Airway ObstructionNCT02964299

Mandibular Advancement Bite Block Efficacy Observational Study

An observational study of Airway Obstruction, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to compare the effect of mandibular advancement bite block to standard bite block for 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: Airway Obstruction
What is being tested?: Mandibular advancement bite block
Type of treatment: Medical device
How many people: 120 participants
Where: 1 siteTaiwan
Study dates: Jul 2016to Oct 2016
Phase: Observational
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

Study population: ASA class I or II patients admitted for routine upper gastrointestinal endoscopy

Who may be able to join

American Society of Anesthesiologist class I or II
Patients undergoing routine upper gastrointestinal endoscopy under sedation

Who cannot join

Baseline oxygen saturation < 90%
Known difficult airway
Oral or facial surgery history
BMI > 35
patients with gastroparesis or gastrointestinal bleeding
anticipated exam time > 30 minutes

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, Taiwan, 112

Other trials in Taiwan

About this study

Read the detailed description

During endoscopic examinations, especially upper gastrointestinal, bile duct, or bronchoscopic examinations, the endoscope need to be placed through the mouth. A bite block is used to protect vulnerable endoscope and protect patient's teeth. During sedative endoscopic exams, respiratory depression, apnea or upper airway obstruction will occur under the influence of the sedative medications. Serious adverse events may occur such as hypoxemia. A nasal airway, Larson's maneuver, jaw thrust or chin lift may be needed to open airways.

Mandibular advancement devices has been widely used in treating obstructive sleep apnea. A modified bite block that provides mandibular advancement could provide entry inlet of endoscope as well as provide mandibular advancement to provide patent airway during sedative endoscopy. In this study, we group the patients into test group using mandibular advancement bite block and a control group using standard bite block. After anesthetic induction, gastric endoscopy was performed. Degree of upper airway obstruction will be evaluated and recorded. Differences between the two groups will be evaluated.

Conditions: Airway Obstruction
Being tested: Mandibular advancement bite block
Keywords: Gastrointestinal endoscopy, Moderate sedation, Airway management
Medical subject headings: Airway Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mandibular advancement bite blockDevice
Mandibular advancement bite block that provides mandibular advancement by 3 mm, 6 mm, or 9 mm from neutral position

Study groups in NCT02964299
Study group	Role	What they receive
Standard		Standard bite block
Mandibular advancement bite block		Mandibular advancement by 3 mm, 6 mm or 9 mm from neutral position Receives: Device: Mandibular advancement bite block

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under curve of 95% oxygen desaturation
From start of sedation drug administration to end of endoscopic examination with the endoscope withdrawal from patient's mouth, peripheral oxygen saturation recorded. Area under curve of 95% oxygen desaturation is calculated by (95-saturation) x time.
Measured: up to 30 minutes

Secondary outcomes (2)

number of rescue interventions: chin lift, jaw thrust, insertion of nasal airway or mask-bag ventilation
From start of sedation drug administration to end of endoscopic examination with the endoscope withdrawal from patient's mouth, number of events such as chin lift, jaw thrust, insertion of nasal airway, or mask-bag ventilation recorded.
Measured: up to 30 minutes
Adverse events: partial or complete airway obstruction, or apnea
From start of sedation drug administration to end of endoscopic examination with the endoscope withdrawal from patient's mouth, number of events such as snoring, stridor, apnea, airway obstruction or loss of end tidal carbon dioxide waveform recorded.
Measured: up to 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016Oct 2016

First posted16 Nov 2016 (estimated)
Study startJul 2016
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02964299
Sponsor's protocol ID: 2016-04-003C
Status last verified: Nov 2016
First submitted: 26 Oct 2016
Last updated: 16 Nov 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
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Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
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A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Enrolling by invitationObservational study
Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)
Neoplasms, Airway Obstruction Upper
RecruitingObservational study
Canadian Consortium on Airway Mucus Occlusions in Asthma, COPD and Chronic Cough
Asthma, Chronic Obstructive Pulmonary Disease (COPD)

All Airway Obstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mandibular Advancement Bite Block Efficacy Observational Study
ClinicalTrials.gov ID: NCT02964299
Acronym / sponsor ID: 2016-04-003C
Conditions: Airway Obstruction
Keywords: Gastrointestinal endoscopy, Moderate sedation, Airway management
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Taipei Veterans General Hospital, TaiwanOther government
Study start: Jul 2016
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 16 Nov 2016 (estimated)
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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Standard	–	–Standard bite block
Mandibular advancement bite block	–	Device: Mandibular advancement bite blockMandibular advancement by 3 mm, 6 mm or 9 mm from neutral position

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: ASA class I or II patients admitted for routine upper gastrointestinal endoscopy

Key inclusion criteria (2 listed)

American Society of Anesthesiologist class I or II
Patients undergoing routine upper gastrointestinal endoscopy under sedation

Key exclusion criteria (6 listed)

Baseline oxygen saturation < 90%
Known difficult airway
Oral or facial surgery history
BMI > 35
patients with gastroparesis or gastrointestinal bleeding

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
Mandibular advancement bite blockMandibular advancement bite block that provides mandibular advancement by 3 mm, 6 mm, or 9 mm from neutral position	Device	Mandibular advancement bite block

Primary outcome

Area under curve of 95% oxygen desaturation
Time frame: up to 30 minutes
From start of sedation drug administration to end of endoscopic examination with the endoscope withdrawal from patient's mouth, peripheral oxygen saturation recorded. Area under curve of 95% oxygen desaturation is calculated by (95-saturation) x time.

2 secondary outcomes

number of rescue interventions: chin lift, jaw thrust, insertion of nasal airway or mask-bag ventilation
Time frame: up to 30 minutes
Adverse events: partial or complete airway obstruction, or apnea
Time frame: up to 30 minutes

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 16 Nov 2016.
Individual participant dataSharing planned: Undecided

Related trials for Airway Obstruction

Not yet recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal 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
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Enrolling by invitationObservational study
Difficult Airway Management in Oncology: An International Delphi Consensus Study (DAMO)
Neoplasms, Airway Obstruction Upper
RecruitingObservational study
Canadian Consortium on Airway Mucus Occlusions in Asthma, COPD and Chronic Cough
Asthma, Chronic Obstructive Pulmonary Disease (COPD)

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?

An observational study of Airway Obstruction, 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 2 inclusion and 6 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 16 Nov 2016. 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 curve of 95% oxygen desaturation (time frame: up to 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02964299.

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 16 Nov 2016.