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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The FASTER stabilizing rod offers the distinct advantage of intubating through the laryngeal mask airway with a fiberoptic scope via the FASTER stabilizing rod. The device allows for the provider to insert the endotracheal tube (ETT) with visual confirmation using the fiberoptic scope into the trachea. The device then allows for the laryngeal mask airway to be removed while stabilizing the ETT to ensure the ETT does not get dislodged. 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 primary aims are to evaluate 1) the time to intubation and 2) the number of intubation attempts. The secondary aim is to note any complications from time to intubation to PACU discharge. These complications include: Hypoxemia (10% decrease from baseline for 45 seconds)1 Airway trauma (minor) Esophageal intubation Laryngospasm Bronchospasm Oro-pharyngeal bleeding Arrythmia Emesis Epistaxis Dental damage Post-operative sore throat Post-operative hoarseness Accidental extubation during removal of the LMA.

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.

Is the Stabilizing Rod for Intubation in Adults with Obesity generally safe for humans?

Fiberoptic intubation, which is similar to the Stabilizing Rod for Intubation, has been shown to be safe in various studies, with no reported complications in patients with difficult airways, including those with obesity. ^{1 2 3 4 5}

How is the Stabilizing Rod for Intubation in Adults with Obesity treatment different from other treatments?

The Stabilizing Rod for Intubation in Adults with Obesity is unique because it uses a fiberoptic-assisted technique, which helps visualize the airway more clearly, making it easier to intubate patients with obesity who often have difficult airways. This approach is different from traditional intubation methods that may not provide the same level of visibility and precision. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Fiberoptic Assisted Endotracheal Rod Intubation for adults with obesity?

Research shows that using fiberoptic intubation, especially when patients are awake, helps manage difficult airways in obese patients. Combining fiberoptic tools with other techniques, like video laryngoscopes, can improve the success rate of intubation in challenging cases. ^{1 5 9 10 11}

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. Switzerland pubmed.ncbi.nlm.nih.gov

Awake Nasal Fiberoptic Intubation in Lateral Position for Severely Obese Patients with Anticipated Difficult Airway: A Randomized Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Facilitation of fiberoptic nasotracheal intubation in a morbidly obese patient by simultaneous use of nasal CPAP. [2019]

3. Japan pubmed.ncbi.nlm.nih.gov

[Awake fiberoptic intubation with Parker Flex-Tip tracheal tube in a patient with obesity, goiter, and laryngo-tracheal shift]. [2010]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized controlled study on the visual grading of the glottis and the hemodynamics response to laryngoscopy when using I-View and MacGrath Mac videolaryngoscopes in super obese patients. [2021]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Successful airway management with combined use of McGrath® MAC video laryngoscope and fiberoptic bronchoscope in a severe obese patient with huge goiter -a case report. [2019]

6. Poland pubmed.ncbi.nlm.nih.gov

[A comparison of the optical AirTraq and the standard Macintosh laryngoscope for endotracheal intubation in obese patients]. [2014]

7. Spain pubmed.ncbi.nlm.nih.gov

[Our experience in fiberoptic intubation in anesthesia]. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Fiberoptic intubation in the emergency department. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Superior Laryngeal Nerve Block Facilitates Anesthesia Management in Bariatric Surgery. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The impact of obesity on the outcome of emergency intubation in trauma patients. [2008]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Anesthesia in obese patients]. [2006]