Blood PressurePA-COUCHENCT07687771
Blood Pressure Measured on the Arm With Different Layers of Clothing Versus on the Bare Arm in Patients at Grenoble Alpes University Hospital
An observational study of Blood Pressure, run by University Hospital, Grenoble.
Trial summary
Blood pressure (BP) is an essential physiological parameter for assessing patient condition. In pre-hospital emergency situations it is measured at the arm over the patient's clothing when the patient cannot be undressed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Blood pressure measurement
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jan 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: patient admitted in the Emergency department of Grenoble University Hospital
Who may be able to join
- Patient over 18 years admitted to the emergency department of Grenoble University Hospital
- No objection by the subject to the study
- Affiliated to the French social security system (or equivalent)
Who cannot join
- Physical inability to collect BP at the admission in the emergency department (pain, arm wound)
- Technical inability to collect BP at the admission in the emergency department (incompatible size of the cuffs)
- Medical or surgical contraindication to repeated blood pressure measurement on both arms
- Patient who received antihypertensive treatment within the hour prior to measurements
- Unable to communicate or non-french speaking patients or those with impaired comprehension or consciousness
- Protected persons referred to in articles L1121-6 and L1121-8 of French public health code (deprived of liberty, tutorship or curatorship)
- The patient already enrolled in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Blood pressure (BP) is an essential physiological parameter for assessing patient condition. In pre-hospital emergency situations it is measured at the arm over the patient's clothing when the patient cannot be undressed.
However there is no study proving the reliability of this measurement compared to measurement according to recommendations (blood pressure cuff).
This lack of proof could lead to misinterpretation when measurement conditions are not optimal.
Read the detailed description
The study will be conducted in the Emergency Department (ED) of Grenoble University Hospital.
The main objective of this observational study is to assess variations in blood pressure measurements based on the patient's clothing layers compared to the reference blood pressure measurement on the bare arm.
Once admitted to the Emergency Department (ED) the patient may be enrolled in the study according to the inclusion and non-inclusion criteria and after obtaining his consent.
Several series of blood pressure measurements are taken:
- A series taken on the bare arm as control
- A series of measurements using sleeves of different thicknesses in random order. 3 types of sleeves will be used for which 3 measurements will be realised. A total of 12 measurements will be taken for each patient.
These measurements will be taken during the waiting period between the patient's initial assessment by the Triage Nurse upon arrival and their transfer to the emergency department assignment unit thereby ensuring that the patient's normal care is not delayed.
All measurements will be performed by the investigator using the same blood pressure monitorind device.
For each measurement systolic and diastolic blood pressure are collected and used to estimate a MAP.The average of the 3 values obtained are compared to determine whether there is a significat difference between the MAP measured over a layer of clothing (i.e a sleeve) and that measured on a bare arm .
Regarding the sleeves three sleeves thicknesses will be tested :
- a thin sleeve (base layer + technical fleece vest)
- a thick sleeve (thin layer + down jacket + windproof interface Gore - Tex type)
- a "canyon" type sleeve ( neoprene wetsuit)
These sleeves will be provided by the investigators and will remain the same throughout the study.
- Conditions
- Blood Pressure
- Being tested
- Blood pressure measurement
- Keywords
- Blood Pressure measurement, Bar Arm, Sleeve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurementOther
Blood pressure measurements in addition to the standard care at patients admitted in the Emergency department as follow:
- 3 Blood pressure measurements on bare arm serving as control in accordance with the guidelines.
- 3 Blood pressure measurements over sleeves of varying thicknesses (thin, thick, and canyon)
| Study group | Role | What they receive |
|---|---|---|
| Patient admitted in the Emergency Department | Adult patient admitted in the Emergengy Department of Grenoble University Hospital will have several series of blood pressure measurement (12 in total) .
Each patient will serve as case and control (i,e compared to himself). Receives: Other: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between MAP measured over clothing and the average MAP measured on the bare arm
Differences between the mean arterial pressure (MAP) measured over clothing and the average MAP measured on the bare arm
Measured: 20 minutes
Secondary outcomes (4)
Differences between MAP measured between the various layers of clothing.
Differences between the mean of MAP measured between the various layers of clothing.
Measured: 20 minutes
Error rate between groups with sleeves compared with the control group
Measurement error rate between groups with sleeves compared with the control group
Measured: 20 minutes
Difference in the mean of systolic blood pressure values measured between the groups with sleeves and the control group.
Difference in the mean of systolic blood pressure values measured between the groups with sleeves and the control group.
Measured: 20 minutes
Difference of MAP measured between sleeves and control group in hypotensive patients
Difference in the mean of MAP measured between sleeves and control group in hypotensive patients
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 161 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JEREMY CHARLES, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687771
- Sponsor's protocol ID
- 38RC26.0150
- Other IDs
- IDRCB :2026-A00880-51
- Acronym
- PA-COUCHE
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor. In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Measured on the Arm With Different Layers of Clothing Versus on the Bare Arm in Patients at Grenoble Alpes University Hospital
- ClinicalTrials.gov ID
- NCT07687771
- Acronym / sponsor ID
- PA-COUCHE / 38RC26.0150
- Conditions
- Blood Pressure
- Keywords
- Blood Pressure measurement, Bar Arm, Sleeve
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 161 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 7 Jul 2026 (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.
Blood pressure (BP) is an essential physiological parameter for assessing patient condition. In pre-hospital emergency situations it is measured at the arm over the patient's clothing when the patient cannot be undressed.
However there is no study proving the reliability of this measurement compared to measurement according to recommendations (blood pressure cuff).
This lack of proof could lead to misinterpretation when measurement conditions are not optimal.
Detailed description
The study will be conducted in the Emergency Department (ED) of Grenoble University Hospital.
The main objective of this observational study is to assess variations in blood pressure measurements based on the patient's clothing layers compared to the reference blood pressure measurement on the bare arm.
Once admitted to the Emergency Department (ED) the patient may be enrolled in the study according to the inclusion and non-inclusion criteria and after obtaining his consent.
Several series of blood pressure measurements are taken:
- A series taken on the bare arm as control
- A series of measurements using sleeves of different thicknesses in random order. 3 types of sleeves will be used for which 3 measurements will be realised. A total of 12 measurements will be taken for each patient.
These measurements will be taken during the waiting period between the patient's initial assessment by the Triage Nurse upon arrival and their transfer to the emergency department assignment unit thereby ensuring that the patient's normal care is not delayed.
All measurements will be performed by the investigator using the same blood pressure monitorind device.
For each measurement systolic and diastolic blood pressure are collected and used to estimate a MAP.The average of the 3 values obtained are compared to determine whether there is a significat difference between the MAP measured over a layer of clothing (i.e a sleeve) and that measured on a bare arm .
Regarding the sleeves three sleeves thicknesses will be tested :
- a thin sleeve (base layer + technical fleece vest)
- a thick sleeve (thin layer + down jacket + windproof interface Gore - Tex type)
- a "canyon" type sleeve ( neoprene wetsuit)
These sleeves will be provided by the investigators and will remain the same throughout the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient admitted in the Emergency Department | – | Other: Blood pressure measurementAdult patient admitted in the Emergengy Department of Grenoble University Hospital will have several series of blood pressure measurement (12 in total) . Each patient will serve as case and control (i,e compared to himself). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient admitted in the Emergency department of Grenoble University Hospital
Key inclusion criteria (3 listed)
- Patient over 18 years admitted to the emergency department of Grenoble University Hospital
- No objection by the subject to the study
- Affiliated to the French social security system (or equivalent)
Key exclusion criteria (7 listed)
- Physical inability to collect BP at the admission in the emergency department (pain, arm wound)
- Technical inability to collect BP at the admission in the emergency department (incompatible size of the cuffs)
- Medical or surgical contraindication to repeated blood pressure measurement on both arms
- Patient who received antihypertensive treatment within the hour prior to measurements
- Unable to communicate or non-french speaking patients or those with impaired comprehension or consciousness
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 |
|---|---|---|
| Blood pressure measurementBlood pressure measurements in addition to the standard care at patients admitted in the Emergency department as follow: * 3 Blood pressure measurements on bare arm serving as control in accordance with the guidelines. * 3 Blood pressure measurements over sleeves of varying thicknesses (thin, thick, and canyon) | Other | Patient admitted in the Emergency Department |
Primary outcome
Differences between MAP measured over clothing and the average MAP measured on the bare arm
Time frame: 20 minutes
Differences between the mean arterial pressure (MAP) measured over clothing and the average MAP measured on the bare arm
4 secondary outcomes
Differences between MAP measured between the various layers of clothing.
Time frame: 20 minutes
Error rate between groups with sleeves compared with the control group
Time frame: 20 minutes
Difference in the mean of systolic blood pressure values measured between the groups with sleeves and the control group.
Time frame: 20 minutes
Difference of MAP measured between sleeves and control group in hypotensive patients
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor. In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.
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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.
JEREMY CHARLES, MD principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by University Hospital, Grenoble.
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: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JEREMY CHARLES, MD (0033476766784, PBordas@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between MAP measured over clothing and the average MAP measured on the bare arm (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.