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

January 4, 2018 updated by: Prof. Carlo Palombo, University of Pisa
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56100
        • University of Pisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: progressive increasing of PEEP level
four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at rest and after 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2017

Primary Completion (Actual)

October 5, 2017

Study Completion (Actual)

October 15, 2017

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 27, 2017

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • UPisa - 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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