Improve Oxygenation and Capnographic Detection During Sedative EGD

NCT03138850 | Completed DMC

• 1 other identifier: 2017-03-003B
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Airway Obstruction; Apnea, Obstructive

Keywords

intravenous sedation; esophagogastroduodenalscopy; upper airway; mandibular advancement device; high flow nasal cannula

Outcome Measures

Primary Outcomes (1)

• Area under the curve of 95% oxygen desaturation (AUCdesat)

  AUCdesat is defined as the integrated area under oxygen saturation (SPO2) for a selected cut point per 30 seconds, which better reflects the duration and severity of hypoxemia than the lowest saturation

  From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour

Secondary Outcomes (4)

• Number of rescue interventions

  From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour

• Number of apnea episodes

  From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour

• Number of partial airway obstruction episodes

  From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour

• Number of total airway obstruction episodes

  From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour

Study Arms (3)

Olympus standard bite block

EXPERIMENTAL

Standard of care using standard bite block and nasal cannula

Device: Olympus standard bite block

YX Mandibular advancement bite block

EXPERIMENTAL

Mandibular advancement bite block group

Device: YX mandibular advancement bite block

Optiflow High flow nasal cannula

EXPERIMENTAL

High flow nasal cannula group

Device: Optiflow High flow nasal cannula

Interventions

Olympus standard bite block DEVICE

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

Also known as: A

Olympus standard bite block

YX mandibular advancement bite block 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

Also known as: B

YX Mandibular advancement bite block

Optiflow High flow nasal cannula DEVICE

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

Also known as: C

Optiflow High flow nasal cannula

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Airway Obstruction; Sleep Apnea, Obstructive

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Sleep Apnea Syndromes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Wei-Nung Teng, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: May 3, 2017
• Study Start: May 3, 2017
• Primary Completion: June 22, 2017
• Study Completion: June 22, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-05

Locations

TW (1)