Blood PressurePA-SpeleoNCT07843160
Blood Pressure Measured on the Arm : Bare Arm Versus a Speleological Suit Sleeve in Patients From Grenoble Alpes University Hospital
An observational study of Blood Pressure, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Blood pressure (BP) is an essential physiological parameter for assessing patient condition. In pre-hospital emergency situations it is measured on the arm over the clothes of the patient, who 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
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2026to 21 Dec 2026
- 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: Adult patient (male and female) admitted in the Emergency Department of Grenoble University Hospital will have several series of blood pressure measurement .
Who may be able to join
- Patient over 18 years admitted to the emergency department of Grenoble University Hospital
- National health insurance coverage or an equivalent form of coverage
Who cannot join
- Physical or technical inability to collect BP upon the patient's admission at ED (wounds or trauma to the arms)
- Technical impossibility to set up the tested sleeve (incompatible arm size)
- Patient with a medical contraindication to repeated blood pressure measurements on both arms
- Patient who received antihypertensive treatment within the hour prior to measurements
- Staff with hierarchical family or friendly ties to the principal investigator
- Inability to provide informed consent because of impaired communication in French
Show all 9Show fewer
- Persons covered by Articles L1121-5 to L1121-8 of the Public Health Code
- The patient already enrolled in the study
- Objection by the subject to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Grenoble University Hospital
Grenoble, Autre
MAEL LEPOUPON, MD, 0033476766784, mlepoupon@chu-grenoble.fr
Prudence MABIALA MAKELE, PhD, 0033476766784, pmabialamakele@chu-grenoble.fr
About this study
Official title: Blood Pressure Measured on the Arm : Bare Arm Versus a Speleological Suit Sleeve in Patients From Grenoble Alpes University Hospital (PA- COUCHE Speleo)
Blood pressure (BP) is an essential physiological parameter for assessing patient condition. In pre-hospital emergency situations it is measured on the arm over the clothes of the patient, who cannot be undressed.
There is no study proving the reliability of this measurement compared to measurement according to the 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 study is to assess variations in blood pressure measurements based on the layer of the patient's technical caving clothing 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 :
- 3 measurements of blood pressure on a bare arm being the reference value corresponding to the recommendations on taking blood pressure
- 3 measurements of blood pressure over a speleological (caving) suit sleeve
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 SCHILLER blood pressure monitoring 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 significant difference between the MAP measured over a speleological suit sleeve and that measured on a bare arm.
The speleological suit sleeve will be provided by the investigator and will remain the same throughout the study
- Conditions
- Blood Pressure
- Being tested
- Blood pressure measurement
- Keywords
- Blood Pressure measurement, Bar Arm, Speleological suit 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 measurements of blood pressure on a bare arm being the reference value corresponding to the recommendations on taking blood pressure.
- 3 measurements of blood pressure over a speleological (caving) suit sleeve
| Study group | Role | What they receive |
|---|---|---|
| Patient admitted in the Emergency Department | Patient admitted in the Emergency Department Adult patient admitted in the Emergency Department of Grenoble University Hospital will have several series of blood pressure measurement (6 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.
Difference between the mean of the MAP measured with a sleeve and the mean of the MAP measured on a bare arm
Difference between the mean of the Mean Arterial Pressures (MAP) measured with a sleeve and the mean of the MAP measured on a bare arm.
Measured: 20 minutes
Secondary outcomes (2)
Difference between the mean of the SBP measurements taken over a speleological (caving) suit sleeve compared to the bare arm
Difference between the mean of the Systolic Blood Pressure (SBP) measurements taken over a speleological (caving) suit sleeve compared to the bare arm
Measured: 20 minutes
Difference between the mean of the MAP measurements taken with a sleeve and the mean of the MAP measurements taken on the bare arm in a subgroup of hypotensive patients
Difference between the mean of the Mean Arterial Pressure (MAP) measurements taken with a sleeve and the mean of the MAP measurements taken on the bare arm in a subgroup of 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 posted25 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion21 Nov 2026 (estimated)
- Study completion21 Dec 2026 (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
- 20 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, GrenobleMAEL LEPOUPON, MD, Study director, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843160
- Sponsor's protocol ID
- 38RC26.0264
- Other IDs
- IDRCB :2026-A01612-49
- Acronym
- PA-Speleo
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 25 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Measured on the Arm : Bare Arm Versus a Speleological Suit Sleeve in Patients From Grenoble Alpes University Hospital (PA- COUCHE Speleo)
- ClinicalTrials.gov ID
- NCT07843160
- Acronym / sponsor ID
- PA-Speleo / 38RC26.0264
- Conditions
- Blood Pressure
- Keywords
- Blood Pressure measurement, Bar Arm, Speleological suit sleeve
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 21 Nov 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 25 Sep 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 on the arm over the clothes of the patient, who cannot be undressed.
There is no study proving the reliability of this measurement compared to measurement according to the 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 study is to assess variations in blood pressure measurements based on the layer of the patient's technical caving clothing 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 :
- 3 measurements of blood pressure on a bare arm being the reference value corresponding to the recommendations on taking blood pressure
- 3 measurements of blood pressure over a speleological (caving) suit sleeve
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 SCHILLER blood pressure monitoring 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 significant difference between the MAP measured over a speleological suit sleeve and that measured on a bare arm.
The speleological suit sleeve will be provided by the investigator 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 measurementPatient admitted in the Emergency Department Adult patient admitted in the Emergency Department of Grenoble University Hospital will have several series of blood pressure measurement (6 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
- Adult patient (male and female) admitted in the Emergency Department of Grenoble University Hospital will have several series of blood pressure measurement .
Key inclusion criteria (2 listed)
- Patient over 18 years admitted to the emergency department of Grenoble University Hospital
- National health insurance coverage or an equivalent form of coverage
Key exclusion criteria (9 listed)
- Physical or technical inability to collect BP upon the patient's admission at ED (wounds or trauma to the arms)
- Technical impossibility to set up the tested sleeve (incompatible arm size)
- Patient with a medical contraindication to repeated blood pressure measurements on both arms
- Patient who received antihypertensive treatment within the hour prior to measurements
- Staff with hierarchical family or friendly ties to the principal investigator
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 measurements of blood pressure on a bare arm being the reference value corresponding to the recommendations on taking blood pressure. * 3 measurements of blood pressure over a speleological (caving) suit sleeve | Other | Patient admitted in the Emergency Department |
Primary outcome
Difference between the mean of the MAP measured with a sleeve and the mean of the MAP measured on a bare arm
Time frame: 20 minutes
Difference between the mean of the Mean Arterial Pressures (MAP) measured with a sleeve and the mean of the MAP measured on a bare arm.
2 secondary outcomes
Difference between the mean of the SBP measurements taken over a speleological (caving) suit sleeve compared to the bare arm
Time frame: 20 minutes
Difference between the mean of the MAP measurements taken with a sleeve and the mean of the MAP measurements taken on the bare arm in a subgroup of 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 25 Sep 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.
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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
MAEL LEPOUPON, MD study director
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by University Hospital, Grenoble 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 9 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 25 Sep 2026. 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?
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 MAEL LEPOUPON, MD (0033476766784, mlepoupon@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the mean of the MAP measured with a sleeve and the mean of the MAP measured on a 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 25 Sep 2026.