Improve Oxygenation and Capnographic Detection During Sedative EGD

Taipei Veterans General Hospital

Status: Completed

Conditions: Apnea, Obstructive; Upper Airway Obstruction

Treatments: Device: Olympus standard bite block; Device: YX mandibular advancement bite block; Device: Optiflow High flow nasal cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT03138850

2017-03-003B

Details and patient eligibility

About

The purpose of this study is to compare the effect of mandibular advancement bite block and high flow nasal cannula to standard bite block for oxygenation, capnographic measurement, prevention of hypoxemia, intervention events and adverse effects during endoscopic examinations.

Full description

During endoscopic examinations, especially during those performed via oral insertion of endoscopes, an oral bite is used to protect the examination instruments and patients. During sedated endoscopic examinations, the patients are under influence of anesthetics. Upper airway obstruction often occurred due to respiratory depression and airway collapse resulting in desaturation. Airway management with high percentage oxygen, jaw thrust, or insertion of nasal airways by trained anesthetic personnel is required during upper airway obstruction emergencies. Nasal airway is invasive and causes nasal bleeding, sinusitis and other problems. Jaw thrust and bag-mask ventilation requires training and is a burden to anesthetic personnel to perform. Oxygenation and capnography are important ventilatory monitors during sedative procedures. These are often influenced by open mouth breathing during upper gastrointestinal endoscopic examinations making oxygenation and capnographic measurements unreliable. In this study, we group the patients into A group using standard of care, B group using mandibular advancement oral bite and C group using high-flow nasal cannulas. After anesthetic induction, gastric endoscopy will be performed. Oxygenation, end-tidal carbon dioxide, and degree of upper airway obstruction will be evaluated and recorded. Differences between the groups will be evaluated.

Enrollment: 170 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients aged 20 to 80 years with ASA physical status I to II undergoing routine outpatient upper gastrointestinal endoscopy

Exclusion criteria

• Baseline oxygen saturation < 90%
• Known upper airway obstruction, difficult intubation history
• Unstable or lost of upper and lower incisors
• Known past oral or neck surgeries
• Anticipate exam time > 30 mins

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 3 patient groups

Olympus standard bite block

Experimental group

Description:

Standard of care using standard bite block and nasal cannula

Treatment:

Device: Olympus standard bite block

YX Mandibular advancement bite block

Experimental group

Description:

Mandibular advancement bite block group

Treatment:

Device: YX mandibular advancement bite block

Optiflow High flow nasal cannula

Experimental group

Description:

High flow nasal cannula group

Treatment:

Device: Optiflow High flow nasal cannula