A Novel Method of Preoxygenation Using a Bain Circuit

Healthy Volunteers Clinical Trial

Official title:

A Novel Method of Preoxygenation Using Partial Rebreathing Via a Coaxial Mapleson D Breathing System (Bain Circuit)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00958178
• Other study ID #: 08/S071038
• Status: Recruiting
• Phase: Phase 4
• First received: August 12, 2009
• Last updated: August 12, 2009
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2009
• Source: National Health Service, United Kingdom
• Contact: John Glen, MBChB; BSc
• Phone: +44(0)1414231465
• Email: johnglen[@]doctors.org.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether rebreathing for a short time (a bit like breathing into a paper bag) will stimulate faster breathing and thus make the giving of Oxygen more effective.

The hypothesis is that the investigators method (rebreathing) will be faster than the current method of administering Oxygen.

Description:

It is standard practice for patients to breathe oxygen before receiving a general anaesthetic. This is called preoxygenation. It is done by using a mask which fits snugly onto the face. But for how long should patients breathe oxygen? Is taking deep breaths a good idea? What is the best oxygen flow rate? These questions are important because preoxygenation is one of the things which makes anaesthesia safe, so finding the best way of doing it might help save lives. Previous research has attempted to identify the best way to give oxygen before anaesthesia. It seems that breathing pure oxygen for three minutes is enough, or if you are in an urgent situation, then taking deep breaths of pure oxygen for a minute will do. However, there is another possible way of doing it which has not yet been looked at.

Asking someone to breathe back in the air they have just exhaled seems, on the face of it, to be pointless at best. But doing just that for a very short time will make the person breathe harder. Then when you give them pure oxygen, they will breathe it in really deeply and this might make the preoxygenation quicker. That's the theory. To test it we plan to ask 40 healthy people to do the standard preoxygenation, then try our new way. We won't be giving anaesthetic, just the oxygen.

The hypothesis is that our new method will be quicker than the existing one.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• BMI 18-27

• Non-smoker

• No chronic cardiorespiratory or neuromuscular illness

• No intercurrent illness

Exclusion Criteria:

• Unable/unwilling to consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Oxygen
Experimental: Low flow Oxygen for 30 seconds then high flow for 3.5 minutes. Active comparator: High flow Oxygen for 4 minutes.

Locations

Country	Name	City	State
United Kingdom	Victoria Infirmary	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to end-tidal oxygen of 90%		5 minutes	No
Secondary	Level of discomfort as assessed by questionnaire		5 minutes	No