured: 30 minutes
Accuracy of intermittent, oscillometric calf cuff measurements tested against the intra-arterial reference
Accuracy of intermittent, oscillometric calf cuff BP measurements tested against the intra-arterial reference, according to the ISO standard
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start22 Feb 2020
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypotension and ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregoire MULLER, Dr, Principal investigator, CHR Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269382
- Sponsor's protocol ID
- CHRO 2019-09
- Acronym
- PANIC
- Status last verified
- Jun 2021
- First submitted
- 11 Feb 2020
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38048986Lakhal 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.
PubMed 37232853
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center Evaluation of the Accuracy of Non-invasive Measurement of Blood Pressure Using an Arm, Calf and Finger Cuff.
- ClinicalTrials.gov ID
- NCT04269382
- Acronym / sponsor ID
- PANIC / CHRO 2019-09
- Conditions
- Hypotension and Shock, Hypertension, Intensive Care Unit
- Keywords
- Blood Pressure Determination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 22 Feb 2020 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined non-invasive and invasive BP measurements | Other | Device: Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurementsPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurementsContinuous (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. | Device | Combined non-invasive and invasive BP measurements |
Primary outcome
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
5 secondary outcomes
Discriminative power of the combined BP measurements with finger cuff and arm cuff to detect intra-arterial systolic hypertension
Time frame: 30 minutes
Discriminative power of the combined BP measurements with finger cuff and arm cuff to detect intra-arterial diastolic hypertension
Time frame: 30 minutes
Accuracy of continuous finger cuff 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
Time frame: 30 minutes
Accuracy of intermittent, oscillometric calf cuff measurements tested against the intra-arterial reference
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 38048986Lakhal 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.
- Derived from this study: PubMed 37232853Lakhal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregoire MULLER, Dr principal investigator
CHR Orléans
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurements in people with Hypotension and Shock and Hypertension, run by Centre Hospitalier Régional d'Orléans at 3 sites 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 3 inclusion and 7 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 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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). 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 NCT04269382, which also lists 2 linked publications.
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 1 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.