Oxygenating Bite Block for Endoscopy

(OBB Trial)

Overseen By Robert Wong, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Airway risk, Missing teeth, TMJ, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new bite block for use during endoscopy procedures. The bite block keeps the mouth open and allows doctors to provide oxygen and measure breathing more easily. The trial involves adults with obesity who are scheduled for an endoscopy and can consent to participate. Participants will use this new bite block during their procedure and then provide feedback on comfort and sedation levels.

As an unphased trial, this study allows participants to contribute to advancements in endoscopy care and enhance patient comfort.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this bite block is safe for endoscopic procedures?

Research shows that the Oxygenating Bite Block (OBB) aids breathing during endoscopy. Studies have found that improved oxygen flow can reduce the risk of low oxygen levels, a common issue during these procedures.

Although specific safety data for the OBB is not yet available, similar devices used in endoscopies have reduced breathing problems. For example, one study found that a similar device decreased the risk of significant oxygen level drops from 22% to 6% in some patients. This suggests that the OBB might effectively maintain stable oxygen levels.

No specific reports of negative effects from using the OBB exist, but the goal is to make endoscopy safer and more comfortable. Prospective trial participants may find this information reassuring regarding the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Oxygenating Bite Block (OBB) because it offers a new way to enhance patient comfort and safety during endoscopy procedures. Unlike the standard bite blocks that simply protect the mouth, the OBB also provides oxygen, which could improve patient sedation levels and overall experience. This dual function aims to reduce discomfort and potentially enhance the effectiveness of the procedure, making it a promising advancement in endoscopic techniques.

What evidence suggests that this oxygenating bite block is effective for endoscopy?

Studies have shown that a special mouthpiece called an oxygenating bite block can safely provide high levels of extra oxygen during endoscopic procedures. Participants in this trial will use this device, which is designed to reduce the risk of hypoxia, a condition of low oxygen levels that can occur during these procedures. Research also suggests that this bite block helps monitor carbon dioxide levels, crucial for patient safety. However, no specific studies have yet detailed its effectiveness or possible side effects. The technology appears promising and aims to enhance comfort and safety during endoscopy. ^{1 2 3 4 6}

Who Is on the Research Team?

Robert Wong, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for obese adults classified as ASA class I - III, from various racial and ethnic backgrounds, who are scheduled for an upper endoscopy. Participants must be able to understand and sign a consent form.

Inclusion Criteria

I am an adult with obesity and have an ASA class between I and III.

I am willing and able to sign a consent form.

I come from a diverse racial or ethnic background.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

Treatment

Participants undergo an endoscopy procedure using the Oxygenating Bite Block

1 day

1 visit (in-person)

Follow-up

Participants complete a questionnaire to assess satisfaction and tolerability of the device

Up to 5 minutes

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Oxygenating Bite Block

Trial Overview The study is testing a new bite block designed to hold the endoscope in place while allowing oxygen delivery and carbon dioxide measurement during the procedure.

How Is the Trial Designed?

Group I: Oxygenating Bite Block (OBB) Experimental Treatment 1 Intervention

During the endoscopy procedure, the oxygenating bite block will be placed in the mouth instead of the standard and customary bite block. After the endoscopy procedure, the participant will be asked to complete a short questionnaire to find out their satisfaction with the level of sedation during the procedure, the tolerability of the device, and any discomfort.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12465271/

Clinical efficacy of COMBO endoscopy of oropharyngeal ... Here, we plan to apply COMBO (Capnography Monitoring Bite Block Oxygenation) endoscopy of the oropharyngeal airway, a novel airway ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8039741/

Recent Developments in Devices Used for Gastrointestinal ... No studies have documented its effectiveness and possible adverse effects. The OxyShieldTM (Fig. 4) is another endoscopic bite block with similar capabilities [ ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1542356525005361

Nasal Continuous Positive Airway Pressure to Reduce ... The primary outcome was the incidence of oxygen desaturation (SpO2 <90%) during endoscopy. Secondary outcomes included the need for airway ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06081647

Study Details | NCT06081647 | The Efficacy and Safety of ... The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia ...

5. wjgnet.com wjgnet.com/1948-5190/full/v14/i12/777.htm

High-flow oxygen via oxygenating mouthguard in short ... Higher flows of supplemental oxygen can safely be delivered via an oxygenating mou thguard routinely used during upper GI endoscopic procedures.

6. medpagetoday.com medpagetoday.com/meetingcoverage/asa/117974

Combo Airway Device Helps Safety of GI Endoscopy With ... Even better, in a separate, smaller trial limited to obese patients only, hypoxemia was significantly down with the device (6% vs 22%, P<0.001), ...