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Perioperative Point-of-Care Ultrasound (POCUS-RCT)

12 de julio de 2018 actualizado por: Ahmed Hegazy, Lawson Health Research Institute

Perioperative Point-of-Care Ultrasound: A Randomized Controlled Trial

The goal of this study is to assess the impact of perioperative point-of-care ultrasound (POCUS) assessment on patient-important outcomes (e.g. hospital length of stay, length of stay in recovery, mortality etc.) and perioperative patient management strategies, in patients undergoing non-elective non-cardiac surgeries.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Preoperative patients undergoing emergency non-cardiac surgery will be approached for study recruitment and participation. Study participants will be randomized to receive, or not, a preoperative POCUS exam as part of their routine preoperative assessment. Patients randomized to receiving a POCUS exam will undergo a protocolized focused cardiac ultrasound, lung and pleural ultrasound and a gastric volume and content ultrasound assessment. Results of this exam will be disclosed to the anesthesiologist and primary care team. Randomization will be stratified by the presence of any sign(s) of cardiorespiratory failure. Signs of cardiorespiratory failure are defined as: systolic blood pressure <90 mmHg, heart rate>100, respiratory rate >24, Oxygen saturation <90%, requirement of supplemental oxygen or mechanical ventilation, new requirement of loop diuretics in current hospital admission, chest pain, newly diagnosed ECG changes, requirement of vasoactive drugs, signs of pre-renal azotemia (BUN:creatinine ratio >20). Outcome data will be collected prospectively. Investigators performing and interpreting the scan will disclose the results to the care team but will not participate in patient care. Primary and secondary outcome data collection will be performed by an investigator blinded to patient assignment. The primary outcome is post anesthetic care unit length-of-stay. The secondary outcomes are post-randomization hospital length of stay, number of operating room (OR) delays for optimization, alterations in anesthetic management (using a brief anesthesiologist-administered survey), intensiveness of OR management (invasive blood pressure monitoring, central venous pressure monitoring, intraoperative TEE), new peri-operative diuretic use, new intensive care admission rates, mortality during this admission, amount/frequency of postoperative investigations, rates of detection of new pathologies identified by preoperative POCUS exam and the rates of adequately diagnostic POCUS studies.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

100

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

  • Canadá
    • Ontario
      • London, Ontario, Canadá, N6A 5A5
        • Reclutamiento
        • London Health Sciences Centre
        • Contacto:
          • Ahmed Hegazy, Assist. Prof
          • Número de teléfono: 5198604917
          • Correo electrónico: ahegazy@uwo.ca
        • Contacto:
        • Sub-Investigador:
          • Osama Sefein, Resident
        • Sub-Investigador:
          • Kiarash Mohajer, Resident
        • Sub-Investigador:
          • Philip Jones, Assoc. Prof
        • Sub-Investigador:
          • Ramiro Arellano, Assoc. Prof
        • Sub-Investigador:
          • Robert Arntfield, Assist. Prof
        • Sub-Investigador:
          • Wilfredo Puentes, Assist. Prof
        • Sub-Investigador:
          • Jonathan Borger, Assist. Prof

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:

  • Patients aged >17 years
  • Undergoing urgent or emergent non-cardiac surgery classified as intermediate or high risk according to American Heart Association(AHA)/American College of Cardiology(ACC) guidelines.

These include vascular surgeries (supra or infra-inguinal), intraperitoneal surgeries, intra-thoracic surgeries, head and neck surgeries, spine surgeries, urologic surgeries, and proximal extremity orthopedic surgeries. Peripheral extremity surgeries (wrist or below, and ankle or below), in addition to appendectomies and cholecystectomy surgeries will be excluded from this study.

Exclusion Criteria:

  • Patients scheduled for elective or pre-booked surgeries
  • Patients undergoing cardiac surgeries
  • Patients undergoing low risk procedures e.g. endoscopic procedures, superficial skin, subcutaneous tissue, breast, ophthalmic, and ambulatory surgeries
  • Patients undergoing orthopedic peripheral extremity surgeries (e.g. ankle, wrist, hand, foot)
  • Patients who have had an echo during the current hospital admission prior to recruitment.
  • Patients where the investigator performing or over-reading the POCUS scan is required to participate directly in perioperative patient care (e.g. anesthesiologist co-investigator performing or over-reading scan is on-call for this emergency case)

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: Diagnóstico
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Scan group
Patients randomized to the scan group (intervention arm) will receive a preoperative point-of-care ultrasound (POCUS) exam as an adjunct to their preoperative assessment, the results of which will be disclosed to the anesthesiologist and the patient care team. This POCUS exam will include a focused cardiac ultrasound, a lung and pleural ultrasound, and a gastric volume and content ultrasound assessment. Patients randomized to this arm may also receive repeat POCUS exams as needed and as clinical conditions change. These repeat exams may be requested by the anesthesiologist or patient care team.
Prueba de diagnóstico: Scan
The preoperative point of care ultrasound includes a protocolized focused cardiac ultrasound, lung and pleural ultrasound and a gastric volume and content ultrasound assessment, all of which will be performed as an adjunct to the anesthesiologist's assessment. The result of this ultrasound examination will be disclosed to the anesthesiologist and patient care teams. Repeat ultrasounds may be done as the patient's clinical condition changes, or as requested by the anesthesiologist or patient care team.
Otros nombres:
  • POCUS
  • Examen de ultrasonido
  • Ultrasonido en el punto de atención
Sin intervención: No scan group
Patients randomized to no scan (control arm) will not receive a preoperative point-of-care ultrasound exam. Patients in this arm will receive the standard-of-care; a routine preoperative assessment and physical examination by their attending anesthesiologist.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Post-anaesthesia care unit (PACU) length of stay
Periodo de tiempo: From time of PACU admission until the time of transfer from PACU, assessed up to 48 hours.
Total time (minutes) from postoperative PACU admission to PACU discharge.
From time of PACU admission until the time of transfer from PACU, assessed up to 48 hours.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Post-randomization hospital length-of-stay
Periodo de tiempo: From date of randomization until the date of hospital discharge or death from any cause, whichever came first, assessed up to 4 weeks.
Number of days in hospital from study enrollment to discharge or death.
From date of randomization until the date of hospital discharge or death from any cause, whichever came first, assessed up to 4 weeks.
New ICU admission rates
Periodo de tiempo: From time of randomization to the immediate postoperative period, assessed up to 6 hours after the conclusion of surgery.
New admissions to ICU in the immediate post operative period in patients previously on the ward or in the emergency department.
From time of randomization to the immediate postoperative period, assessed up to 6 hours after the conclusion of surgery.
Rates of detection of unexpected or new pathologies
Periodo de tiempo: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
New cardiac, pulmonary or gastric pathology detected by preoperative POCUS not known to be present previously. Examples include valve lesions, resting regional wall motion abnormalities, ventricular dysfunction, ventricular hypertrophy, pulmonary edema, consolidation and/or pleural effusion. This will be calculated only for participants randomized to the Scan Group.
From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
Change in anesthetic plan based on the scan result
Periodo de tiempo: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
A survey will be administered to the anesthesiologist caring for the patient asking whether the POCUS exam findings influenced the anesthetic plan for the patient. If the answer is "yes, it did influence the anesthetic plan", subsequent questions will explore how it influenced anesthetic management. These will include questions of whether it influenced fluid management, anesthetic technique, choice of invasive lines, choice or dose of induction agents, or delay of surgery for optimization or further work-up. This will be calculated only in participants randomized to the Scan Group.
From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
Intensiveness of operating room (OR) management
Periodo de tiempo: During OR time post randomization, assessed until the patient is transferred from the OR to PACU, up to 7 days from randomization.
Use of invasive lines i.e. arterial, central lines or TEE monitoring
During OR time post randomization, assessed until the patient is transferred from the OR to PACU, up to 7 days from randomization.
New or change in peri-operative diuretics use
Periodo de tiempo: From time of enrollment, up to 2 weeks from randomization.
New use or change in pattern of diuretic use in the pre, intra or post operative phases.
From time of enrollment, up to 2 weeks from randomization.
Rates of blood work ordered and imaging investigations
Periodo de tiempo: From time of enrollment, up to 2 weeks from randomization.
Frequency of post-randomization blood draws, frequency of post-randomization imaging studies (X-rays, CT's, MRI's, ultrasounds, echoes, and nuclear scans).
From time of enrollment, up to 2 weeks from randomization.
Mortality
Periodo de tiempo: From time of enrollment, up to 4 weeks from randomization.
In-hospital post randomization mortality rate. Patients dying after transfer to another acute care hospital will also be counted as an in-hospital post randomization mortality.
From time of enrollment, up to 4 weeks from randomization.
Rates of adequately diagnostic focused cardiac ultrasounds, lung and pleural ultrasounds, and gastric volume/content assessments.
Periodo de tiempo: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
An adequately diagnostic focused cardiac ultrasound will be defined as a scan having two or more views showing at least 3 cardiac chambers with diagnostic quality. An adequately diagnostic lung and pleural scan will demonstrate a clear aeration pattern in both hemithoraces with visualization of the diaphragm or a corresponding curtain sign. An adequately diagnostic gastric ultrasound will be done in right lateral decubitus and demonstrate the liver in the near field, a great vessel (aorta or IVC) in the far field, and the stomach antrum deep to the liver in the near to mid-field with visualization of the hypo-echoic muscularis propria. These outcomes will be examined only in participants randomized to the Scan Group.
From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
Rates of OR delays for optimization or further work-up.
Periodo de tiempo: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
Number of delays in the patient's surgery for optimization or further work-up.
From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.

Colaboradores e Investigadores

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

Patrocinador

Lawson Health Research Institute

Investigadores

  • Investigador principal: Ahmed Hegazy, Assist. Prof, Schulich School of Medicine and Dentistry\Anaesthesia

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 (Actual)

4 de abril de 2017

Finalización primaria (Anticipado)

1 de agosto de 2018

Finalización del estudio (Anticipado)

30 de septiembre de 2018

Fechas de registro del estudio

Enviado por primera vez

28 de abril de 2017

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2017

Publicado por primera vez (Actual)

8 de mayo de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de julio de 2018

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

12 de julio de 2018

Última verificación

1 de julio de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 108613

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. .

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