Completed

The Effects of Setting Adjustable Pressure Limiting Valve (APL) to 5 cmH2O on Preoxygenation

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What is being tested

preoxygenation with 100% O2, fresh gas flow rate 12 L/minute

Procedure
Who is being recruted

From 18 to 40 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: July 2019
See protocol details

Summary

Principal SponsorKahramanmaras Sutcu Imam University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 9, 2019

Actual date on which the first participant was enrolled.

There are several methods to improve preoxygenation but most of them require advanced anesthesia workstations. Therefore the investigators planned an an experimental study on healthy volunteers to investigate the effects of a simple method on preoxygenation. Healthy volunteers are randomized in cross-over between spontaneous breathing with the APL valve on spontaneous position or spontaneous breathing with the APL valve on 5 cmH2O or CPAP mode with 5 cmH2O PEEP. The volunteers will breath through an anesthesia face mask. The fresh gas flow rate is 12 L/min, inspiratory fraction of oxygen is 100%. The exhaled gas (oxygen and carbon dioxide) are monitored. The inspiratory and end expiratory fraction of oxygen will be recorded every 10 seconds. The primary endpoint is the time to achieve end expiratory fraction of oxygen of 90% or more.The secondary endpoint is the proportion of subject with end expiratory fraction of oxygen of 90% or more after a 3 min period and the end expiratory fraction of oxygen at the third minute.

Official TitleThe Effects of Setting Adjustable Pressure Limiting Valve (APL) to 5 cmH2O on Preoxygenation
NCT04010279
Principal SponsorKahramanmaras Sutcu Imam University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
healthy volunteers

1 exclusion criteria prevent from participating
any respiratory disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
volunteers will breath via an anesthesia face mask spontaneously on the CPAP mode of the anesthesia workstation with 5 cmH2O PEEP.

Group II

Active Comparator
volunteers will breath via an anesthesia face mask spontaneously while the APL (airway pressure release valve) valve is on the spontaneous position.

Group III

Active Comparator
volunteers will breath via an anesthesia face mask spontaneously while the APL (airway pressure release valve) valve is on the 5 cmH2O position.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)Open Kahramanmaras Sutcu Imam University in Google Maps
Suspended

KAhramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)
Completed2 Study Centers
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