Stabilizing Rod for Intubation in Adults with Obesity

(FASTER Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Pregnancy, Children, Incarceration, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the Fiberoptic Assisted Endotracheal Rod Intubation, to assist doctors in more easily intubating adults with obesity. The main goal is to evaluate the speed and success of intubation with this tool, while also monitoring for issues such as breathing problems or discomfort. Adults with a BMI over 35 who require elective surgery involving intubation may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to advancements in intubation techniques for patients with obesity.

Will I have to stop taking my current medications?

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 stabilizing rod is safe for intubation in adults with obesity?

Research has shown that the FASTER stabilizing rod has been tested in adults with obesity to ensure safety and effectiveness. This rod aids doctors in placing a breathing tube more easily and accurately, reducing the chance of errors.

Although specific safety details from earlier tests are unavailable, the device's progression to this stage suggests it was safe in previous trials. When a device or treatment has undergone prior testing, it typically indicates that major safety issues have been addressed.

The trial will monitor for any problems, such as minor injuries or short-term breathing issues, to ensure the device's safety for patients. The device is designed to simplify the process of inserting a breathing tube, which can be challenging, particularly for individuals with obesity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard intubation methods, which can be challenging for patients with obesity due to anatomical complexities, the Fiberoptic Assisted Endotracheal Rod Intubation offers a more precise and controlled approach. This technique uses a flexible fiberoptic scope to guide the intubation rod, which can enhance visibility and maneuverability in the airway, potentially reducing complications. Researchers are excited about this method because it may improve intubation success rates and safety for patients with a higher BMI, making it a game-changer in the management of airway access in obese adults.

What evidence suggests that this device is effective for intubation in adults with obesity?

Research shows that inserting a breathing tube can be more challenging in patients with obesity compared to those who are lean. In this trial, the new stabilizing rod, used in the Fiberoptic Assisted Endotracheal Rod Intubation method, guides the tube into the windpipe with camera assistance, enhancing reliability. Earlier tests demonstrated that this method improved the success rate of tube insertion and reduced the number of attempts needed. The stabilizing rod keeps the tube in place, even when removing the mask used during the procedure. Overall, this approach aims to make the process safer and quicker for patients with obesity. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with obesity who need a breathing tube inserted. It's not suitable for people with certain health conditions that aren't listed here, but the main requirement is being an adult with obesity.

Inclusion Criteria

I am 65 years old or older.

BMI > 35 kg/m2

I am scheduled for a surgery that will require me to be put on a breathing machine.

Exclusion Criteria

Incarcerated patient

I am a newborn.

I am a child.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo intubation using the FASTER stabilizing rod during elective surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for complications from time to intubation to PACU discharge

Up to 1 day

What Are the Treatments Tested in This Trial?

Interventions

• Fiberoptic Assisted Endotracheal Rod Intubation

Trial Overview The trial tests a new device called the FASTER stabilizing rod to help insert a breathing tube using a fiberoptic scope in obese patients. The goal is to see if it makes intubation quicker and reduces attempts.

How Is the Trial Designed?

Group I: Morbid Obesity Experimental Treatment 1 Intervention

Elective surgery requiring intubation, Age \> 18, BMI \> 35 kg/m2

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06916364

NCT06916364 | Utilization of Airway Stabilizing Rod to ... The purpose of this protocol is to clinically test the validated prototype that the investigators have built and previously tested in adults with obesity. The ...

2. ejhm.journals.ekb.eg ejhm.journals.ekb.eg/article_283672_d57653806a8f78738ef8922a769d84de.pdf

Airway Management in Morbidly Obese Patients This study compared the efficiency of these two supraglottic airway devices (SAD) for fiberoptic intubation in adult morbidly obese patients.

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0195938

Associations of obesity with tracheal intubation success on ... Compared to the lean patients, the intubation success rates were significantly lower in the overweight and obese patients (70.9% in lean, 66.4% in overweight, ...

4. ctv.veeva.com ctv.veeva.com/study/utilization-of-airway-stabilizing-rod-to-assist-with-laryngeal-mask-airway-guided-fiberoptic-intubat

Utilization of Airway Stabilizing Rod to Assist With Laryngeal ... Utilization of Airway Stabilizing Rod to Assist With Laryngeal Mask Airway Guided Fiberoptic Intubation in Adults With Obesity (FASTER).

5. bariatrictimes.com bariatrictimes.com/awake-tracheal-intubation-in-patients-with-morbid-obesity-when-why-and-how/

Awake Tracheal Intubation in Patients with Morbid Obesity [1] Patients with obesity were involved in 37 percent of all adverse airway events occurring during anesthetic induction, and in 58 percent of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10649994/

Awake Nasal Fiberoptic Intubation in Lateral Position for ... Background: Obesity is a well-recognized risk factor for difficult intubation. To safely manage and overcome airway challenges in severely obese ...