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NCT05899868 Clinical Trial

Utilization of Airway Stabilizing Rod

Airway Complication of Anesthesia Clinical Trial

— FASTER  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05899868
Other study ID # H50120
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 12, 2023
Est. completion date May 17, 2025

Study information
Verified date November 2023
Source Baylor College of Medicine
Contact Arvind Chandrakantan, MD
Phone 8328245800
Email arvind.chandrakantan@bcm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date May 17, 2025
Est. primary completion date May 17, 2025
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

  • Airway Complication of Anesthesia

Intervention

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.

Locations
Country Name City State
United States Texas Children's Hosppital Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Total time to intubation Time from movement of the device to documentation of end-tidal carbon dioxide waveform through the endotracheal tube. 3 minutes
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