Clinical trial NCT03138850: Improve Oxygenation and Capnographic Detection During Sedative EGD
Official title: Comparison of Techniques to Improve Oxygenation and Capnographic Detection During Sedative Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Airway Obstruction
Apnea, Obstructive
Keywords: intravenous sedation
esophagogastroduodenalscopy
upper airway
mandibular advancement device
high flow nasal cannula
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2017-05-03
Enrollment: 170
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Area under the curve of 95% oxygen desaturation (AUCdesat)
timeFrame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Secondary outcomes:
measure: Number of rescue interventions
timeFrame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
measure: Number of apnea episodes
timeFrame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
measure: Number of partial airway obstruction episodes
timeFrame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
measure: Number of total airway obstruction episodes
timeFrame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Wei-Nung Teng, MD
role: PRINCIPAL_INVESTIGATOR
References: