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

Preoxygenation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010279
• Other study ID #: KSU 2019-77
• Status: Completed
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: July 16, 2019

Study information

• Verified date: July 2019
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• any respiratory disease

Related Conditions & MeSH terms

• Preoxygenation

Intervention

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%.

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sutcu Imam University	Kahramanmaras	In The USA Or Canada, Please Select...
Turkey	KAhramanmaras Sutcu Imam University	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Hanouz JL, Le Gall F, Gérard JL, Terzi N, Normand H. Non-invasive positive-pressure ventilation with positive end-expiratory pressure counteracts inward air leaks during preoxygenation: a randomised crossover controlled study in healthy volunteers. Br J A — View Citation

Sreejit MS, Ramkumar V. Effect of positive airway pressure during pre-oxygenation and induction of anaesthesia upon safe duration of apnoea. Indian J Anaesth. 2015 Apr;59(4):216-21. doi: 10.4103/0019-5049.154998. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to reach end expiratory fraction of oxygen of 90% or more		5 minutes
Secondary	proportion of volunteer with end expiratory fraction of oxygen of 90% or more after a 3 min period		3 minutes
Secondary	End expiratory oxygen fraction at the 3th minute		3 minutes
Secondary	Verbal rating Score	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	5 minutes