Voice Analysis as a Predictor for Difficult Intubations
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01655
- UMASS Memorial - Medical School Campus
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Difficult airways
Documented history of difficult airways.
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Control (Not difficult airways)
Age matched with normal airways to be used as controls
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Audio Samples to Predict Difficult Intubation
Periodo de tiempo: 15-20 minutes
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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.
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15-20 minutes
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: J. M Walz, MD, UMass Medical School
Publicaciones y enlaces útiles
Publicaciones Generales
- Rose DK, Cohen MM. The airway: problems and predictions in 18,500 patients. Can J Anaesth. 1994 May;41(5 Pt 1):372-83. doi: 10.1007/BF03009858.
- Asai T, Koga K, Vaughan RS. Respiratory complications associated with tracheal intubation and extubation. Br J Anaesth. 1998 Jun;80(6):767-75. doi: 10.1093/bja/80.6.767.
- 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. doi: 10.1097/00000542-199303000-00007.
- 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. doi: 10.1378/chest.104.4.1093.
- Robb MP, Yates J, Morgan EJ. Vocal tract resonance characteristics of adults with obstructive sleep apnea. Acta Otolaryngol. 1997 Sep;117(5):760-3. doi: 10.3109/00016489709113474.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- H00012814
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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