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

K

Kahramanmaraş Sütçü İmam University (KSU)

Status

Completed

Conditions

Preoxygenation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04010279
KSU 2019-77

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy volunteers

Exclusion criteria

  • any respiratory disease

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 3 patient groups

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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