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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spontaneous breathing | Active Comparator | volunteers will breath via an anesthesia face mask spontaneously while the APL (airway pressure release valve) valve is on the spontaneous position. |
|
| spontaneous breathing with APL 5 cmH2O | Active Comparator | volunteers will breath via an anesthesia face mask spontaneously while the APL (airway pressure release valve) valve is on the 5 cmH2O position. |
|
| CPAP 5cmH2O PEEP | Active Comparator | volunteers will breath via an anesthesia face mask spontaneously on the CPAP mode of the anesthesia workstation with 5 cmH2O PEEP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| time to reach end expiratory fraction of oxygen of 90% or more | 5 minutes |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kahramanmaras Sutcu Imam University | Kahramanmaraş | In the USA Or Canada, Please Select... | 46100 | Turkey (Türkiye) | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29576128 | Result | 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. | |
| 25937647 |
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| 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 |
| KAhramanmaras Sutcu Imam University |
| Kahramanmaraş |
| 46100 |
| Turkey (Türkiye) |
| 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. |