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

NCT ID: NCT03294928

Last Updated: 2018-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-28

Study Completion Date

2017-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

progressive increasing of PEEP level

four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level.

Group Type EXPERIMENTAL

progressive increasing of PEEP level.

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pisa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Carlo Palombo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pisa

Pisa, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35228629 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UPisa - 2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.