A Novel Method of Preoxygenation Using a Bain Circuit

NCT ID: NCT00958178

Last Updated: 2009-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

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

T method of preoxygenation

Tidal breathing of 100% oxygen through a well fitting facemask, for 4 minutes.

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type DRUG

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

Interventions

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Oxygen

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI 18-27
* Non-smoker
* No chronic cardiorespiratory or neuromuscular illness
* No intercurrent illness

Exclusion Criteria

* Unable/unwilling to consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Health Service, United Kingdom

OTHER_GOV

Sponsor Role lead

Responsible Party

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National Health Service

Principal Investigators

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John Glen, MBChB

Role: PRINCIPAL_INVESTIGATOR

UK National Health Service

Locations

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Victoria Infirmary

Glasgow, Glasgow, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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John Glen, MBChB; BSc

Role: CONTACT

+44(0)1414231465

Richard Price, MBChB

Role: CONTACT

+44(0)7872957716

Facility Contacts

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John Glen, MBChB; BSc

Role: primary

+44(0)1414231465

Other Identifiers

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08/S071038

Identifier Type: -

Identifier Source: org_study_id

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