Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Bangladeshi Children With Severe Pneumonia (Child-bCPAP)

Feasibility and Acceptability Followed by Effectiveness of Bubble Continuous Positive Airway Pressure for Treatment of Bangladeshi Children With Severe Pneumonia

Background: Feasibility and acceptability of bubble continuous positive airway pressure (CPAP) were not evaluated in childhood severe pneumonia in developing countries at a larger scale.

Objective:

  1. To describe prevailing structural and functional conditions and other operational challenges in nontertiary hospitals in Bangladesh that would need to be addressed in order to introduce bubble CPAP as part of the management of children with severe pneumonia enabling a successful interventional trial.
  2. To develop and test bubble CPAP training materials of relevance to clinical staff providing care for children with severe pneumonia in district general hospitals.
  3. To determine the prevalence of hypoxaemia among hospitalised children with severe pneumonia in non-tertiary/district hospitals, current practices with regard to management and clinical outcome, to support power calculations of a future interventional trial of bubble CPAP for children with severe pneumonia.
  4. To document the early experience, particularly the feasibility and acceptability of introducing bubble CPAP in selected non-tertiary/district hospitals.

Methodology:

Feasibility/demonstration phase will be done as an internal pilot in 2 hospitals. Current treatment practice, facilities, and operational challenges will be evaluated for the introduction, clinical use and maintenance of bubble CPAP.

Outcome:

  1. To describe the structural and functional conditions and operational challenges that may influence the introduction of bubble CPAP.
  2. To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh.
  3. A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes.
  4. A qualitative assessment of the feasibility of introducing bubble CPAP.

Number of children to be enrolled: 20 children in 2 hospitals as an internal pilot (i.e. 10 in each hospital)

Main inclusion criteria: Age between 2 months and 24 months with severe pneumonia and hypoxemia and guardian/parent gives written informed consent to participate in the study.

Statistical Analysis: For feasibility and acceptability study, a descriptive analysis will be performed.

Study duration: 44 months

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

De observación

Inscripción (Actual)

20

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

      • Dhaka, Bangladesh, 1212
        • Institute of Child and Mother Health
      • Kustia, Bangladesh
        • 250 Bedded General Hospital

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

2 meses a 2 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Children aged 2-24 months having hypoxaemia in pneumonia (Pneumonia defined by WHO criteria)

Descripción

INCLUSION CRITERIA

  • Staff:

    • Staff (medical and nursing) employed at the two selected hospitals with duties that include care of children with pneumonia
    • Staff who agree to participate and give written informed consent
  • Children for assessment of hypoxaemia in pneumonia and outcomes:

    • Age between 2 - 24 months
    • Attend one of the two study hospitals for the assessment of pneumonia by hospital clinician.
    • Pneumonia defined by WHO criteria
  • Children receiving bubble CPAP:

    • Age between 2 - 24 months.
    • Diagnosis of pneumonia by a hospital clinician together with hypoxaemia (SpO2<90%).
    • Parent/guardian gives informed consent to participate in the study

EXCLUSION CRITERIA

  • Hospital staff:

    o There will be no exclusion criteria

  • Children for assessment of hypoxaemia in pneumonia and outcomes, and children receiving bubble CPAP:

    • Known congenital heart disease, asthma, pulmonary TB and other chronic respiratory disorders

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
bubble CPAP arm

Oxygen will be delivered by Bubble CPAP device, which will have three components:

  1. Continuous gas flow into the circuit: The gas flow rate required to generate CPAP is usually 5-10 L/min.
  2. A nasal interface connecting the child's airway with the circuit: short nasal prongs are generally used to deliver nasal CPAP. They must be carefully fitted to minimize leakage of air (otherwise, CPAP will not be achieved) .
  3. An expiratory arm with the distal end submerged in water to generate end-expiratory pressure: in bubble CPAP, the positive pressure is maintained by placing the far end of the expiratory tubing in water. The pressure is adjusted by altering the depth of the tube under the surface of the water.

In Bubble CPAP, pressurized oxygen from an oxygen cylinder is delivered to the nasopharynx of the baby. An underwater tube (expiratory arm) that acts as a blow off valve is interposed between the oxygen source and the baby. Adjusting the height of the water column above the exit of the tube can regulate the pressure in the system and the amount of CPAP delivered to the baby. The constant bubbling of gas through the blow off mechanism delivers the bubbling CPAP effect. Oxygen may be delivered by nasal prongs inserted into the nostril of child.

The system has three components:

  1. Continuous gas flow into the circuit: The gas flow rate required to generate CPAP is usually 5-10 L/min.
  2. A nasal interface connecting the child's airway with the circuit:
  3. An expiratory arm with the distal end submerged in water to generate end-expiratory pressure.

The source of oxygen will be either an oxygen concentrator or cylinder, central distribution through pipelines.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The structural, functional and operational challenges will be described
Periodo de tiempo: 44 month
Human resources, Supply chain, logistics equipment maintenance, power failure, disconnection of oxygen with local complications will be identified.
44 month
To have bubble CPAP training materials that can be delivered cheaply and repeatedly to a level of comprehension of staff providing care to children with pneumonia in district general hospitals in Bangladesh
Periodo de tiempo: 44 month
The training module, Standard Operating Procedure, treatment algorithm will be provided to the hospital staff. Hands-on training will be done.
44 month
A quantitative analysis of the incidence of hypoxaemia among hospitalised children with severe pneumonia, current management practices and clinical outcomes
Periodo de tiempo: 44 month
Prevalence, management, mortality, referral, discharge, hospital stay, oxygen therapy duration of severe pneumonia cases will be identified.
44 month
Feasibility and acceptability of introducing bubble CPAP
Periodo de tiempo: 44 month
Challenges related to the introduction of bCPAP, enrollment, patient management with follow-up recording, human resources, respiratory support will be identified.
44 month

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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 (Actual)

1 de diciembre de 2018

Finalización primaria (Actual)

31 de diciembre de 2021

Finalización del estudio (Actual)

31 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

16 de octubre de 2018

Primero enviado que cumplió con los criterios de control de calidad

3 de febrero de 2022

Publicado por primera vez (Actual)

15 de febrero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de febrero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

3 de febrero de 2022

Última verificación

1 de diciembre de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

After the end of the study, data will be analyzed as ter the defined data analysis plan on the protocol. Study results will be shared with other researchers by journal publications, conferences proceedings and dissemination programs

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Suscribir