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

• Sponsor: Kahramanmaras Sutcu Imam University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04010279
• Collaborator: (none)
• Enrollment: 20
• Locations: 2
• Arms: 3
• Actual Duration (Days): 7
• Patients Per Site: 10
• Patients Per Site Per Month: 43.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jul 9, 2019
• Actual Primary Completion Date: Jul 16, 2019
• Actual Study Completion Date: Jul 16, 2019

Arms and Interventions

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%.

Outcome Measures

Primary Outcome Measures

1. time to reach end expiratory fraction of oxygen of 90% or more [5 minutes]

Secondary Outcome Measures

1. proportion of volunteer with end expiratory fraction of oxygen of 90% or more after a 3 min period [3 minutes]

2. End expiratory oxygen fraction at the 3th minute [3 minutes]

3. Verbal rating Score [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• any respiratory disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kahramanmaras Sutcu Imam University	Kahramanmaras	In The USA Or Canada, Please Select...	Turkey	46100
2	KAhramanmaras Sutcu Imam University	Kahramanmaras		Turkey	46100

Sponsors and Collaborators

• Kahramanmaras Sutcu Imam University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MAHMUT ARSLAN, Assistant Professor, Kahramanmaras Sutcu Imam University
• ClinicalTrials.gov Identifier: NCT04010279
• Other Study ID Numbers: KSU 2019-77
• First Posted: Jul 8, 2019
• Last Update Posted: Nov 13, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by MAHMUT ARSLAN, Assistant Professor, Kahramanmaras Sutcu Imam University: preoxygenation; CPAP(continuous positive airway pressure); APL (airway pressure release) valve

Study Results

No Results Posted as of Nov 13, 2019