Correlation of Neck Dimensions of Airway Evaluation
Correlation of Thyromental Distance And Mandibular Triangle Perpendicular Length With Incisor Vallecular Distance In Adult Pre-Surgical Patients: An Observational Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Preoperative evaluation of the upper airway is vital to the success, safety, and quality of airway access. The evaluation primarily aims to anticipate the course of direct laryngoscopy and intubation (DLI) of the trachea. While assessment of mouth opening, neck extension, and dentition forms the preliminary step of knowing whether DLI is feasible; there are certain other parameters whose evaluation facilitates understanding as to how the actual DLI will turn out. Among the secondary parameters, the linear thyromental distance (TMD) is an important measure that determines how the direct laryngoscopy aspect of conducting DLI will go - in terms of ease-of-laryngoscopy to gain the desired visual access to the view to the vocal cords. The ease of laryngoscopy involves as to how the laryngoscope blade would be able to displace tongue to one side, create forward space enhancement, and reach the vallecula at the base of the tongue; before lifting the epiglottis to view the cords. Though in use for over 4 decades, the TMD suffers from weakness, including, low sensitivity and specificity, not relating to the actual and direct teeth vallecular distance, and getting confounded by neck dimensions (thickness, length), state of dentition, and the tongue size.
The present study is built on the premise that it's the mandibular space to which the tongue is displaced at the time of DLI, the bony mandibular space is more exclusive of the confounders, and that the teeth (lower incisors) vallecular distance represent the actual distance that needs to be predicted.
The present study aims to evaluate TMD and mandibular triangle perpendicular length (MTPL); to know which correlates better with the incisor vallecula distance (IVD). Based on the direction and strength of the correlation measure, a multiple regression equation can then be created to first predict the IVD with external linear measure, and second, based on IVD length prediction, the appropriate laryngoscope blade size can be ascertained.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amitabh Dutta, MD
- Número de teléfono: 00919810848064
- Correo electrónico: duttaamitabh@yahoo.co.in
Ubicaciones de estudio
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, India, 110060
- Reclutamiento
- Sir Ganga Ram Hospital
-
Contacto:
- Amitabh Dutta, MBBS, MD, PGDHR
- Número de teléfono: 9810848064
- Correo electrónico: duttaamitabh@yahoo.co.in
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age 18-65 years
- Males and females
- ASA (American Society of Anaesthesiologists) physical status I and II
- Patients scheduled for elective surgery with controlled ventilation through orotracheal tube conduit
Exclusion Criteria:
- Smokers (those who have smoked ≥100 cigarettes in their lifetime), chewing tobacco dependence or substance abuse
- Submucous fibrosis: progressive fibrosis of the submucosal tissue leading to rigidity, relative trismus, and progressive decrease of mouth opening
- Anticipated difficult airway
- Patients requiring intubation with MacIntosh blade #4 or #5
Dental issues:
- missing tooth (upper/lower incisors, upper/lower premolar)
- crowded dentition: - irregular, misaligned, or overlapping teeth within a relatively small oral cavity
presence of artificial teeth and/or dental implants
• Mandible/mandibular structure related issues:
- Retrognathia: - posterior displacement of the mandible relative to the maxilla or cranial base
- Prognathia: - anterior displacement of the mandible relative to the maxilla or cranial base
- Emergency Surgery
- Those requiring urgent rapid-sequence intubation due to the presence of a full-stomach status secondary to gastro-esophageal reflux disease, diaphragmatic hernia, among others.
- Refusal to informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation of thyromental distance (TMD) and mandibular triangle perpendicular length (MTPL) with incisor vallecular distance (IVD)
Periodo de tiempo: From entry into preoperative area (0 minutes) to time patient is shifted to operating room ( 10-minutes)
|
In all patients thyromental distance (TMD) and mandibular triangle perpendicular length (MTPL) will be measured.
TMD will be measured as a straight line distance between the bony mentum (tip of the chin) and the superior thyroid notch (upper border of the thyroid cartilage).
MTPL will be measured as the perpendicular of the mandibular triangle formed by joining the mental protuberence and point at angle of mandible on either side.
During direct larygngosocpoy when the tip of the laryngoscope blade lies on the vallecula, the distance between the laryngoscope blade tip and the point of laryngoscope blade flange overlying the lower incisors will be measured.
A correlation between TMD and MTPL with IVD if any will be established.
|
From entry into preoperative area (0 minutes) to time patient is shifted to operating room ( 10-minutes)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation of incisor vallecular distance (IVD), mandibular triangle perpendicular length (MTPL), and thyromental distance (TMD) with Macintosh blade (MCB) size#3 length
Periodo de tiempo: From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
|
Macintosh blade size # 3 length will be determined by measuring the linear distance between the tip of the blade and the point where the concave surface of the blade flange joins the heel of the the laryngoscope blade.
A correlation between IVD, MTPL, and TMD with Macintosh blade size # 3 length if any will be established
|
From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
|
|
Cormack and Lehane score
Periodo de tiempo: From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
|
The grade view to the glottic-opening upon direct laryngoscopy will be done using the 4-point Cormack-Lehane grading system (grade 1: entire glottic opening is seen; grade 2: anterior larynx not visualised, only posterior laryngeal aperture is seen; grade 3: only tip of epiglottis is seen; grade 4: neither glottis or epiglottis is visible, only soft palate is seen)
|
From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Amitabh Dutta, MD, Sir Ganga Ram Hospital, New Delhi-110060, India
- Investigador principal: Paridhi Saboo, MBBS, Sir Ganga Ram Hospital, New Delhi-110060, India
- Director de estudio: Nitin Sethi, DNB, Sir Ganga Ram Hospital, New Delhi-110060, India
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- EC/06/26/2981
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .