Validation of the Ramsay scale for invasive procedures under deep sedation in pediatrics.

BACKGROUND: The Ramsay scale is the most widely used scale during pediatric procedures although it has not been formally validated. OBJECTIVE: To validate the Ramsay scale during invasive procedures under sedation in pediatrics. METHODS: A prospective analytic study was conducted in two hospitals. All patients ≥6 months that were undergoing invasive procedures under sedation were enrolled. All were recorded, and these videos were edited and randomized. 150 videos were scored by four observers (a pediatrician, a pediatric intensive care unit nurse, an anesthetist, and an operating room nurse). All videos were scored with the Ramsay scale and University of Michigan Sedation Scale. Observers were blinded to drug administration. Construct validity was measured through Wilcoxon test paired samples after administration of sedatives. Criterion validity, intra-observer reliability, and interobserver correlation were evaluated by comparing the scores of the scales using Spearman's correlation coefficient. Interobserver agreement was measured using the intraclass correlation coefficient. To assess test-retest reliability, 50 videos were randomly selected and reevaluated. RESULTS: Sixty-five patients were included. Construct validity was demonstrated through changes in the Ramsay scale scoring after administration of sedatives (p < .0001). Regarding criterion validity, the Ramsay scale had a high correlation with the UMSS (ρ = 0.621). Intra-observer agreement was ρ = 0.884. The Ramsay scale showed interobserver reliability with an intraclass correlation coefficient = 0.94 when comparing it with the University of Michigan Sedation Scale. Internal consistency was α = 0.91. Regarding applicability, in our study, it was applied in two hospitals in different areas by four professionals from distinct categories. CONCLUSIONS: The Ramsay scale is valid, reliable, and applicable to monitoring sedation for invasive procedures under deep sedation in pediatrics.

[Validity and reliability of the Niño Jesús Hospital procedural sedation-analgesia scale of the under deep sedation-analgesia]. / Validez y fiabilidad de la escala de sedación para procedimientos del Hospital Niño Jesús bajo sedoanalgesia profunda.

INTRODUCTION: The procedural sedation scale of the Niño Jesús Hospital (Madrid) (SSPNJH) has not been validated. PATIENTS AND METHODS: A prospective analytical study was conducted in 2 hospitals on patients ≥ 6 months undergoing invasive procedures using sedation-analgesia with propofol or midazolam and fentanyl. All were monitored using the bispectral index (BIS). Videos were made of each procedure, which were then edited and randomised. A total of 150 videos were rated by four observers using the SSPNJH, the sedation scale of the University of Michigan (UMSS), and the Ramsay Scale (SR). These observers were blinded to the BIS, and at the time of drug administration. To assess test-retest reliability, 50 of the initial 150 randomly selected videos were re-assessed. RESULTS: The study included a total of 65 patients. The within-observer agreement was high (ρ = 0.793). The SSPNJH gave a good interobserver reliability when compared with the UMSS (ICC = 0.88) and the SR (ICC = 0.86), and there was none with the BIS. Internal consistency was moderate (α = 0.68). Construct validity was demonstrated by changes in scores after administering sedatives (p < 0.0001). The SSPNJH had a very low correlation with the BIS (r = -0.166), and a moderate correlation with the UMSS (r = 0.497) and the SR (r = 0.405). As regards the applicability, this scale has been used in two hospitals in five different areas by four professionals of different categories. CONCLUSIONS: The SSPNJH is valid, reliable and applicable for sedation monitoring in invasive procedures under deep sedation-analgesia in paediatric patients. The SSPNJH has worse properties than the UMSS and the SR.

Validez y fiabilidad de la escala de sedación para procedimientos del Hospital Niño Jesús bajo sedoanalgesia profunda / Validity and reliability of the Niño Jesús Hospital procedural sedation-analgesia scale of the under deep sedation-analgesia

INTRODUCCIÓN: La escala de sedación para procedimientos del Hospital Niño Jesús (ESPHNJ) no ha sido validada. PACIENTES Y MÉTODOS: Estudio analítico prospectivo bihospitalario. Se reclutaron prospectivamente pacientes ≥ 6 meses sometidos a procedimientos invasivos bajo sedoanalgesia con propofol o midazolam y fentanilo. Todos fueron monitorizados con el índice biespectral (IB). Se realizaron videos de cada procedimiento, que fueron editados y aleatorizados. Ciento cincuenta videos fueron puntuados por cuatro observadores con la ESPHNJ, la escala de sedación de la Universidad de Michigan (ESUM) y la Escala de Ramsay (ER). Dichos observadores estaban cegados al IB y al momento de administración de fármacos. Para evaluar la fiabilidad test-retest, 50 videos de los 150 iniciales seleccionados aleatorizadamente fueron reevaluados. RESULTADOS: Fueron incluidos 65 pacientes. La concordancia intraobservadores fue alta (ρ = 0,793). La ESPHNJ presentó una fiabilidad interobservador buena al comparar con la ESUM (CCI = 0,88) y con la ER (CCI = 0,86), y no hubo con el IB. La consistencia interna fue moderada (α = 0,68). La validez de constructo fue demostrada por los cambios en las puntuaciones tras administrar sedantes (p < 0,0001). La ESPHNJ tuvo muy baja correlación con el IB (r = -0,166), y correlación moderada con la ESUM (r = 0,497) y la ER (r = 0,405). En relación a la aplicabilidad, nuestro trabajo se ha empleado en dos hospitales en cinco ámbitos distintos por cuatro profesionales de diferentes categorías. CONCLUSIONES: La ESPHNJ es válida, fiable y aplicable para la monitorización de la sedación en procedimientos invasivos bajo sedoanalgesia profunda en pediatría. La ESPHNJ presenta peores propiedades que la ESUM y que la ER

INTRODUCTION: The procedural sedation scale of the Niño Jesús Hospital (Madrid) (SSPNJH) has not been validated. PATIENTS AND METHODS: A prospective analytical study was conducted in 2 hospitals on patients ≥ 6 months undergoing invasive procedures using sedation-analgesia with propofol or midazolam and fentanyl. All were monitored using the bispectral index (BIS). Videos were made of each procedure, which were then edited and randomised. A total of 150 videos were rated by four observers using the SSPNJH, the sedation scale of the University of Michigan (UMSS), and the Ramsay Scale (SR). These observers were blinded to the BIS, and at the time of drug administration. To assess test-retest reliability, 50 of the initial 150 randomly selected videos were re-assessed. RESULTS: The study included a total of 65 patients. The within-observer agreement was high (ρ = 0.793). The SSPNJH gave a good interobserver reliability when compared with the UMSS (ICC = 0.88) and the SR (ICC = 0.86), and there was none with the BIS. Internal consistency was moderate (α = 0.68). Construct validity was demonstrated by changes in scores after administering sedatives (p < 0.0001). The SSPNJH had a very low correlation with the BIS (r = -0.166), and a moderate correlation with the UMSS (r = 0.497) and the SR (r = 0.405). As regards the applicability, this scale has been used in two hospitals in five different areas by four professionals of different categories. CONCLUSIONS: The SSPNJH is valid, reliable and applicable for sedation monitoring in invasive procedures under deep sedation-analgesia in paediatric patients. The SSPNJH has worse properties than the UMSS and the SR