A Novel Method of Preoxygenation Using a Bain Circuit
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: Oxygen |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Novel Method of Preoxygenation Using Partial Rebreathing Via a Coaxial Mapleson D Breathing System (Bain Circuit) |
- Time to end-tidal oxygen of 90% [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
- Level of discomfort as assessed by questionnaire [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rebreathing method of preoxygenation
Subjects will breathe Oxygen through a close fitting mask, but the flow will be low so that they rebreathe some of their expired air. After 30 seconds, the flow will be turned up so that they will breathe 100% Oxygen.
|
Drug: Oxygen
Experimental: Low flow Oxygen for 30 seconds then high flow for 3.5 minutes. Active comparator: High flow Oxygen for 4 minutes.
|
|
Active Comparator: T method of preoxygenation
Tidal breathing of 100% oxygen through a well fitting facemask, for 4 minutes.
|
Drug: Oxygen
Experimental: Low flow Oxygen for 30 seconds then high flow for 3.5 minutes. Active comparator: High flow Oxygen for 4 minutes.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- BMI 18-27
- Non-smoker
- No chronic cardiorespiratory or neuromuscular illness
- No intercurrent illness
Exclusion Criteria:
- Unable/unwilling to consent
Contacts and Locations| Contact: John Glen, MBChB; BSc | +44(0)1414231465 | johnglen@doctors.org.uk |
| Contact: Richard Price, MBChB | +44(0)7872957716 | rjp@doctors.org.uk |
| United Kingdom | |
| Victoria Infirmary | Recruiting |
| Glasgow, United Kingdom, G42 9LF | |
| Contact: John Glen, MBChB; BSc +44(0)1414231465 johnglen@doctors.org.uk | |
| Principal Investigator: John Glen, MBChB | |
| Principal Investigator: | John Glen, MBChB | UK National Health Service |
More Information
No publications provided
| Responsible Party: | John Glen, National Health Service |
| ClinicalTrials.gov Identifier: | NCT00958178 History of Changes |
| Other Study ID Numbers: | 08/S071038 |
| Study First Received: | August 12, 2009 |
| Last Updated: | August 12, 2009 |
| Health Authority: | United Kingdom: National Health Service |
ClinicalTrials.gov processed this record on May 21, 2013