Upper Airway ObstructionNCT03138850
Improve Oxygenation and Capnographic Detection During Sedative EGD
A study testing Olympus standard bite block, YX mandibular advancement bite block and Optiflow High flow nasal cannula in people with Upper Airway Obstruction and Apnea, Obstructive, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Upper Airway Obstruction, Apnea, Obstructive
- What is being tested?
- Olympus standard bite block, YX mandibular advancement bite block and Optiflow High flow nasal cannula
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 May 2017to 22 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 20 to 80 years with ASA physical status I to II undergoing routine outpatient upper gastrointestinal endoscopy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, 112
About this study
Official title: Comparison of Techniques to Improve Oxygenation and Capnographic Detection During Sedative Gastrointestinal Endoscopy
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.
Read the 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
- Being tested
- Olympus standard bite block, YX mandibular advancement bite block, Optiflow High flow nasal cannula
- Keywords
- intravenous sedation, esophagogastroduodenalscopy, upper airway, mandibular advancement device, high flow nasal cannula
- Medical subject headings
- Airway Obstruction, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympus standard bite blockDevice
Also called A
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 blockDevice
Also called B
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 cannulaDevice
Also called C
Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and high flow nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| Olympus standard bite block | Experimental | Standard of care using standard bite block and nasal cannula Receives: Device: Olympus standard bite block |
| YX Mandibular advancement bite block | Experimental | Mandibular advancement bite block group Receives: Device: YX mandibular advancement bite block |
| Optiflow High flow nasal cannula | Experimental | High flow nasal cannula group Receives: Device: Optiflow High flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Number of apnea episodes
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.
Measured: 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
Number of partial airway obstruction episodes, which are number of times grunting or snoring with positive ETCO2 measurement greater than 30 secs occurs.
Measured: 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
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.
Measured: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start3 May 2017
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Airway ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wei-Nung Teng, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138850
- Sponsor's protocol ID
- 2017-03-003B
- Status last verified
- May 2017
- First submitted
- 18 Apr 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Techniques to Improve Oxygenation and Capnographic Detection During Sedative Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT03138850
- Acronym / sponsor ID
- 2017-03-003B
- Conditions
- Upper Airway Obstruction, Apnea, Obstructive
- Keywords
- intravenous sedation, esophagogastroduodenalscopy, upper airway, mandibular advancement device, high flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 3 May 2017 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olympus standard bite block | Experimental | Device: Olympus standard bite blockStandard of care using standard bite block and nasal cannula |
| YX Mandibular advancement bite block | Experimental | Device: YX mandibular advancement bite blockMandibular advancement bite block group |
| Optiflow High flow nasal cannula | Experimental | Device: Optiflow High flow nasal cannulaHigh flow nasal cannula group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients aged 20 to 80 years with ASA physical status I to II undergoing routine outpatient upper gastrointestinal endoscopy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olympus standard bite blockAlso: AIntravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and nasal cannula with oxygen 5L/min | Device | Olympus standard bite block |
| YX mandibular advancement bite blockAlso: BIntravenous 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 | Device | YX Mandibular advancement bite block |
| Optiflow High flow nasal cannulaAlso: CIntravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and high flow nasal cannula | Device | Optiflow High flow nasal cannula |
Primary outcome
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
4 secondary outcomes
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 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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Upper Airway Obstruction
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
Enrolling by invitationObservational study
Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)
Neoplasms, Airway Obstruction Upper
Not yet recruiting
Asthma Lung Sounds With Wearable Stethoscope
Asthma, Pediatric Asthma
Recruiting
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
Obstructive Sleep Apnea, Hypertonia, Muscle
Recruiting
Thyroid Cartilage Plane VS Superior Laryngeal Nerve Space Block in Awake Tracheal Intubation
Superior Laryngeal Nerve Block
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Nung Teng, MD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olympus standard bite block, YX mandibular advancement bite block and Optiflow High flow nasal cannula in people with Upper Airway Obstruction and Apnea, Obstructive, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.