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

Trawax

Status and phase

Completed

Phase 2

Conditions

Hypercapnia

Hypoxia

Treatments

Device: CO2 sample line

Device: Standard endoscopic bite block

Device: TwinGuard

Device: Standard nasal cannula

Study type

Interventional

Funder types

Other

Identifiers

NCT00619606

CDD05/C05

TGA CTN 089/2006

Details and patient eligibility

About

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.

Full 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)

Enrollment

150 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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