- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01276873
Clinical Variations and Pain Assessment in Newborns Submitted to Intratracheal Aspiration With Open and Closed System
12 de enero de 2011 actualizado por: Federal University of São Paulo
Clinical Variations and Pain Assessment in Newborns Submitted to Intratracheal Aspiration With Open and Closed System.
To compare clinical effects identified in infants undergoing intratracheal aspiration with open and closed systems and verify the presence and intensity of pain in newborns during intratracheal suction, according to the system applied.Clinical, randomized, controlled, and crossover study, performed at two neonatal intensive care units after approval by the ethics committee.
The sample consisted of infants from zero to seven days of age, 26 weeks of gestational age, and the exclusion criteria were use of mechanical ventilation with high-frequency oscillatory, in use of inhaled nitric oxide, in the acute phase of circulatory failure, central nervous system disorders, without reactivity to stimulus, severe asphyxia, Apgar score less than three in the fifth minute, as well as, presence of chromosomal abnormalities and congenital malformations.
After obtaining the informed consent from the responsible, children were randomly allocated into the experimental (CS) and control (OS) groups.
The dependent variables of this study respiratory rate (RR), peripheral oxygen saturation (SatpO2), heart rate (HR), blood pressure (BP) and pain, as well as, of the complementary variables, were collected through observation, the Premature Infant Pain Profile (PIPP) scale application and medical records consultation.
During the data collection the period of variables observation were: T1 (immediately before suctioning), T2 (during suctioning), T3 (immediately after) and T4 (10 minutes after).
To the statistical analysis were applied Fisher exact test, McNemar, Binomial, Student t test, Wilcoxon and Mann Whitney, settling at 0.05 level of significance.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Patients who underwent tracheal intubation require intratracheal tube secretions sucking, and open system (OS) or closed system (CS) can be used, in order to preserve the tracheal tube permeability and an adequate ventilation and blood oxygenation.
Respiratory and hemodynamic complications, as well as, presence of pain can be possibly experienced in newborns submitted to such procedure.
Objectives: To compare clinical effects identified in infants undergoing intratracheal aspiration with OS or CS and verify the presence and intensity of pain in newborns during intratracheal suction, according to the system applied.
Methods: Clinical, randomized, controlled, and crossover study, performed at two neonatal intensive care units after approval by the ethics committee.
The sample consisted of infants from zero to seven days of age, 26 weeks of gestational age, and the exclusion criteria were use of mechanical ventilation with high-frequency oscillatory, in use of inhaled nitric oxide, in the acute phase of circulatory failure, central nervous system disorders, without reactivity to stimulus, severe asphyxia, Apgar score less than three in the fifth minute, as well as, presence of chromosomal abnormalities and congenital malformations.
After obtaining the informed consent from the responsible, children were randomly allocated into the experimental (CS) and control (OS) gruops.
The dependent variables of this study respiratory rate (RR), peripheral oxygen saturation (SatpO2), heart rate (HR), blood pressure (BP) and pain, as well as, of the complementary variables, were collected through observation, the Premature Infant Pain Profile (PIPP) scale application and medical records consultation.
During the data collection the period of variables observation were: T1 (immediately before suctioning), T2 (during suctioning), T3 (immediately after) and T4 (10 minutes after).
To the statistical analysis were applied Fisher exact test, McNemar, Binomial, Student t test, Wilcoxon and Mann Whitney, settling at 0.05 level of significance.
Results: The studied groups did not show significant differences concerning the complementary variables.
There were no statistically significant influences regarding the use of OS and CS of intratracheal suction in any of the dependent variables studied.
Clinical consequences were observed with the use of both systems.
It was demonstrated that immediately after intratracheal aspiration, the newborns had higher RR average in OS (58,4±9,6) group when compared to CS (56,2±5,9).
Average values of SatpO2 were lower in OS (90,5±4,8) group compared to CS (91,6±4,6).
Bradycardia was not verified in any group, however, there was a trend toward higher mean values of HR immediately after intratracheal aspiration, especially with OS (149,5±17,4) compared with the values identified before the procedure (143,2±18,1).
There was low variation in the mean BP value in the two groups during the period of assessment, using both techniques.
Regarding pain it was found that, with OS the average score was 7,9±4,4 and 6,5±3,8 with CS, demonstrating presence of mild to moderate pain.
During the use of OS intratracheal aspiration higher pain scores (p=0,038) where verified in newborn females compared to males, this result was not observed when using CS.
Conclusion: There was no statistically significant difference regarding the clinical implications, the presence and intensity of pain observed in ventilated newborns, according to the use of OS or CS to intratracheal aspiration.
Tipo de estudio
Intervencionista
Inscripción (Actual)
13
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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São Paulo, Brasil, 04024002
- Universidade Federal de Sao Paulo
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São Paulo, Brasil, 04024002
- Federtal university of São Paulo
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 hora a 4 semanas (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- infants from zero to seven days of age.
- 26 weeks of gestational age.
- responsible concordance in participation
Exclusion Criteria:
- use of mechanical ventilation with high-frequency oscillatory.
- use of inhaled nitric oxide.
- acute phase of circulatory failure.
- central nervous system disorders.
- without reactivity to stimulus.
- severe asphyxia.
- Apgar score less than three in the fifth minute.
- Presence of chromosomal abnormalities and congenital malformations
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Closed System
Application of Tracheal aspiration closed system, controlled by the use of Open system to tracheal aspiraiton.
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use of closed system in comparision to open system to tracheal aspiration of nweborns, analyzing pain and climical variations associated.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain response to tracheal suction
Periodo de tiempo: 48 hours
|
There were no statistically significant influences regarding the use of open (OS) or close system (CS) to intratracheal suction in this dependent variable.
With OS the average score was 7,9±4,4 and 6,5±3,8 with CS, demonstrating presence of mild to moderate pain.
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48 hours
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mavilde LG Pedreira, RN, PhD, Federal University of São Paulo
- Silla de estudio: Jaqueline Cardoso, RN, Federal University of São Paulo
- Silla de estudio: Ruth Guinsberg, MD, PhD, Federal University of São Paulo
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2010
Finalización primaria (Actual)
1 de julio de 2010
Finalización del estudio (Actual)
1 de julio de 2010
Fechas de registro del estudio
Enviado por primera vez
11 de enero de 2011
Primero enviado que cumplió con los criterios de control de calidad
12 de enero de 2011
Publicado por primera vez (Estimar)
13 de enero de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de enero de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
12 de enero de 2011
Última verificación
1 de diciembre de 2010
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1094/09
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