Voice Analysis as a Predictor for Difficult Intubations
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|ClinicalTrials.gov Identifier: NCT04105738|
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
|Condition or disease|
|Anesthesia Difficult Intubation Difficult Airway Intubation Speech Dysfunction Surgery|
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.
|Study Type :||Observational|
|Estimated Enrollment :||550 participants|
|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|
Documented history of difficult airways.
Control (Not difficult airways)
Age matched with normal airways to be used as controls
- 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.
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
|Contact: Ryan M DeWolf, MS||(978) firstname.lastname@example.org|
|Contact: Ryan M DeWolf, MS||(774) email@example.com|
|Principal Investigator:||J. M Walz, MD||UMASS Medical School|