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

NCT04010279 | Completed

• 1 other identifier: KSU 2019-77
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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).

Conditions

Preoxygenation

Keywords

preoxygenation; CPAP(continuous positive airway pressure); APL (airway pressure release) valve

Outcome Measures

Primary Outcomes (1)

• time to reach end expiratory fraction of oxygen of 90% or more

  5 minutes

Secondary Outcomes (3)

• 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

• Verbal rating Score

  5 minutes

Study Arms (3)

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.

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

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.

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

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.

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

Interventions

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%.

CPAP 5cmH2O PEEP; spontaneous breathing; spontaneous breathing with APL 5 cmH2O

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers

You may not qualify if:

• any respiratory disease

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (2)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, In the USA Or Canada, Please Select..., 46100, Turkey (Türkiye)

Location

KAhramanmaras Sutcu Imam University

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 29576128 RESULT

• 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.

  PMID: 25937647 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: July 9, 2019
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-07

Locations

TU (2)