Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial (PreVent)
12 de septiembre de 2018 actualizado por: Matthew Semler, Vanderbilt University Medical Center
Complications are common during endotracheal intubation of critically ill adults.
Manual ventilation between induction and intubation ("bag-valve-mask" ventilation) has been proposed as a means of preventing hypoxemia, the most common complication of intubation outside the operating room.
Safety and efficacy data, however, are lacking.
PreVent is a randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults.
The primary efficacy endpoint will be the lowest arterial oxygen saturation.
The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end-expiratory pressure in the 24 hours after the procedure.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
PreVent is a prospective, parallel-group, pragmatic, randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults.
The primary aim of the PreVent trial is to compare the effect of manual ventilation between induction and intubation versus no manual ventilation on the lowest arterial oxygen saturation experienced by critically ill adults undergoing endotracheal intubation.
The PreVent trial is anticipated to begin enrollment in January 2017 and will enroll adults undergoing endotracheal intubation with sedation and/or neuromuscular blockade in participating units.
Patients will be randomized 1:1 to manual ventilation versus no manual ventilation.
In the manual ventilation group, manual ventilation using a bag-valve-mask will be provided from the time of induction until the time of endotracheal intubation, except during laryngoscopy.
In the no manual ventilation group, no manual ventilation will be provided between induction and endotracheal intubation, except for the treatment of hypoxemia.
The primary efficacy endpoint will be the lowest arterial oxygen saturation during the procedure.
The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure in the 24 hours after intubation.
Conduct of the trial will be overseen by a Data Safety Monitoring Board.
An interim analysis will be performed after the enrollment of 175 patients.
The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan made publicly available prior to the conclusion of enrollment.
The initial planned enrollment of 350 patients was increased by the Data and Safety Monitoring Board at the interim analysis to a final planned enrollment of 400 patients.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
Inscripción
401
Fase
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
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35294
- The University of Alabama at Birmingham
-
-
Louisiana
-
New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Health System
-
New Orleans, Louisiana, Estados Unidos, 70112
- Louisiana State University School of Medicine
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37209
- Vanderbilt University Medical Center
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98104
- Harborview Medical Center, 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
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:
- Patient is located in a participating unit
- Planned procedure is endotracheal intubation
- Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Exclusion Criteria:
- Urgency of intubation precludes safe performance of study procedures
- Operator feels a specific approach to ventilation between induction and intubation is required
- Pregnant women
- Prisoners
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)
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Comparador activo: Manual Ventilation
Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy.
In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
|
Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy.
In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
Otros nombres:
|
|
Comparador activo: No Manual Ventilation
Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%.
For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
|
Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%.
For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Lowest arterial oxygen saturation
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.
|
Induction to 2 minutes after completion of the airway management procedure
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mortalidad intrahospitalaria
Periodo de tiempo: 28 días
|
28 días
|
|
|
Incidence of lowest oxygen saturation less than 90%
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Incidence of lowest oxygen saturation less than 90% in the time from induction to 2 minutes after completion of the airway management procedure.
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Incidence of lowest oxygen saturation less than 80%
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Incidence of lowest oxygen saturation less than 80% in the time from induction to 2 minutes after completion of the airway management procedure.
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Change in saturation from induction to lowest oxygen saturation
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Change in saturation from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Incidence of desaturation
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Incidence of desaturation as defined by a decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Lowest oxygen saturation in the 24 hours after intubation.
Periodo de tiempo: 24 hours after intubation
|
24 hours after intubation
|
|
|
Highest fraction of inspired oxygen in the 24 hours after intubation.
Periodo de tiempo: 24 hours after intubation
|
24 hours after intubation
|
|
|
Highest positive end expiratory pressure in the 24 hours after intubation.
Periodo de tiempo: 24 hours after intubation
|
24 hours after intubation
|
|
|
Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
Periodo de tiempo: 24 hours after intubation
|
Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
|
24 hours after intubation
|
|
Operator-reported pulmonary aspiration
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Visualization of oropharyngeal or gastric contents in the pharynx, larynx, or trachea between induction and completion of airway management.
|
Induction to 2 minutes after completion of the airway management procedure
|
|
New infiltrate on chest imaging in the 48 hours after intubation
Periodo de tiempo: 48 hours after intubation
|
Determination of new infiltrate will be made by two blinded experts (pulmonary/critical care attendings or fellows) with adjudication by a third expert in the case of discordant results
|
48 hours after intubation
|
|
Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)
Periodo de tiempo: 48 hours after intubation
|
48 hours after intubation
|
|
|
New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
Periodo de tiempo: 24 hours after intubation
|
24 hours after intubation
|
|
|
Incidence of esophageal intubation
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
|
Lowest systolic blood pressure (peri-procedural)
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Lowest systolic blood pressure between induction and two minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
New systolic blood pressure < 65 mmHg or new need for vasopressor
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
New systolic blood pressure < 65 mmHg or new need for vasopressor between medication administration and 2 minutes following successful placement of an endotracheal tube
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Cardiac arrest within one hour of intubation
Periodo de tiempo: One hour after intubation.
|
One hour after intubation.
|
|
|
Death within one hour of intubation
Periodo de tiempo: One hour after intubation
|
One hour after intubation
|
|
|
Cormack-Lehane grade of glottic view
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
|
Operator-assessed difficulty of intubation
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
|
Incidence of successful intubation on the first laryngoscopy attempt
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
|
Number of laryngoscopy attempts
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
|
Time from induction to successful intubation
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
|
Need for additional airway equipment or a second operator
Periodo de tiempo: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
|
Ventilator-free days
Periodo de tiempo: 28 days
|
Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing.
If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28.
If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0. If a patient is discharged while receiving assisted ventilation, VFD will be 0. All data will be censored at the first of hospital discharge or 28 days.
|
28 days
|
|
Intensive care unit-free days
Periodo de tiempo: 28 days
|
ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit in that hospitalization before 28 days.
Patients who are never discharged from the intensive care unit will receive a value of 0. Patients who die before day 28 will receive a value of 0. For patients who return to an ICU and are subsequently discharged prior to day 28, ICU-free days will be counted from the date of final ICU discharge.
All data will be censored at the first of hospital discharge or 28 days.
|
28 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: 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
- Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Zouk AN, Gulati S, Heideman BE, Lester MG, Toporek AH, Bentov I, Self WH, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821. doi: 10.1056/NEJMoa1812405. Epub 2019 Feb 18.
- Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Lester MG, Zouk AN, Gulati S, Stigler WS, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial. BMJ Open. 2018 Aug 10;8(8):e022139. doi: 10.1136/bmjopen-2018-022139.
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)
Inicio del estudio
15 de marzo de 2017
Finalización primaria (Actual)
Finalización primaria
6 de mayo de 2018
Finalización del estudio (Actual)
Finalización del estudio
6 de julio de 2018
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
16 de enero de 2017
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
19 de enero de 2017
Publicado por primera vez (Estimar)
Publicado por primera vez
20 de enero de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
13 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
12 de septiembre de 2018
Última verificación
Última verificación
1 de septiembre de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- IRB #161962
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. .