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Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial (Check-UP)

16 de septiembre de 2016 actualizado por: Todd Rice, Vanderbilt University
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Endotracheal intubation is common in the care of critically ill patients. Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death. The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial. The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.

Tipo de estudio

Intervencionista

Inscripción (Actual)

260

Fase

  • Fase 4

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

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294
        • University of Alabama - Birmingham
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70115
        • Ochsner Medical Center
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Louisiana State University School of Medicine
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt University
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • University of Washington

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Airway management events will be included in which:

  1. Patient is admitted to the Medical Intensive Care Unit (MICU)
  2. Planned procedure is endotracheal intubation
  3. Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow
  4. Administration of sedation and/or neuromuscular blockade is planned
  5. Age ≥ 18 years old

Exclusion Criteria:

Airway management events will be excluded in which:

  1. Operator feels specific patient positioning during intubation is required
  2. Urgency of intubation precludes safe performance of study procedures
  3. Operator feels an alternative pre-procedure checklist or no checklist is required

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Sniffing Position, No Checklist
Patient in the sniffing position without the use of a written checklist
Comparador activo: Sniffing Position, Checklist
Patient in the sniffing position with the use of a written checklist
Procedimiento: Written Checklist
Use of a written checklist pre and peri-intubation
Otros nombres:
  • Lista de Verificación
Comparador activo: Head of Bed Up, No Checklist
Patient with the head of bed up and without the use of a checklist
Procedimiento: Head of Bed Up
Raising the patient's head of bed to 25 degrees
Otros nombres:
  • Patient Positioning
  • Sniff Position
Comparador activo: Head of Bed Up, Checklist
Patient with the head of bed up and with the use of a checklist
Procedimiento: Written Checklist
Use of a written checklist pre and peri-intubation
Otros nombres:
  • Lista de Verificación
Procedimiento: Head of Bed Up
Raising the patient's head of bed to 25 degrees
Otros nombres:
  • Patient Positioning
  • Sniff Position

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Lowest non-invasively measured arterial oxygen saturation between the time of induction or neuromuscular blockade and two minutes after completion of the airway management procedure
Time of Induction through 2 minutes after successful intubation
Lowest Systolic Blood Pressure (Checklist intervention only)
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Lowest non-invasively or invasively measured systolic blood pressure between medication administration and 2 minutes following successful placement of an endotracheal tube (in checklist comparison only)
Time of Induction through 2 minutes after successful intubation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Desaturation
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
Time of Induction through 2 minutes after successful intubation
Incidence of Hypoxemia
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
Time of Induction through 2 minutes after successful intubation
Change in Saturation
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Change in oxygen saturation from baseline to lowest oxygen saturation
Time of Induction through 2 minutes after successful intubation
Grade of First Glottic View
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Cormack-Lehane grade of view on first intubation attempt
Time of Induction through 2 minutes after successful intubation
First Pass Success
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Placement of an endotracheal tube in the trachea after the first insertion of the laryngoscope into the oral cavity without the use of any other devices
Time of Induction through 2 minutes after successful intubation
Number of Intubation Attempts
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Number of attempts required for successful tube placement
Time of Induction through 2 minutes after successful intubation
Time to Intubation
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
Time of Induction through 2 minutes after successful intubation
Need for Assistance
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Incidence of need for additional intubating equipment, second operator
Time of Induction through 2 minutes after successful intubation
Non-hypoxic complications
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Incidence of non-oxygenation complications - composite of all other recorded complications
Time of Induction through 2 minutes after successful intubation
Malposition of Endotracheal Tube
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
Time of Induction through 2 minutes after successful intubation
Repositioning Patient
Periodo de tiempo: Time of Induction through 2 minutes after successful intubation
Incidence of repositioning patient after procedure initiation
Time of Induction through 2 minutes after successful intubation
In-Hospital Mortality
Periodo de tiempo: From enrollment through the earlier of hospital discharge or 365 days
Death before hospital discharge
From enrollment through the earlier of hospital discharge or 365 days
Ventilator-free Days
Periodo de tiempo: From enrollment through study day 28
Days alive and free from mechanical ventilation
From enrollment through study day 28
ICU-Free Days
Periodo de tiempo: From enrollment through study day 28
Days alive and out of the ICU
From enrollment through study day 28

Colaboradores e Investigadores

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

Patrocinador

Vanderbilt University

Investigadores

  • Director de estudio: Todd W Rice, MD, MSc, Vanderbilt University Medical Center

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.

Publicaciones Generales

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 julio de 2015

Finalización primaria (Actual)

1 de septiembre de 2016

Finalización del estudio (Actual)

1 de septiembre de 2016

Fechas de registro del estudio

Enviado por primera vez

6 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

10 de julio de 2015

Publicado por primera vez (Estimar)

14 de julio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

19 de septiembre de 2016

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

16 de septiembre de 2016

Última verificación

1 de septiembre de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 150897

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. .

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