Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers
1 other identifier
interventional
62
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2017
CompletedFirst Posted
Study publicly available on registry
September 27, 2017
CompletedStudy Start
First participant enrolled
September 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2017
CompletedJanuary 5, 2018
January 1, 2018
7 days
September 19, 2017
January 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
hemodynamic variations in wave reflection induced by the application of increasing levels of PEEP in healthy subjects.
Mean blood pressure
at rest and after 5 minutes
Study Arms (1)
progressive increasing of PEEP level
EXPERIMENTALfour-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level.
Interventions
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.
Eligibility Criteria
You may qualify if:
- age between 18 and 40, absence of any chronic diseases, no smoke, no drugs assumptions, no use of caffeine the day of the exam
You may not qualify if:
- pregnancy, chronic diseases, smokers, and intake of caffeine the day of the exam.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pisa
Pisa, 56100, Italy
Related Publications (1)
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.
PMID: 35228629DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 19, 2017
First Posted
September 27, 2017
Study Start
September 28, 2017
Primary Completion
October 5, 2017
Study Completion
October 15, 2017
Last Updated
January 5, 2018
Record last verified: 2018-01