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"Barotrauma in Admitted Covid-19 Cases - A Single Center Retrospective Study" (BARCOV)

28 de enero de 2022 actualizado por: Dr Jyoti Barud, Sultan Qaboos University

"Review of Barotrauma in Admitted Covid-19 Cases - A Single Center Retrospective Study From March 2020 Till April 2021."

A retrospective study is planned to find out the incidence and association type of respiratory support with barotrauma in Covid-19 cases admitted in Sultan Qaboos University Hospital. As widely known, Covid-19 affects the respiratory system primarily and is the main cause of admission to hospital. Depending upon the severity, different levels of respiratory support are offered to the patients. Normally patients with viral/bacterial respiratory diseases have a low incidence of barotrauma. Since this disease is new and it has been observed that a significant number of covid-19 patients develop barotrauma, hence it is deemed worthwhile to investigate the matter.

All the patients admitted to the ward, high dependency unit, and intensive care unit will be scanned and those who developed barotrauma (pneumothorax, surgical emphysema, pneumo-pericardium, and pneumo-mediastinum) will be studied in detail and analyzed.

This review is expected to highlight the problem and etiology and we might be able to suggest a management strategy to deal with this problem.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Introduction

Covid-19 is a recently emerged disease affecting the respiratory system primarily but later on, progresses to multisystem involvement. Most of the cases are mild and self-remitting. However, those who develop moderate to severe symptoms require admission. They receive different modalities of respiratory support as per the international guidelines.

The covid-19 typically starts with mild respiratory symptoms with fever, headache, and myalgia. Most of the cases remit after these by 10 days, but around 15% progress to more severe symptoms such as worsening of fever, respiratory symptoms leading to hypoxemia proceeding to complications further on. Correspondingly, the radiological findings peak by 2 weeks after symptom onset. By this point in time, the patients start requiring respiratory support and complications start to emerge as the time passes. Bacterial superinfections, interleukin surge, septic shock are commonly encountered. Recently, at our center rising episodes of barotrauma have been observed.

In the covid era because of huge numbers of admissions, the hospital, as well as ICU beds with respiratory and monitoring resources, are becoming significantly scarce (4). Hence prevention of complications can have a great impact on improving patient outcomes and utilizing hospital resources.

There can be few recognized mechanisms of barotrauma in Covid-19 cases. One of them is alveolar overdistension leading to rupture and barotrauma and the second is a decrease in the caliber of pulmonary vessels increasing pressure gradient causing air leak to the sheath. Positive pressure ventilation leads to an increase in intra-alveolar alveoli. Macklin phenomenon also describes the occurrence of a large pressure gradient between marginal alveoli and lung interstitium leading to barotrauma (5).

Barotrauma is treated by intercostal drain insertion, as well as conservative management by the reduction in airway pressures and increase in oxygen supplementation. Both these can lead to setbacks in a patient's recovery.

This research will identify the etiology of barotrauma and will highlight the preventive strategy to deal with it.

Aim of the Study:

This study aims to examine the incidence of barotrauma, its association with different management strategies so as to suggest modification of preventive and inciting factors. This may improve patient outcomes and conserve hospital resources.

Specific objectives:

  1. To study the incidence of barotrauma in hospitalized Covid-19 cases.
  2. To find the association of factors inciting barotrauma.
  3. To formulate a management plan for the prevention of barotrauma in these cases.

Methodology and study design:

This retrospective study will be conducted in the Department of Anesthesia and ICU at Sultan Qaboos University hospital (SQUH) situated in Muscat, Oman. All admitted patients of Covid-19/SARS-2 between March 2020 to April 2021 will be scanned in the computerized system with the keywords: barotrauma, pneumothorax, surgical emphysema, pneumo-pericardium, and pneumo-mediastinum. A list of cases with these problems will be obtained and the cases will be studied in detail. Data will be obtained from SQUH "Track Care" hospital information system.

Study Population:

Inclusions:

● All admitted patients of Covid-19/SARS-2 between March 2020 to April 2021 t SQUH

Exclusions:

● Patients who develop barotrauma due to central line insertion or trauma prior to admission.

Data Collection and Analyses:

Demographic details, Day of barotrauma, comorbidities, type of respiratory support, other treatment modalities, and covid laboratory profile: ferritin, LDH, CRP, IL-6, fibrinogen, white cell count, and lymphocyte counts.

SPSS software (version 23) will be used to collect and analyze data. Obtaining the significance of association will be through using students' t-test, fisher's exact test, and Chi-square test. P-value < 0.05 will be considered significant.

Tipo de estudio

De observación

Inscripción (Actual)

251

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

      • Muscat, Omán, 123
        • Sultan Qaboos University 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

18 años a 89 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

A total of 2159 Covid-19 PCR-positive patients were identified in consecutive participant sampling at the University hospital during the study period. Out of these 63 patients were found to develop barotrauma. Matched controls were identified and a total of 322 cases was scanned. 61 patients were discharged from the emergency department after initial treatment, 1 patient left against medical advice and 2 patients died before they could be admitted to the ward and 7 were shifted to other hospitals, and their follow-up was lost, hence a total of 251 patients were finally studied. 63 patients were "Cases" and 188 were "Controls" in the ratio of 1:3 cases: controls.

Descripción

Inclusion Criteria:

  • All admitted adult patients with covid PCR positive result
  • Those who developed barotrauma were labeled as "Cases" and those without barotrauma were "Controls".

Exclusion Criteria:

  • Adult patients with covid PCR positive result who were discharged from Emergency department.
  • Adult patients with covid PCR positive result who died or left against medical advice before admission to ward/ICU
  • Adult patients with covid PCR positive result who were shifted to other hospitals and their follow up could not be completed.

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
Cases
Admitted Covid-19 cases who developed Barotrauma
Controls
Admitted Covid-19 cases who did not develop Barotrauma, matched with Cases with respect to age and sex.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Barotrauma in admitted Covid-19 cases
Periodo de tiempo: 1-102 days
Incidence of Barotrauma in admitted Covid-19 cases between March 2020 till April 2021
1-102 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Association of factors with Barotrauma in admitted Covid-19 cases
Periodo de tiempo: 1-102 days
Association of factors with Barotrauma in admitted Covid-19 cases
1-102 days
Mortality with cases versus controls
Periodo de tiempo: 1-102 days
Mortality with cases versus controls
1-102 days
Ventilation days of cases versus controls
Periodo de tiempo: 1-65 days
Ventilation days
1-65 days

Colaboradores e Investigadores

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

Investigadores

  • Director de estudio: Jyoti Burad, Sultan Qaboos University Hospital

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)

24 de junio de 2021

Finalización primaria (Actual)

30 de noviembre de 2021

Finalización del estudio (Actual)

30 de noviembre de 2021

Fechas de registro del estudio

Enviado por primera vez

28 de enero de 2022

Primero enviado que cumplió con los criterios de control de calidad

28 de enero de 2022

Publicado por primera vez (Actual)

31 de enero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

31 de enero de 2022

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

28 de enero de 2022

Última verificación

1 de enero de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

IPD might be made available on individual request

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. .

Ensayos clínicos sobre COVID-19

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