Can we Improve Preoxygenation by Using Adjustable Pressure Limiting Valve (APL) ?
NCT ID: NCT04010279
Last Updated: 2019-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-07-09
2019-07-16
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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spontaneous breathing
volunteers will breath via an anesthesia face mask spontaneously while the APL (airway pressure release valve) valve is on the spontaneous position.
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%.
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.
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%.
CPAP 5cmH2O PEEP
volunteers will breath via an anesthesia face mask spontaneously on the CPAP mode of the anesthesia workstation with 5 cmH2O PEEP.
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%.
Interventions
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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%.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
ALL
Yes
Sponsors
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Kahramanmaras Sutcu Imam University
OTHER
Responsible Party
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MAHMUT ARSLAN
Assistant Professor
Locations
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Kahramanmaras Sutcu Imam University
Kahramanmaraş, In the USA Or Canada, Please Select..., Turkey (Türkiye)
KAhramanmaras Sutcu Imam University
Kahramanmaraş, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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KSU 2019-77
Identifier Type: -
Identifier Source: org_study_id
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