NCT04010279

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Kahramanmaras Sutcu Imam University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Preoxygenation

Interventions

Type	Name	Description
PROCEDURE	preoxygenation with 100% O2, fresh gas flow rate 12 L/minute	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%.

Timeline

• Start date: 2019-07-09
• Primary completion: 2019-07-16
• Completion: 2019-07-16
• First posted: 2019-07-08
• Last updated: 2019-11-13

Locations

2 sites across 1 country: Turkey (Türkiye)