Aerodigestoscopy (ADS): A retrospective examination of the feasibility, safety, and comfort of a new procedure for the evaluation of physiological disorders of the aerodigestive tract

Abstract

Limited access to comprehensive assessment of physiological disorders of the upper aerodigestive tract by different specialties represents a barrier to care in rural healthcare settings, which may lead to misdiagnosis, underdiagnosis, and increased associated mortality. No single differential diagnostic exam for the comprehensive assessment of all functions of the upper aerodigestive tract is available to bridge this gap. We present a single procedure for assessment of physiological functions of the upper aerodigestive tract including swallow, voice, respiration, and cough while also screening for gastric retention and obstructive sleep apnea which might contribute to these disorders. Our procedure, called Aerodigestoscopy (ADS), represents a procedure incorporating other established exams as integral components to evaluate patients with aerodigestive disorders. Patients who might particularly benefit from our ADS diagnostic algorithm are those in a rural community referred by other health professionals due to complaints of aerodigestive symptoms and signs. We present a brief overview of how the procedure was developed, what it includes, and retrospective safety data from over 18,000 ADS procedures performed over the last 10 years, demonstrating safety and feasibility of this procedure.

Competing Interest Statement

RJA is now the sole owner of Southeastern Biocommunication Associates, LLC which owns the intellectual property rights to the ADS procedure and the ADS software. NB serves as independent Chief Scientist for PN Medical as well as a consulting scientist for Southeastern Biocommunication Associates, LLC.. CG, MM, TM, RM, and AB are consulting scientists for Southeast

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Waiver was granted by WCG IRB, 1019 39th Ave SE Suite 120, Puyallup, WA 98374, USA. IRB Pr. No: 20220812 IRB Study No: 1328192

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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