- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07590739
Effect Of Left Head Rotation On Glottic View During Video Laryngoscopy In Obese Adults (LeHeR)
Effect of Left Head Rotation Manoeuvre on Glottic View as Assessed With Percentage of Glottic Opening (POGO) Score During Video Laryngoscopy in Obese Adult Patients: A Prospective Observational Study
This study aims to evaluate whether the Left Head Rotation (LeHeR) maneuver improves visualization of the vocal cords during video laryngoscopy in obese adult patients undergoing general anesthesia. Obesity is associated with increased difficulty in airway management due to excess upper airway soft tissue and altered anatomy, which may impair visualization during intubation.
In this prospective observational study, 50 adult patients with a body mass index (BMI) ≥30 kg/m² will undergo video laryngoscopy using a C-MAC D-blade. The glottic view will be assessed using the Percentage of Glottic Opening (POGO) score in the standard sniffing position and after rotating the head 45 degrees to the left (LeHeR maneuver). A difference in POGO score between the two positions will be analyzed.
Secondary outcomes include ease of intubation, number of attempts, time to successful intubation, and occurrence of complications such as desaturation or airway trauma. The study is expected to determine whether the LeHeR maneuver is a simple and effective technique to improve airway visualization in obese patients.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kalesh Divakar, MD
- Número de teléfono: +968 92452839
- Correo electrónico: drkalesh@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Harihar V Hegde, MD
- Número de teléfono: +968 98845606
- Correo electrónico: drharryhegde@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
- Adult patients aged 18-65 years
- Body mass index (BMI) ≥30 kg/m²
- ASA physical status I-III
- Scheduled for elective surgical procedures under general anesthesia requiring endotracheal intubation
Exclusion Criteria:
- Anticipated need for nasal intubation
- Facial or upper airway pathology preventing laryngoscope insertion
- Cervical spine instability or contraindication to head movement
- Pregnant patients
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 |
|---|---|---|
|
Change in Percentage of Glottic Opening (POGO) Score between Sniffing Position and Left Head Rotation
Periodo de tiempo: Baseline during induction of anaesthesia at the time of video laryngoscopy on Day 1 (single intra-operative assessment)
|
The Percentage of Glottic Opening (POGO) score will be assessed during video laryngoscopy in the sniffing position and after 45-degree left head rotation (LeHeR maneuver).
The difference in POGO score between the two positions will be recorded for each participant.
|
Baseline during induction of anaesthesia at the time of video laryngoscopy on Day 1 (single intra-operative assessment)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to Successful Intubation
Periodo de tiempo: During induction of anesthesia on Day 1
|
Time taken from insertion of the video laryngoscope blade into the oral cavity until successful placement of the endotracheal tube confirmed by capnography.
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During induction of anesthesia on Day 1
|
|
Ease of Intubation
Periodo de tiempo: During tracheal intubation on Day 1
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Ease of intubation assessed using Fremantle score as easy, modified, or unachievable based on number of attempts and need for adjuncts.
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During tracheal intubation on Day 1
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Number of Intubation Attempts
Periodo de tiempo: During tracheal intubation on Day 1
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Number of attempts required to achieve successful tracheal intubation.
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During tracheal intubation on Day 1
|
|
Requirement of Airway Adjuncts
Periodo de tiempo: During tracheal intubation on Day 1
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Need for additional maneuvers such as external laryngeal manipulation, cuff inflation, or use of Magill forceps during intubation.
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During tracheal intubation on Day 1
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Incidence of Peri-intubation Complications
Periodo de tiempo: During induction of anesthesia and tracheal intubation on day 1
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Occurrence of complications such as oxygen desaturation (SpO₂ <95%) or airway trauma during intubation.
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During induction of anesthesia and tracheal intubation on day 1
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- MoH/CSR/26/31800
Plan de datos de participantes individuales (IPD)
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Descripción del plan 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.
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