- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07833800
Table Height Effects on Spinal Success by Residents in Indonesia
Effects of Operating Table Height on Subarachnoid Block Success by Anesthesia Residents in Faculty of Medicine University of Indonesia
Operating table height influences operator comfort and performance during neuraxial anaesthesia, particularly when the patient is positioned sitting. This study aimed to analyse the effect of operating table height on the success rate and incidence of complications during spinal anesthesia, particularly done by trainees/residents.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients who met the inclusion criteria and did not meet any exclusion criteria were randomised by computer software into two groups according to operating table height - set with puncture site at the level of the operator's umbilicus or the operator's xiphoid process - with group allocation concealed in opaque envelopes. Operators were enrolled by consecutive sampling, consisting of anaesthesiology residents who met the eligibility criteria and were present in the operating theatre during the study period. The outcomes assessed included subarachnoid block success, procedural duration from needle insertion to free flow of cerebrospinal fluid, the need for needle redirection, the need for needle reinsertion, operator comfort, operator posture analysis, and minor complications such as paresthesia or vascular puncture
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Jakarta Special Capital Region
-
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430
- Universitas Indonesia
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- adult patients aged 18-65 years scheduled for elective surgery under neuraxial subarachnoid block anaesthesia
- classified as American Society of Anesthesiologists (ASA) physical status I-III
- operator had performed fewer than 39 prior subarachnoid blocks
Exclusion Criteria:
- body mass index >30 kg/m²
- contraindications to subarachnoid block
- patients' inability to be positioned sitting in accordance with the study protocol
- unwillingness to participate
- operator being unable to perform subarachnoid block according to protocol (injuries etc)
- table height being unable to be adjusted to the target level
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Umbilicus
Patients with table height set so that the puncture site is at operators' umbilicus level |
Table height set so that the puncture site is at operators' umbilicus or xyphoid process level |
|
Experimental: Xyphoid process
Patients with table height set so that puncture site is at the operators' xyphoid process level |
Table height set so that the puncture site is at operators' umbilicus or xyphoid process level |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Procedure sucess
Periodo de tiempo: Periprocedural
|
Determined as free flowing cerebrospinal fluid in spinal needle hub with total procedure time less than 10 minutes, redirection less than 5 minutes, and reinsertion less than 3 times, without occurrence of paresthesia and bloody tao |
Periprocedural
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to sucess
Periodo de tiempo: Periprocedural
|
Time needed from spinal needle-skin contact to free flow of cerebrospinal fluid |
Periprocedural
|
|
Redirection
Periodo de tiempo: Periprocedural
|
Numbers of needle redirection needed at the same puncture site |
Periprocedural
|
|
Reinsertion
Periodo de tiempo: Periprocedural
|
Numbers of spinal needle insertion (after fully pulled out from the skin) |
Periprocedural
|
|
Paresthesia
Periodo de tiempo: Periprocedural
|
Abnormal unpleasant sensation (tingling, burning electric shock, or pain) on lower limbs during spinal procedure |
Periprocedural
|
|
Blood contamination
Periodo de tiempo: Periprocedural
|
Blood observed in spinal needle hub that went away after needle redirection |
Periprocedural
|
|
Bloody tap
Periodo de tiempo: Periprocedural
|
Aspirated blood in spinal needle hub that persists even after needle redirection and necessitate a reinsertion |
Periprocedural
|
|
Subjective comfort assessment
Periodo de tiempo: Periprocedural
|
Subjective assessment of perceived comfort during procedure, asked simply as "comfortable" or "uncomfortable" |
Periprocedural
|
|
Musculoskeletal complaints
Periodo de tiempo: Periprocedural
|
Perceived sensation of aches, pains, tiredness, or stiffness in certain body areas as measured by nordic body map. Minimum value is 0 and maximum value is 28. Higher scores mean worse outcome. |
Periprocedural
|
|
Body postures score
Periodo de tiempo: Periprocedural
|
Assessment of forced posture risk scoring using Rapid Entire Body Assessment. Minimum value is 1 and maximum value is 15. Higher scores mean worse outcome. |
Periprocedural
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rahendra Rahendra, MD, Universitas Indonesia
Publicaciones y enlaces útiles
Publicaciones Generales
- ijerph19010595
Enlaces Útiles
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
- 25-08-1204
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
All IPD collected during trial
Marco de tiempo para compartir IPD
Beginning 3 months and ending 3 years after the publication of results
Criterios de acceso compartido de IPD
De-identified participant data supporting the results reported in this article will be made available upon reasonable request to qualified researchers who provide a methodologically sound proposal via email. A data sharing agreement should be signed.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
- RSC
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. .