NCT00958178

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_4 healthy-volunteers

Timeline
Completed

Started Aug 2009

Typical duration for phase_4 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 13, 2009

Status Verified

August 1, 2009

Enrollment Period

10 months

First QC Date

August 12, 2009

Last Update Submit

August 12, 2009

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Time to end-tidal oxygen of 90%

    5 minutes

Secondary Outcomes (1)

  • Level of discomfort as assessed by questionnaire

    5 minutes

Study Arms (2)

Rebreathing method of preoxygenation

EXPERIMENTAL

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

T method of preoxygenation

ACTIVE COMPARATOR

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

Drug: Oxygen

Interventions

OxygenDRUG

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

Rebreathing method of preoxygenationT method of preoxygenation

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Unable/unwilling to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Infirmary

Glasgow, Glasgow, G42 9LF, United Kingdom

RECRUITING

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • John Glen, MBChB

    UK National Health Service

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Glen, MBChB; BSc

CONTACT

+44(0)1414231465johnglen@doctors.org.uk

Richard Price, MBChB

CONTACT

+44(0)7872957716rjp@doctors.org.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 13, 2009

Record last verified: 2009-08

Locations

GB(1)