Blood PressureNCT03294928
Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers
A study testing progressive increasing of PEEP level. in people with Blood Pressure, run by University of Pisa at 1 site in Italy.
Trial summary
Population in study will be selected from students and staff of the University of Pisa. Right carotid artery contour wave analysis will be performed during the application of different PEEP levels (from 0 cmH2O to 10 cmH2O) with applanation tonometry technique. 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?
- progressive increasing of PEEP level.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 28 Sep 2017to 15 Oct 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 40, absence of any chronic diseases, no smoke, no drugs assumptions, no use of caffeine the day of the exam
Who cannot join
- pregnancy, chronic diseases, smokers, and intake of caffeine the day of the exam.
Trial locations and contacts
1 site in 1 country.
About this study
Population in study will be selected from students and staff of the University of Pisa. Right carotid artery contour wave analysis will be performed during the application of different PEEP levels (from 0 cmH2O to 10 cmH2O) with applanation tonometry technique.
- Conditions
- Blood Pressure
- Being tested
- progressive increasing of PEEP level.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive increasing of PEEP level.Other
four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level First step (Baseline) Subjects spontaneously breathe in air at atmospheric pressure during applanation tonometry.
Second step (PEEP=5 cm H2O) Applanation tonometry was performed during the application of PEEP = 5 cmH2O (Oxygen flow = 8lt.- Air flow = 10 lt.).
Third step (PEEP= 10 cm H2O) Applanation tonometry was performed during the application of PEEP = 10 cmH2O (Oxygen flow = 15lt.- Air flow = 20 lt.).
Fourth step (Recovery) Subjects spontaneously rebreathe air at atmospheric pressure during applanation tonometry.
| Study group | Role | What they receive |
|---|---|---|
| progressive increasing of PEEP level | Experimental | four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level. Receives: Other: progressive increasing of PEEP level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic variations in wave reflection induced by the application of increasing levels of PEEP in healthy subjects.
Mean blood pressure
Measured: at rest and after 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start28 Sep 2017
- Primary completion5 Oct 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Carlo Palombo, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294928
- Sponsor's protocol ID
- UPisa - 2017
- Status last verified
- Jan 2018
- First submitted
- 19 Sep 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Belfiore J, Brogi E, Nicolini N, Deffenu D, Forfori F, Palombo C. Hemodynamic variations in arterial wave reflection associated with the application of increasing levels of PEEP in healthy subjects. Sci Rep. 2022 Feb 28;12(1):3335. doi: 10.1038/s41598-022-07410-1.
PubMed 35228629
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03294928
- Acronym / sponsor ID
- UPisa - 2017
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 5 Oct 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 27 Sep 2017 (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.
Population in study will be selected from students and staff of the University of Pisa. Right carotid artery contour wave analysis will be performed during the application of different PEEP levels (from 0 cmH2O to 10 cmH2O) with applanation tonometry technique.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| progressive increasing of PEEP level | Experimental | Other: progressive increasing of PEEP level.four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age between 18 and 40, absence of any chronic diseases, no smoke, no drugs assumptions, no use of caffeine the day of the exam
Key exclusion criteria (1 listed)
- pregnancy, chronic diseases, smokers, and intake of caffeine the day of the exam.
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 |
|---|---|---|
| progressive increasing of PEEP level.four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level First step (Baseline) Subjects spontaneously breathe in air at atmospheric pressure during applanation tonometry. Second step (PEEP=5 cm H2O) Applanation tonometry was performed during the application of PEEP = 5 cmH2O (Oxygen flow = 8lt.- Air flow = 10 lt.). Third step (PEEP= 10 cm H2O) Applanation tonometry was performed during the application of PEEP = 10 cmH2O (Oxygen flow = 15lt.- Air flow = 20 lt.). Fourth step (Recovery) Subjects spontaneously rebreathe air at atmospheric pressure during applanation tonometry. | Other | progressive increasing of PEEP level |
Primary outcome
hemodynamic variations in wave reflection induced by the application of increasing levels of PEEP in healthy subjects.
Time frame: at rest and after 5 minutes
Mean blood pressure
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 5 Jan 2018.
- Derived from this study: PubMed 35228629Belfiore J, Brogi E, Nicolini N, Deffenu D, Forfori F, Palombo C. Hemodynamic variations in arterial wave reflection associated with the application of increasing levels of PEEP in healthy subjects. Sci Rep. 2022 Feb 28;12(1):3335. doi: 10.1038/s41598-022-07410-1.
Related trials for Blood Pressure
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruitingObservational study
Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables
Hypertension
RecruitingObservational study
Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
Blood Pressure Measurement
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive increasing of PEEP level. in people with Blood Pressure, run by University of Pisa at 1 site in Italy.
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 1 inclusion and 1 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 5 Jan 2018. 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 Italy. 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?
hemodynamic variations in wave reflection induced by the application of increasing levels of PEEP in healthy subjects. (time frame: at rest and after 5 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 NCT03294928, which also lists 1 linked publication.
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 5 Jan 2018.