Development of Upper Aerodigestive Tract Splint

University Health Network, Toronto7 enrolled

Overview

The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment.

This is a pilot study of 30 patients. We will tabulate the data for efficacy, there will be no statistical analysis.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Splints

Interventions

Use of Splint for UADT VisualizationDEVICE

The use of a splint to assist the patient and the surgeon with UADT procedures.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Require a procedure involving the upper aerodigestive tract (UADT) Exclusion Criteria: * Prior surgery to tongue or mouth that precludes the use of the splint * Trismus with mouth opening that does not allow for use of the splint * TMJ dysfunction that precludes the use of the splint * Allergy to local anesthetic

Locations (1)

University Health Network

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Patient Splint Satisfaction Questionnaire

Self-administered, 6-item questionnaire to evaluate splint satisfaction.

Time frame: Immediately after the intervention/procedure/surgery

Physician Splint Satisfaction Questionnaire

A 14-item questionnaire to evaluate the surgeon satisfaction with the splint.

Time frame: Immediately after the intervention/procedure/surgery

Data from ClinicalTrials.gov

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