Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Voice Analysis as a Predictor for Difficult Intubations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04105738
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
J. Matthias Walz, University of Massachusetts, Worcester

Brief Summary:
To investigate if signal processing can detect subtle changes in speech production clinically relevant to oropharynx anatomy that may provide an objective measure in the assessment of the presumed difficulty of intubation.

Condition or disease
Anesthesia Difficult Intubation Difficult Airway Intubation Speech Dysfunction Surgery

Detailed Description:

The purpose of this study is to investigate whether changes in phonation (sounds coming from vocal cords that occur when a person speaks) can be used as a reliable measure to predict airways that may be difficult to manage in the operating room.

One of the reasons the Preoperative Surgical Assessment (PSE) is performed is to assess subjects for signs of a difficult airway. At this time, none of the assessments have proven to be both highly sensitive and specific. Multiple studies have shown that specific characteristics of a subject's speech can suggest that they may have an issue with the anatomy of the oropharynx (the area consisting of the back of the throat to the vocal cords). Prior research has shown that studying velar vowel sounds, those vowels that require the use of the back of the tongue to pronounce, can be used to predict a disorder called obstructive sleep apnea (a disease associated with difficulty breathing).

The Investigators are trying to determine whether the development of a simple voice study conducted during the PSE visit could alert the Anesthesiologist caring for the subject in the operating room to use the extra precautions provided for people who have a documented history of a difficult airway. It is hoped that the voice analysis test being developed in this study will have the ability to objectively predict a difficult airway for future patients.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Voice Analysis as a Predictor for Difficult Intubations March 26, 2017
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : March 28, 2021
Estimated Study Completion Date : March 28, 2021

Group/Cohort
Difficult airways
Documented history of difficult airways.
Control (Not difficult airways)
Age matched with normal airways to be used as controls



Primary Outcome Measures :
  1. Audio samples [ Time Frame: 15-20 minutes ]
    Recorded audio samples of speech segments into a microphone. Audio sample will be broken down into its signal components using signal-processing methods. The results of the signal processing will be the used to predict a difficult airway.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with a documented history of difficult airways and subjects of the same age (matched for age) with normal airways to be used as controls. Patient are labeled as a difficult airway during their hospitalization, they are given a copy of the difficult airway documentation so the patient should be aware already that they are labeled as a difficult airway.
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Able to provide informed consent
  • A known documented history of having a difficult airway
  • An age-matched control subject with normal airways.

Exclusion Criteria:

  • Unable to consent for themselves
  • Non-English speaking subjects
  • Pregnant Subjects
  • Previous Vocal Cord Surgery
  • Previous Head and neck surgery that would alter anatomy of hypopharynx

We will not include:

  • Prisoners
  • Pregnant women
  • Individuals who are not yet adults (infants, children, teenagers)
  • Adults unable to consent
  • Adults who cannot speak English We will not be enrolling subjects who cannot speak English. The subjects must be able to understand the research team member who is testing them as well as the research paradigm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105738


Contacts
Layout table for location contacts
Contact: Ryan M DeWolf, MS (978) 302-1857 ryan.dewolf@umassmed.edu
Contact: Ryan M DeWolf, MS (774) 303-2649 ryan.dewolf@umassmed.edu

Locations
Layout table for location information
United States, Massachusetts
UMASS Memorial - Medical School Campus Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Ryan M DeWolf, MS    978-302-1857    ryan.dewolf@umassmed.edu   
Contact: Ryan M DeWolf, MS    (774) 303-2649    ryan.dewolf@umassmed.edu   
Sponsors and Collaborators
J. Matthias Walz
Investigators
Layout table for investigator information
Principal Investigator: J. M Walz, MD UMASS Medical School
Publications:
Layout table for additonal information
Responsible Party: J. Matthias Walz, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT04105738    
Other Study ID Numbers: H00012814
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by J. Matthias Walz, University of Massachusetts, Worcester:
Difficult Intubation
Preoperative Surgical Assessment
Speech Dysfunction
Difficult Airway