Utilization of Airway Stabilizing Rod

NCT05899868 | Completed DMC FDA Device

• 1 other identifier: H50120
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The pediatric airway is known to be more challenging than the adult airway when performing endotracheal intubation. When a patient cannot be ventilated and/or intubated, the guidelines for airway management dictate that a laryngeal mask airway (LMA) be used as a rescue device to oxygenate and ventilate the patient. While an excellent device the LMA is seen as temporary and ultimately needs to be replaced by an endotracheal tube (ETT).

Conditions

Airway Complication of Anesthesia

Outcome Measures

Primary Outcomes (2)

• Overall time in the airway

  Time from fiberoptic placement onto airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.

  5 minutes

• Total time to intubation

  Time from movement of the device to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.

  3 minutes

Study Arms (1)

Time to intubation using FASTER device

OTHER

Time from fiberoptic placement into airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.

Device: Time to Intubation using FASTER device

Interventions

Time to Intubation using FASTER device DEVICE

Time from fiberoptic placement onto airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.

Also known as: FASTER

Time to intubation using FASTER device

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 5-18 years
• Requiring intubation
• Known difficult airway
• LMA placement possible

You may not qualify if:

• Known normal airway
• Procedure not requiring endotracheal intubation
• Parental refusal
• Patient dissent

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hosppital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Adler AC, Duong K, Chandrakantan A. Fiberoptic-Assisted Endotracheal Rod for Endotracheal Intubation Through a Supraglottic Airway in Patients with Difficult Intubation: A Clinical Device Study. Anesth Analg. 2025 Apr 1;140(4):986-989. doi: 10.1213/ANE.0000000000007268. Epub 2024 Nov 21. No abstract available.

  PMID: 39774053 DERIVED

Study Officials

• Arvind Chandrakantan, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

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: Associate Professor of Anesthesiology

Model Details: Testing of device for success during endotracheal intubation

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 12, 2023
• Study Start: October 12, 2023
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)