Intubation in Coronavirus Disease 19 With Level 3 PPE
18 de noviembre de 2021 actualizado por: Dita Aditianingsih, Indonesia University
The Intubation Procedure in COVID-19 Pandemic
The World Health Organization (WHO) declared COVID-19 as a pandemic in April 2020.
COVID-19 first discovered in Wuhan, China in December 2019.
As of May 4th, 2020, the total number of patients in China was 82,880, the number of deaths was 4,633, the death rate was 3.7%.
In Indonesia, until May 4th 2020, there were 11,192 confirmed cases of COVID-19 with a total of 845 deaths.
High transmission and death due to the severe acute respiratory syndrome coronavirus 2, patients with respiratory failure symptoms were suspected of having COVID-19 until declared negative.
A potential and continuing threatening complication is acute respiratory failure.
Patient with Acute Respiratory Distress Syndrome (ARDS) require both respiratory support and oxygen therapy.
The choosing of endotracheal intubation is generally indicated in moderate to severe ARDS.
Apart from respiratory failure, endotracheal intubation is also commonly performed in patients undergoing surgical procedures under general anesthesia for the management of the patient's airway.
To prevent transmission to medical personnel, intubation is carried out using PPE according to the guidelines.
Guidance for intubation in COVID-19 patients is recommended to use a video laryngoscope because it offers several advantages such as assisting glottis visualization and making the intubation operator more distant from the patient's mouth when compared to direct laryngoscopes.
This study aims to see the effect of using PPE and the type of laryngoscope on the intubation process carried out in the COVID-19 pandemic.
This study is a preliminary study aimed at seeing the effect size of the recommended PPE use on the process and success of intubation.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
39
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.
Estudio Contacto
- Nombre: Dita Aditianingsih
- Número de teléfono: +6281316114154
- Correo electrónico: ditaaditia@gmail.com
Ubicaciones de estudio
-
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Reclutamiento
- Cipto Mangunkusumo Hospital
-
Contacto:
- Dita Aditianingsih
- Número de teléfono: +6281316114154
- Correo electrónico: ditaaditia@gmail.com
-
-
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 59 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age 18 to 59 years old
- Undergo elective or emergency surgery using general anesthesia with endotracheal tube
- BMI below 30 kg/m2
Exclusion Criteria:
- Airway difficulty as assessed by preoperative assessment
- Critical patients with unstable hemodynamics
- Suspected or confirmed COVID-19 with ASA 3-5
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 paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group 1 - Level 3 PPE and video laryngoscope
Pre-anesthesia visit aims to assess the participant's physical status based on the American Society of Anesthesiologists score and assessment of the airway.
Researcher then explained about the study and plan for anesthesia using an endotracheal tube and personal protective equipment according to the group.
While in the operating room, the intubation operator was assisted by an assistant who already used appropriate PPE.
Coveralls or hazmat suits and surgical gowns used must match the size.
The intubation operator was resident of Anesthesiology and Intensive Therapy study program (stage II) and accompanied by an independent resident (stage III) and an anesthesiologist on duty.
The operator used level 3 PPE (coverall jumpsuit, face shield, goggles, N95 mask, surgical mask, boot, scrub, and two layered gloves) and video laryngoscope for intubation of the participants.
Researcher was in charge for recording time and event during the intubation process according to the study form.
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The operator used level 3 PPE and video laryngoscope for the intubation process
|
|
Experimental: Group 2 - Level 3 PPE and direct laryngoscope
Pre-anesthesia visit aims to assess the participant's physical status based on the American Society of Anesthesiologists score and assessment of the airway.
Researcher then explained about the study and plan for anesthesia using an endotracheal tube and personal protective equipment according to the group.
While in the operating room, the intubation operator was assisted by an assistant who already used appropriate PPE.
Coveralls or hazmat suits and surgical gowns used must match the size.
The intubation operator was resident of Anesthesiology and Intensive Therapy study program (stage II) and accompanied by an independent resident (stage III) and an anesthesiologist on duty.
The operator used level 3 PPE (coverall jumpsuit, face shield, goggles, N95 mask, surgical mask, boot, scrub, and two layered gloves) and direct laryngoscope for intubation of the participants.
Researcher was in charge for recording time and event during the intubation process according to the study form.
|
The operator used level 3 PPE and direct laryngoscope for the intubation process
|
|
Experimental: Group 3 - Level 2 PPE and direct laryngoscope
Pre-anesthesia visit aims to assess the participant's physical status based on the American Society of Anesthesiologists score and assessment of the airway.
Researcher then explained about the study and plan for anesthesia using an endotracheal tube and personal protective equipment according to the group.
While in the operating room, the intubation operator was assisted by an assistant who already used appropriate PPE.
Coveralls or hazmat suits and surgical gowns used must match the size.
The intubation operator was resident of Anesthesiology and Intensive Therapy study program (stage II) and accompanied by an independent resident (stage III) and an anesthesiologist on duty.
The operator used level 2 PPE (surgical gown/apron, face shield, goggles, N95 mask, surgical mask, boot, scrub, and two layered gloves) and video laryngoscope for intubation of the participants.
Researcher was in charge for recording time and event during the intubation process according to the study form.
|
The operator used level 2 PPE and direct laryngoscope for the intubation process
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total duration of the intubation process
Periodo de tiempo: During the procedure
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The sum amount of time needed to complete an intubation process that includes preoxygenation duration, neuromuscular blocker action, laryngoscopy duration, and endotracheal tube position confirmation with ultrasound
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During the procedure
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Success of intubation process as assessed by number of trials
Periodo de tiempo: During the procedure
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The sum amount of trials needed to successfully place an endotracheal tube to the respiratory system
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During the procedure
|
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Safety as assessed by number of participants experiencing complications
Periodo de tiempo: During the procedure
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Number of participants who experience desaturation of oxygen (below 95%), airway injury, increased blood pressure (over 120/80 mmHg)
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During the procedure
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Dita Aditianingsih, Indonesia University
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)
19 de noviembre de 2021
Finalización primaria (Anticipado)
4 de enero de 2022
Finalización del estudio (Anticipado)
10 de febrero de 2022
Fechas de registro del estudio
Enviado por primera vez
18 de octubre de 2021
Primero enviado que cumplió con los criterios de control de calidad
1 de noviembre de 2021
Publicado por primera vez (Actual)
5 de noviembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de diciembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
18 de noviembre de 2021
Última verificación
1 de noviembre de 2021
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IndonesiaU120
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
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
producto fabricado y exportado desde los EE. UU.
No
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