To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure

A Randomised, Parallel, Open Label Study to Determine the Efficacy of a New Oral-Nasal Oxygenating Device (TwinGuard) Compared to Standard Bite Block Plus Nasal Cannulae

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00619606

Enrollment

150

Registered

2008-02-21

Start date

2006-11-30

Completion date

2007-03-31

Last updated

2008-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia, Hypercapnia

Keywords

prevention of hypoxia, prevention of hypercapnia

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.

Detailed description

Hypoxia is common during endoscopy. Following sedation induction, oxygen saturation falls moderately in most patients, whilst some drop to unacceptable levels. To monitor such changes endoscopic practices routinely use oximeters and capnography. TwinGuard is an all-in-one device which incorporates a bite block with the functionality of nasal cannula as well as monitoring expired air (carbon dioxide)

Interventions

DEVICECO2 sample line

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

DEVICETwinGuard

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.

DEVICEStandard endoscopic bite block

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

DEVICEStandard nasal cannula

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026