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Completed

NCT Number: NCT04010279

Can we Improve Preoxygenation by Using Adjustable Pressure Limiting Valve (APL) ?

The aim of this study is to investigate the effects of setting airway pressure release valve (APL valve) on the anesthesia workstation to 5 cmH2O during spontaneous breathing on preoxygenation. In this prospective study 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 (continous positive airway pressure) mode with 5 cmH2O PEEP (positive end expiratory pressure).

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Key information

Conditions

Preoxygenation

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaras Sutcu Imam University, Kahramanmaraş, In the USA Or Canada, Please Select..., Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers

Exclusion criteria

  • any respiratory disease

Treatment and study plan

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

Procedure

volunteers will be placed in supine position, fresh gas flow rate will be set at 12 L/min and delivered oxygen concentration will be set at 100%.

Primary outcomes

  1. time to reach end expiratory fraction of oxygen of 90% or more

    Time frame: 5 minutes

Secondary outcomes

  1. proportion of volunteer with end expiratory fraction of oxygen of 90% or more after a 3 min period

    Time frame: 3 minutes

  2. End expiratory oxygen fraction at the 3th minute

    Time frame: 3 minutes

  3. Verbal rating Score

    Time frame: 5 minutes

    After completion of the whole arms of the study the volunteers will give a score between 0-10 to define the difficulty of breathing during the procedure

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2019
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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