NCT00619606

Brief Summary

A comparative study which compares the end-tidal carbon dioxide and oxygen saturation levels of patients during endoscopy which have used either the new oral-nasal oxygenating device (TwinGuard), or a standard bite block plus nasal cannulae using an equivalent flow rate of oxygen.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2

Status
completed

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

November 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
Last Updated

February 21, 2008

Status Verified

February 1, 2008

Enrollment Period

4 months

First QC Date

January 31, 2008

Last Update Submit

February 20, 2008

Conditions

HypoxiaHypercapnia

Keywords

prevention of hypoxiaprevention of hypercapnia

Interventions

TwinGuardDEVICE

A system consisting of an endoscopic bite block that fits together with a nasal cannula. After gastroscopy, the bite block is discarded leaving the patient receiving oxygen in recovery.An optional carbon dioxide sampling device fits with the TwinGuard in endoscopy to monitor expired air.

Standard endoscopic bite blockDEVICE

Placed in the mouth during gastroscopy to protect the endoscope and the patient's teeth

Standard nasal cannulaDEVICE

Delivers oxygen to the nose. Tubing runs from the nose around the back of the ears and under the chin which then runs to an oxygen source.

CO2 sample lineDEVICE

Samples expired air from a patients nose. Tubing is connected to a capnograph.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provided written fully informed consent as per protocol
  • No clinical evidence of significant respiratory conditions
  • Fasted for 6 hours prior to enrolment as per standard clinical practice for panendoscopy

You may not qualify if:

  • Patients suffering from cardio respiratory disease, moderate to severe asthma, lung and heart disease
  • Patients who have a history of drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypoxiaHypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas J Borody

    Centre for Digestive Diseases, Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 21, 2008

Study Start

November 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

February 21, 2008

Record last verified: 2008-02