Voice Analysis as a Predictor for Difficult Intubations

Surgery Clinical Trial

Official title:

Voice Analysis as a Predictor for Difficult Intubations

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04105738
• Other study ID #: H00012814
• Status: Terminated
• Start date: March 28, 2017
• Est. completion date: February 22, 2021

Study information

• Verified date: January 2022
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: February 22, 2021
• Est. primary completion date: February 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Difficult Airway Intubation
• Difficult Intubation
• Speech Dysfunction
• Surgery

Locations

Country	Name	City	State
United States	UMASS Memorial - Medical School Campus	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
J. Matthias Walz

Country where clinical trial is conducted

United States, 

References & Publications (5)

Asai T, Koga K, Vaughan RS. Respiratory complications associated with tracheal intubation and extubation. Br J Anaesth. 1998 Jun;80(6):767-75. — View Citation

Fiz JA, Morera J, Abad J, Belsunces A, Haro M, Fiz JI, Jane R, Caminal P, Rodenstein D. Acoustic analysis of vowel emission in obstructive sleep apnea. Chest. 1993 Oct;104(4):1093-6. — View Citation

Moller JT, Johannessen NW, Espersen K, Ravlo O, Pedersen BD, Jensen PF, Rasmussen NH, Rasmussen LS, Pedersen T, Cooper JB, et al. Randomized evaluation of pulse oximetry in 20,802 patients: II. Perioperative events and postoperative complications. Anesthesiology. 1993 Mar;78(3):445-53. — View Citation

Robb MP, Yates J, Morgan EJ. Vocal tract resonance characteristics of adults with obstructive sleep apnea. Acta Otolaryngol. 1997 Sep;117(5):760-3. — View Citation

Rose DK, Cohen MM. The airway: problems and predictions in 18,500 patients. Can J Anaesth. 1994 May;41(5 Pt 1):372-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Audio Samples to Predict Difficult Intubation	An audio sample from each participant will be broken down into its signal components using signal-processing methods to evaluate whether there are differences between the two participant groups which may correlate to difficult intubation.	15-20 minutes