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

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).

Study Overview

• Status: Completed
• Conditions: Preoxygenation
• Intervention / Treatment: Procedure: preoxygenation with 100% O2, fresh gas flow rate 12 L/minute

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kahramanmaras, Turkey, 46100
    • Kahramanmaras Sutcu Imam University
  • In The USA Or Canada, Please Select...
    • Kahramanmaras, In The USA Or Canada, Please Select..., Turkey, 46100
      • Kahramanmaras Sutcu Imam University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• any respiratory disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: spontaneous breathing; volunteers will breath via an anesthesia face mask spontaneously while the APL (airway pressure release valve) valve is on the spontaneous position.	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%.
Active Comparator: spontaneous breathing with APL 5 cmH2O; volunteers will breath via an anesthesia face mask spontaneously while the APL (airway pressure release valve) valve is on the 5 cmH2O position.	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%.
Active Comparator: CPAP 5cmH2O PEEP; volunteers will breath via an anesthesia face mask spontaneously on the CPAP mode of the anesthesia workstation with 5 cmH2O PEEP.	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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time to reach end expiratory fraction of oxygen of 90% or more	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Publications and helpful links

General Publications

• Hanouz JL, Le Gall F, Gerard 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 Anaesth. 2018 Apr;120(4):868-873. doi: 10.1016/j.bja.2017.12.002. Epub 2018 Jan 17.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2019
• Primary Completion (Actual): July 16, 2019
• Study Completion (Actual): July 16, 2019

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: preoxygenation; CPAP(continuous positive airway pressure); APL (airway pressure release) valve
• Other Study ID Numbers: KSU 2019-77

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No