Utilization of Airway Stabilizing Rod (FASTER)

Utilization of Airway Stabilizing Rod to Assist With LMA Guided Fiberoptic Intubation in Children

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).

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia
• Intervention / Treatment: Device: Time to Intubation using FASTER device

Detailed Description

The objective is to study this device in patients with difficult airway to assess the success rate and time to intubation for placing an endotracheal tube using this device.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hosppital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Time to intubation using FASTER device; 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; Time from fiberoptic placement onto airway to documentation of end-tidal carbon dioxide waveform through the endotracheal tube.; Other Names: FASTER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Arvind Chandrakantan, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Actual): May 17, 2024
• Study Completion (Actual): May 17, 2024

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H50120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This pilot data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes