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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010279
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
MAHMUT ARSLAN, Kahramanmaras Sutcu Imam University

Brief 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).

Condition or disease Intervention/treatment Phase
Preoxygenation Procedure: preoxygenation with 100% O2, fresh gas flow rate 12 L/minute Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Setting Adjustable Pressure Limiting Valve (APL) to 5 cmH2O on Preoxygenation
Actual Study Start Date : July 9, 2019
Actual Primary Completion Date : July 16, 2019
Actual Study Completion Date : July 16, 2019

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%.




Primary Outcome Measures :
  1. time to reach end expiratory fraction of oxygen of 90% or more [ Time Frame: 5 minutes ]

Secondary Outcome Measures :
  1. proportion of volunteer with end expiratory fraction of oxygen of 90% or more after a 3 min period [ Time Frame: 3 minutes ]
  2. End expiratory oxygen fraction at the 3th minute [ Time Frame: 3 minutes ]
  3. Verbal rating Score [ Time Frame: 5 minutes ]
    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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • any respiratory disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010279


Locations
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Turkey
Kahramanmaras Sutcu Imam University
Kahramanmaras, In The USA Or Canada, Please Select..., Turkey, 46100
KAhramanmaras Sutcu Imam University
Kahramanmaras, Turkey, 46100
Sponsors and Collaborators
Kahramanmaras Sutcu Imam University
Publications of Results:
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Responsible Party: MAHMUT ARSLAN, Assistant Professor, Kahramanmaras Sutcu Imam University
ClinicalTrials.gov Identifier: NCT04010279    
Other Study ID Numbers: KSU 2019-77
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MAHMUT ARSLAN, Kahramanmaras Sutcu Imam University:
preoxygenation
CPAP(continuous positive airway pressure)
APL (airway pressure release) valve