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

Effect of Prone Positioning on the Severity of COVID-19 Pneumonia and Acute Respiratory Distress Syndrome. (COVID-19)

5 de junio de 2022 actualizado por: Hamza Javed, Ayub Medical College, Abbottabad

Effect of Prone Positioning on the Severity of COVID-19 Pneumonia and Acute Respiratory Distress Syndrome. A Randomized Clinical Trial

With this research, we are aiming at finding out the effectiveness of prone positioning in this region population affected by moderate pneumonia due to covid 19 infection so that the hospital staff and doctors may be encouraged with facts and data to use such an easy maneuver to stabilize patient's oxygen saturation as we believe that prone positioning does have a protective effect against severe disease and has an effect on reducing mortality if patients are encouraged for prone positioning with proper technique and for suitable time duration as has been observed in the clinical practice in the covid wards. Therefore, we want to assess the effects of 8 hours per day prone positioning the patients with confirmed covid pneumonia admitted in the covid wards.

Descripción general del estudio

Descripción detallada

Currently, Pakistan and specifically the Hazara division is being badly hit by the fourth wave of covid 19. Patients are mostly presenting with covid pneumonia with or without other complications such as ARDS, ARF, and shock. A nationwide vaccination drive has been launched in collaboration with the WHO but the general population's response towards getting self-vaccinated is not very much appreciable.

It has been reported in a study from new jersey that awake prone positioning in a spontaneously breathing patients can improve arterial blood oxygen saturation.1 another systematic review of 50 articles, including a total of 2994 patients among which 921 patients were managed with awake prone positioning and the rest by usual care, reported significant improvement in oxygenation parameters with prone positioning. They also concluded that it did not reduce the invasive ventilation rate. 2 another meta-analysis of randomized controlled trials suggested that prone positioning has a protective effect on the lungs by improving oxygenation and can reduce mortality in patients with acute respiratory distress syndrome (ARDS) but also suggested further investigations through randomized clinical trials into the effectiveness of prone positioning in covid 19 associated ARDS. 3

In a report of original investigations, K Solverson et al. concluded that prolonged prone positioning improved oxygenation parameters and reduce mortality but the patients could not tolerate such a long duration. They also suggested a further investigation into the methods to improve the tolerability of awake prone positioning and its long-term benefits.4 Gattinoni L et al. in their multisystem randomized clinical trial where they prone positioned patients for 6 hours per day for a period of 10 days reported that it does improve the oxygenation but it does not improve survival.5 In a randomized controlled trial, Taccone P, reported similar 28th-day and 6th-month outcomes in patients with moderate and severe hypoxemia.6 similar results were reported by Martha A. Q. Curley et al in their study on the pediatric population.7 Guerin C et al. reported no beneficial effects on survival although they did conclude that prone positioning has a protective effect against ventilator-associated pneumonia.8 Ehrmann S et al. in their randomized, controlled, multinational, open-label meta-trial, reported that awake prone positioning of patients with hypoxaemic respiratory failure due to COVID-19 reduces the incidence of treatment failure and the need for intubation without any signal of harm. Their results support the routine use of the prone positioning technique in patients with COVID-19. 9 Binda F et al. in their cross-sectional study on the complications related to prone positioning although considered safe and feasible but reported the prevalence of many complications associated with prone positioning such as pressure ulcers, bleeding from the upper airways, and medical device displacement.10. Malik GR et al. also reported some peripheral nerve injuries especially in the arms after their experience with prone positioning of patients in four tertiary care hospitals.11 None of these complications are immediately fatal and can be managed easily while the patients are in the hospital.

With this research, we are aiming at finding out the effectiveness of prone positioning in this region population affected by moderate pneumonia due to covid 19 infection so that the hospital staff and doctors may be encouraged with facts and data to use such an easy maneuver to stabilize patient's oxygen saturation as we believe that prone positioning does have a protective effect against severe disease and has an effect on reducing mortality if patients are encouraged for prone positioning with proper technique and form suitable time duration as has been observed in the clinical practice in the covid wards. Therefore, we want to assess the effects of 8 hours per day prone positioning the patients with confirmed moderately severe covid pneumonia admitted in the covid wards.

Tipo de estudio

Intervencionista

Inscripción (Actual)

72

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

    • KPK
      • Abbottābād, KPK, Pakistán, 22040
        • Ayub Teaching 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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Confirmed covid pneumonia/ acute respiratory distress syndrome cases

Exclusion Criteria:

  • consent denial, patients having contraindications to prone positioning such as shock, acute bleeding, trauma, spinal instability, raised Intracranial Pressure, sternal/ tracheal surgery, Female pregnant patients in 2nd and 3rd trimester

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Prone Positioned Group

Intermittent prone positioning for a total of eight hours per day for seven days. Each cycle of prone positioning should not be less than 30 minutes and note more than 3 hours at one time.

Rest of the treatment as per protocols of the institution

intermittent prone positioning for eight hours per day for seven days. each cycle should not be less than 30 minutes or more than 3 hours.
Otros nombres:
  • Prone Positioning
Sin intervención: Control Group
Treatment as per institutional protocols- the protocols does not involve prone positioning of the patients

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
percentage of patients dying COVID-19 pneumonia/ ARDS in both groups
Periodo de tiempo: Three months
Effect of prone positioning on the mortality of patients suffering from covid pneumonia/ acute respiratory distress syndrome
Three months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Respiratory physiology- mean PaO2 and Mean respiratory rate of both groups at first, seventh and fiourteenth day of admission
Periodo de tiempo: Three months
effects on the PaO2, respiratory rate and mask type (supplemental oxygen requirement)
Three months

Colaboradores e Investigadores

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

Colaboradores

Investigadores

  • Investigador principal: Hamza Javed, MBBS, Ayub Teaching Hospital, ABbottabad

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el 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)

15 de octubre de 2021

Finalización primaria (Actual)

28 de febrero de 2022

Finalización del estudio (Actual)

28 de febrero de 2022

Fechas de registro del estudio

Enviado por primera vez

2 de junio de 2022

Primero enviado que cumplió con los criterios de control de calidad

2 de junio de 2022

Publicado por primera vez (Actual)

6 de junio de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de junio de 2022

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

5 de junio de 2022

Última verificación

1 de junio de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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