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

Not Applicable

Completed

• Conditions: Preoxygenation
• Interventions: Procedure: preoxygenation with 100% O2, fresh gas flow rate 12 L/minute

• Registration Number: NCT04010279
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief 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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-05
• Study First Posted: 2019-07-08
• Study Start: 2019-07-09
• Primary Completion: 2019-07-16
• Study Completion: 2019-07-16
• Last Update Submitted: 2019-11-10
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

• any respiratory disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
spontaneous breathing	preoxygenation with 100% O2, fresh gas flow rate 12 L/minute	volunteers will breath via an anesthesia face mask spontaneously while the APL (airway pressure release valve) valve is on the spontaneous position.
CPAP 5cmH2O PEEP	preoxygenation with 100% O2, fresh gas flow rate 12 L/minute	volunteers will breath via an anesthesia face mask spontaneously on the CPAP mode of the anesthesia workstation with 5 cmH2O PEEP.
spontaneous breathing with APL 5 cmH2O	preoxygenation with 100% O2, fresh gas flow rate 12 L/minute	volunteers will breath via an anesthesia face mask spontaneously while the APL (airway pressure release valve) valve is on the 5 cmH2O position.

Primary Outcome Measures

Name	Time	Method
time to reach end expiratory fraction of oxygen of 90% or more	5 minutes

Secondary Outcome Measures

Name	Time	Method
Verbal rating Score	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
proportion of volunteer with end expiratory fraction of oxygen of 90% or more after a 3 min period	3 minutes
End expiratory oxygen fraction at the 3th minute	3 minutes

Trial Locations

Locations (2)

Kahramanmaras Sutcu Imam University; 🇹🇷 Kahramanmaras, In The USA Or Canada, Please Select..., Turkey

KAhramanmaras Sutcu Imam University; 🇹🇷 Kahramanmaras, Turkey