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Utilization of Airway Stabilizing Rod

NCT ID: NCT05899868

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-12

Study Completion Date

2024-05-17

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Airway Complication of Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Testing of device for success during endotracheal intubation
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Time to intubation using FASTER device

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

Group Type OTHER

Time to Intubation using FASTER device

Intervention Type DEVICE

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

Interventions

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Time to Intubation using FASTER device

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

Intervention Type DEVICE

Other Intervention Names

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FASTER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Arvind Chandrakantan

Associate Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arvind Chandrakantan, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Texas Children's Hosppital

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39774053 (View on PubMed)

Other Identifiers

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H50120

Identifier Type: -

Identifier Source: org_study_id