Improve Oxygenation and Capnographic Detection During Sedative EGD

NCT ID: NCT03138850

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-03
• Study Completion Date: 2017-06-22

Brief Summary

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.

Detailed 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.

Conditions

Upper Airway Obstruction; Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Olympus standard bite block

Standard of care using standard bite block and nasal cannula

Group Type: EXPERIMENTAL

Olympus standard bite block

Intervention Type: DEVICE

Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and nasal cannula with oxygen 5L/min

YX Mandibular advancement bite block

Mandibular advancement bite block group

Group Type: EXPERIMENTAL

YX mandibular advancement bite block

Intervention Type: DEVICE

Intravenous sedative upper gastrointestinal endoscopy performed under mandibular advancement bite block for endoscopy (Yong Xu breathing mouth piece, Yong Xu) and oxygen connected to mouth piece 5L/min

Optiflow High flow nasal cannula

High flow nasal cannula group

Group Type: EXPERIMENTAL

Optiflow High flow nasal cannula

Intervention Type: DEVICE

Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and high flow nasal cannula

Interventions

Olympus standard bite block

Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and nasal cannula with oxygen 5L/min

Intervention Type: DEVICE

YX mandibular advancement bite block

Intravenous sedative upper gastrointestinal endoscopy performed under mandibular advancement bite block for endoscopy (Yong Xu breathing mouth piece, Yong Xu) and oxygen connected to mouth piece 5L/min

Intervention Type: DEVICE

Optiflow High flow nasal cannula

Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and high flow nasal cannula

Intervention Type: DEVICE

Other Intervention Names

A; B; C

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei-Nung Teng, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2017-03-003B

Identifier Type: -

Identifier Source: org_study_id