Blood PressureVALPARAISONCT02529735
Study on Pressure Values Measured on Three Alternative Sites of the Lower Limbs Compared to the Arm
A study testing efficiency study in people with Blood Pressure, run by Centre Hospitalier Sud Francilien at 8 sites in France.
Trial summary
Non-invasive measurement of blood pressure is an instrument governed nursing routine care. The use of an automated oscillometric cuff is a common technique and validated if this is done on the arm with a suitable cuff, positioned opposite the brachial artery and up to the right atrium (the brachial site) . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- efficiency study
- How many people
- Not given
- Where
- 8 sitesFrance
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 and over, without upper age limit
- Recipient of a social protection scheme or entitled
- Signature of informed consent
Who cannot join
- During Pregnancy
- known disease
- current treatment
- cardiovascular history
- Skin lesions in relation to the measurement sites
- Special anatomically incompatible with blood pressure measurements
Show all 9Show fewer
- No one opposing the use of their data
- Participation in a trial Ongoing clinical
- Person who participated in the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
- Available
Sud Francilien Nursing School
Corbeil-Essonnes, 91100
Elisabeth Hermes, RN, +33161696615, elisabeth.hermes@chsf.fr
- Available
Perray-Vaucluse Nursing School
Épinay-sur-Orge, 91360
Christine Kaci, RN, +33169254446, c.kaci@gpspv.fr
- Available
Nursing Scool Barthelemy Durand
Étampes, 91150
Nathalie Lecoq, RN, +33169925148, nathalie.lecoq@eps-etampes.fr
- Available
SSSM of Essonne SDIS91
Évry, 91000
Frédéric Bonnet, RN, +33178054600, fbonnet@sdis91.fr
- Available
Nursing School of Longjumeau
Longjumeau, 91160
Nadine Ankri, RN, +33164543281, n.ankri@gh-nord-essonne.fr
- Available
Nursing School Tenon
Paris, 75020
Nathalie Thevenot, RN, +33143799200, nathalie.thevenot@aphp.fr
- Available
Nursing School Rambouillet
Rambouillet, 78120
Evelyne Berdagué, RN, +33134837759, e.berdague@chrambouillet.fr
- Available
Nursing School Foch
Suresnes, 92151
Marie-Ange Saget, RN, +33146252185, ma.saget@hopital-foch.com
About this study
Official title: Etude Prospective Observationnelle Multicentrique Sur Volontaires Sains Des VALeurs de Pression Artérielle mesurées Sur Trois Sites alteRnAtIfS Des Membres inférieurs cOmparées au Site de référence
Non-invasive measurement of blood pressure is an instrument governed nursing routine care. The use of an automated oscillometric cuff is a common technique and validated if this is done on the arm with a suitable cuff, positioned opposite the brachial artery and up to the right atrium (the brachial site) . If cons-indication to use the brachial site, measurements are frequently performed at the ankle, calf or thigh. Among the blood pressure values measured on the 3 sites of the lower limb (thigh, calf or ankle), it may be a specific property of which the observed values are closest to the reference values (brachial).
The objective of this study is to measure the non-invasive blood pressure values at three sites of the lower limb, to compare the reference value to determine which alternative site should be preferred when the reference measurement is not feasible .
Read more
We want to determine the alternative site to obtain values as close as the measured values of the reference site. The three study sites are the thigh, calf and ankle. The reference site recommended for monitoring non-invasive blood pressureis the arm.
It is also assessing the impact of certain parameters on the primary endpoint:
- Physiological parameters: gender, weight, height, age, systolic blood pressure reference, listed measures.
- A parameter related to measurement: discomfort felt when the blood pressure outlet.
- Exposure setting: smoking.
Read the detailed description
Primary Outcome: The difference in systolic blood pressure, diastolic and mean simultaneously measured in the arm and each of the three sites in the lower limb.
Secondary endpoints: The difference in systolic blood pressure, diastolic and mean simultaneously measured in the arm and each of the three sites in the lower limb in the following subgroups:
- Male / Female
- BMI <25 / BMI> 25
- Size < 160 cm / size [160-169] cm / size [170-180] cm / size [181-190] cm / size ≥ 191 cm
- Age <25 years / age ≥ 25 years
- Systolic Blood Pressure value (SAP) the reference site <100 mmHg / 100 mmHg and ≥ NOT value of the reference site <140 mmHg / ≥ 140 mmHg
- Visual Analog Scale of discomfort ≤ 4/10 /> 4/10
- Hemibody studied Right / Left
- Smoking / No Smoking
Discomfort level depending on the measurement site of blood pressure in the general population.
- Discomfort level for each measurement of blood pressure site in each of the following subgroups:
- Male / Female - BMI <25 / BMI> 25
- size <160 cm / size [160-169] cm / size [170 -180] cm / size [181-190] cm / size ≥ 191 cm - Age <25 / age ≥ 25 years
- blood pressure value (SAP) reference site <100 mmHg / 100 mmHg and ≥ NOT Value reference site <140 mmHg / ≥ 140 mmHg
- hemibody studied Right / Left
- Smoking / No Smoking
Methodology:
Experimental design:
This is an observational study, prospective, multicenter, comparative on healthy volunteers, each individual is his own witness. Reports of non-invasive blood pressure values of 3 different sites of the lower limbs, compared to a reference value. For each individual, the side which will be carried out blood pressure measurements will be drawn. After 5 minutes rest in the supine position, it will be realized the measurement of blood pressure non-invasively systolic, mean and diastolic 2 automated oscillometric measuring devices identical and calibrated simultaneously the arm and thigh ipsilateral / arm and calf ipsilateral / arm and the ipsilateral ankle.
Each measurement is repeated once after 1 minute.
Statistical analysis:
Systolic, mean and diastolic pressures are analyzed separately, and expressed by their average with standard deviation and 95% confidence intervals. The concordance of BP measurements between the arm and each of three sites in the lower limb was analyzed by the method Bland and Altman, calculating the average difference, its approval limits, as well as the confidence interval 95 % upper and lower limits of approval subject to a Gaussian distribution of the difference between the measurements.
The search for the best AP measurement site to the lower member is made by comparing the differences between each of the three sites and the reference site, for a global test (variance analysis or test Friedmann according to the distribution of differences), then by comparisons with 2-2 adjusting the p-value.
The chosen site is one for which this difference is significantly weaker. All tests are conducted bilaterally with a risk of first species set at 5%. In an earlier study, the largest variance found regarding the difference in systolic BP between calf and arm.
Based on the most pessimistic scenario (s = 12.76) to highlight a difference of 5 mm Hg with an alpha risk of 5% and a power of 90% and taking into account the multiple comparisons considered, 176 patients necessary.
Total duration of study: 27 months Period of inclusion: 24 months Duration of participation for voluntary: 30 minutes Number of participating centers: 8 centers
- Conditions
- Blood Pressure
- Being tested
- efficiency study
- Keywords
- blood pressure, alternative measure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efficiency studyOther
Blood pressure values measured for comparative lower limb and arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Lagadec, Centre Hospitalier Sud Francilien
- Investigators
- Steven Lagadec, RN, Study director, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529735
- Sponsor's protocol ID
- CHSFrancilien
- Acronym
- VALPARAISO
- Status last verified
- Oct 2019
- First submitted
- 19 Aug 2015
- Last updated
- 21 Oct 2019
- Results posted
- No
Publications
Chatterjee A, DePriest K, Blair R, Bowton D, Chin R. Results of a survey of blood pressure monitoring by intensivists in critically ill patients: a preliminary study. Crit Care Med. 2010 Dec;38(12):2335-8. doi: 10.1097/CCM.0b013e3181fa057f.
PubMed 20890190Block FE, Schulte GT. Ankle blood pressure measurement, an acceptable alternative to arm measurements. Int J Clin Monit Comput. 1996 Aug;13(3):167-71. doi: 10.1023/a:1016997232542.
PubMed 8912031Sanghera S, North A, Abernethy S, Wrench I. Arm and ankle blood pressure during caesarean section. Int J Obstet Anesth. 2006 Jan;15(1):24-7. doi: 10.1016/j.ijoa.2005.04.016. Epub 2005 Oct 26.
PubMed 16256340Moore C, Dobson A, Kinagi M, Dillon B. Comparison of blood pressure measured at the arm, ankle and calf. Anaesthesia. 2008 Dec;63(12):1327-31. doi: 10.1111/j.1365-2044.2008.05633.x.
PubMed 19032301Lakhal K, Macq C, Ehrmann S, Boulain T, Capdevila X. Noninvasive monitoring of blood pressure in the critically ill: reliability according to the cuff site (arm, thigh, or ankle). Crit Care Med. 2012 Apr;40(4):1207-13. doi: 10.1097/CCM.0b013e31823dae42.
PubMed 22425818
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Prospective Observationnelle Multicentrique Sur Volontaires Sains Des VALeurs de Pression Artérielle mesurées Sur Trois Sites alteRnAtIfS Des Membres inférieurs cOmparées au Site de référence
- ClinicalTrials.gov ID
- NCT02529735
- Acronym / sponsor ID
- VALPARAISO / CHSFrancilien
- Conditions
- Blood Pressure
- Keywords
- blood pressure, alternative measure
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- First posted
- 20 Aug 2015 (estimated)
- 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.
Non-invasive measurement of blood pressure is an instrument governed nursing routine care. The use of an automated oscillometric cuff is a common technique and validated if this is done on the arm with a suitable cuff, positioned opposite the brachial artery and up to the right atrium (the brachial site) . If cons-indication to use the brachial site, measurements are frequently performed at the ankle, calf or thigh. Among the blood pressure values measured on the 3 sites of the lower limb (thigh, calf or ankle), it may be a specific property of which the observed values are closest to the reference values (brachial).
The objective of this study is to measure the non-invasive blood pressure values at three sites of the lower limb, to compare the reference value to determine which alternative site should be preferred when the reference measurement is not feasible .
We want to determine the alternative site to obtain values as close as the measured values of the reference site. The three study sites are the thigh, calf and ankle. The reference site recommended for monitoring non-invasive blood pressureis the arm.
It is also assessing the impact of certain parameters on the primary endpoint:
- Physiological parameters: gender, weight, height, age, systolic blood pressure reference, listed measures.
- A parameter related to measurement: discomfort felt when the blood pressure outlet.
- Exposure setting: smoking.
Detailed description
Primary Outcome: The difference in systolic blood pressure, diastolic and mean simultaneously measured in the arm and each of the three sites in the lower limb.
Secondary endpoints: The difference in systolic blood pressure, diastolic and mean simultaneously measured in the arm and each of the three sites in the lower limb in the following subgroups:
- Male / Female
- BMI <25 / BMI> 25
- Size < 160 cm / size [160-169] cm / size [170-180] cm / size [181-190] cm / size ≥ 191 cm
- Age <25 years / age ≥ 25 years
- Systolic Blood Pressure value (SAP) the reference site <100 mmHg / 100 mmHg and ≥ NOT value of the reference site <140 mmHg / ≥ 140 mmHg
- Visual Analog Scale of discomfort ≤ 4/10 /> 4/10
- Hemibody studied Right / Left
- Smoking / No Smoking
Discomfort level depending on the measurement site of blood pressure in the general population.
- Discomfort level for each measurement of blood pressure site in each of the following subgroups:
- Male / Female - BMI <25 / BMI> 25
- size <160 cm / size [160-169] cm / size [170 -180] cm / size [181-190] cm / size ≥ 191 cm - Age <25 / age ≥ 25 years
- blood pressure value (SAP) reference site <100 mmHg / 100 mmHg and ≥ NOT Value reference site <140 mmHg / ≥ 140 mmHg
- hemibody studied Right / Left
- Smoking / No Smoking
Methodology:
Experimental design:
This is an observational study, prospective, multicenter, comparative on healthy volunteers, each individual is his own witness. Reports of non-invasive blood pressure values of 3 different sites of the lower limbs, compared to a reference value. For each individual, the side which will be carried out blood pressure measurements will be drawn. After 5 minutes rest in the supine position, it will be realized the measurement of blood pressure non-invasively systolic, mean and diastolic 2 automated oscillometric measuring devices identical and calibrated simultaneously the arm and thigh ipsilateral / arm and calf ipsilateral / arm and the ipsilateral ankle.
Each measurement is repeated once after 1 minute.
Statistical analysis:
Systolic, mean and diastolic pressures are analyzed separately, and expressed by their average with standard deviation and 95% confidence intervals. The concordance of BP measurements between the arm and each of three sites in the lower limb was analyzed by the method Bland and Altman, calculating the average difference, its approval limits, as well as the confidence interval 95 % upper and lower limits of approval subject to a Gaussian distribution of the difference between the measurements.
The search for the best AP measurement site to the lower member is made by comparing the differences between each of the three sites and the reference site, for a global test (variance analysis or test Friedmann according to the distribution of differences), then by comparisons with 2-2 adjusting the p-value.
The chosen site is one for which this difference is significantly weaker. All tests are conducted bilaterally with a risk of first species set at 5%. In an earlier study, the largest variance found regarding the difference in systolic BP between calf and arm.
Based on the most pessimistic scenario (s = 12.76) to highlight a difference of 5 mm Hg with an alpha risk of 5% and a power of 90% and taking into account the multiple comparisons considered, 176 patients necessary.
Total duration of study: 27 months Period of inclusion: 24 months Duration of participation for voluntary: 30 minutes Number of participating centers: 8 centers
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 and over, without upper age limit
- Recipient of a social protection scheme or entitled
- Signature of informed consent
Key exclusion criteria (9 listed)
- During Pregnancy
- known disease
- current treatment
- cardiovascular history
- Skin lesions in relation to the measurement sites
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 |
|---|---|---|
| efficiency studyBlood pressure values measured for comparative lower limb and arm | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Results publication: PubMed 20890190Chatterjee A, DePriest K, Blair R, Bowton D, Chin R. Results of a survey of blood pressure monitoring by intensivists in critically ill patients: a preliminary study. Crit Care Med. 2010 Dec;38(12):2335-8. doi: 10.1097/CCM.0b013e3181fa057f.
- Results publication: PubMed 8912031Block FE, Schulte GT. Ankle blood pressure measurement, an acceptable alternative to arm measurements. Int J Clin Monit Comput. 1996 Aug;13(3):167-71. doi: 10.1023/a:1016997232542.
- Results publication: PubMed 16256340Sanghera S, North A, Abernethy S, Wrench I. Arm and ankle blood pressure during caesarean section. Int J Obstet Anesth. 2006 Jan;15(1):24-7. doi: 10.1016/j.ijoa.2005.04.016. Epub 2005 Oct 26.
- Results publication: PubMed 19032301Moore C, Dobson A, Kinagi M, Dillon B. Comparison of blood pressure measured at the arm, ankle and calf. Anaesthesia. 2008 Dec;63(12):1327-31. doi: 10.1111/j.1365-2044.2008.05633.x.
- Results publication: PubMed 22425818Lakhal K, Macq C, Ehrmann S, Boulain T, Capdevila X. Noninvasive monitoring of blood pressure in the critically ill: reliability according to the cuff site (arm, thigh, or ankle). Crit Care Med. 2012 Apr;40(4):1207-13. doi: 10.1097/CCM.0b013e31823dae42.
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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.
Steven Lagadec, RN study director
Centre Hospitalier Sud Francilien
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing efficiency study in people with Blood Pressure, run by Centre Hospitalier Sud Francilien at 8 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 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: status not confirmed, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elodie Henry, CRU manager (+33161693730, elodie.henry@chsf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529735, which also lists 5 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 21 Oct 2019.