Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers

Blood Pressure Clinical Trial

Official title:

Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294928
• Other study ID #: UPisa - 2017
• Status: Completed
• Phase: N/A
• First received: September 19, 2017
• Last updated: January 4, 2018
• Start date: September 28, 2017
• Est. completion date: October 15, 2017

Study information

• Verified date: January 2018
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 15, 2017
• Est. primary completion date: October 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age between 18 and 40, absence of any chronic diseases, no smoke, no drugs assumptions, no use of caffeine the day of the exam

Exclusion Criteria:

• pregnancy, chronic diseases, smokers, and intake of caffeine the day of the exam.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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 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.

Locations

Country	Name	City	State
Italy	University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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