NCT06916364

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

April 21, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

March 25, 2025

Last Update Submit

May 13, 2025

Conditions

AdultObesity, Morbid

Keywords

fasterLaryngeal mask airway guided intubationFiberoptic IntubationAirway Stabilizing Rod

Outcome Measures

Primary Outcomes (2)

  • Time to Intubation

    Time of disconnecting the circuit from supraglottic airway (SGA) to the presence of end tidal carbon dioxide (ETCO2) for intubation.

    3 minutes

  • Number of Intubation Attempts

    Defined as failure to capture end tidal carbon dioxide after completion of intubation.

    5 minutes

Secondary Outcomes (1)

  • Complications

    Up to 1 day

Study Arms (1)

Morbid Obesity

EXPERIMENTAL

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

Device: Fiberoptic Assisted Endotracheal Rod Intubation

Interventions

Fiberoptic Assisted Endotracheal Rod IntubationDEVICE

Fiberoptic-Assisted Endotracheal Rod for Endotracheal Intubation Through a Supraglottic Airway

Also known as: FASTER
Morbid Obesity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (18-64 yrs),
  • Geriatric (65+ yrs)
  • BMI \> 35 kg/m2
  • elective surgery requiring intubation

You may not qualify if:

  • pregnant woman
  • neonates
  • children
  • incarcerated patient
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • Kovatsis PG. Continuous ventilation during flexible fiberscopic-assisted intubation via supraglottic airways. Paediatr Anaesth. 2016 Apr;26(4):457-8. doi: 10.1111/pan.12863. No abstract available.

    PMID: 26956516BACKGROUND

  • van Zundert TC, Wong DT, van Zundert AA. The LMA-Supreme as an intubation conduit in patients with known difficult airways: a prospective evaluation study. Acta Anaesthesiol Scand. 2013 Jan;57(1):77-81. doi: 10.1111/aas.12011. Epub 2012 Nov 21.

    PMID: 23167262BACKGROUND

  • Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.

    PMID: 34762729BACKGROUND

  • Joffe AM, Aziz MF, Posner KL, Duggan LV, Mincer SL, Domino KB. Management of Difficult Tracheal Intubation: A Closed Claims Analysis. Anesthesiology. 2019 Oct;131(4):818-829. doi: 10.1097/ALN.0000000000002815.

    PMID: 31584884BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 8, 2025

Study Start

April 21, 2025

Primary Completion

July 31, 2025

Study Completion

September 1, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Locations

US(1)