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Improve Oxygenation and Capnographic Detection During Sedative EGD

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ClinicalTrials.gov Identifier: NCT03138850
Recruitment Status : Completed
First Posted : May 3, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Upper Airway Obstruction Apnea, Obstructive Device: Olympus standard bite block Device: YX mandibular advancement bite block Device: Optiflow High flow nasal cannula Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Techniques to Improve Oxygenation and Capnographic Detection During Sedative Gastrointestinal Endoscopy
Actual Study Start Date : May 3, 2017
Actual Primary Completion Date : June 22, 2017
Actual Study Completion Date : June 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

Arm Intervention/treatment
Experimental: Olympus standard bite block
Standard of care using standard bite block and nasal cannula
Device: 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
Other Name: A

Experimental: YX Mandibular advancement bite block
Mandibular advancement bite block group
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
Other Name: B

Experimental: Optiflow High flow nasal cannula
High flow nasal cannula group
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
Other Name: C




Primary Outcome Measures :
  1. Area under the curve of 95% oxygen desaturation (AUCdesat) [ Time Frame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour ]
    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


Secondary Outcome Measures :
  1. Number of rescue interventions [ Time Frame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour ]
    Number of rescue interventions counted if any of the following procedures are performed, such as sustained chin lift or jaw thrust, insertion of an oral or nasal airway or bag-mask ventilation.

  2. Number of apnea episodes [ Time Frame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour ]
    Number of apnea episodes, which are number of times which the patient lack respiratory activity and loss of ETCO2 detection greater for 30 seconds occurs.

  3. Number of partial airway obstruction episodes [ Time Frame: 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, which are number of times grunting or snoring with positive ETCO2 measurement greater than 30 secs occurs.

  4. Number of total airway obstruction episodes [ Time Frame: 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, which are number of times loss of ETCO2 detection while in presence of respiratory activity greater than 30 secs occurs.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138850


Locations
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Taiwan
Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Wei-Nung Teng, MD Taipei Veterans General Hospital, Taiwan
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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03138850    
Other Study ID Numbers: 2017-03-003B
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
intravenous sedation
esophagogastroduodenalscopy
upper airway
mandibular advancement device
high flow nasal cannula
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Airway Obstruction
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Insufficiency