- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03142906
Perioperative Point-of-Care Ultrasound (POCUS-RCT)
Perioperative Point-of-Care Ultrasound: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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London, Ontario, Canadá, N6A 5A5
- Reclutamiento
- London Health Sciences Centre
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Contacto:
- Ahmed Hegazy, Assist. Prof
- Número de teléfono: 5198604917
- Correo electrónico: ahegazy@uwo.ca
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Contacto:
- Osama Sefein, Resident
- Número de teléfono: 2263762815
- Correo electrónico: osama.sefein@londonhospitals.ca
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Sub-Investigador:
- Osama Sefein, Resident
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Sub-Investigador:
- Kiarash Mohajer, Resident
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Sub-Investigador:
- Philip Jones, Assoc. Prof
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Sub-Investigador:
- Ramiro Arellano, Assoc. Prof
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Sub-Investigador:
- Robert Arntfield, Assist. Prof
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Sub-Investigador:
- Wilfredo Puentes, Assist. Prof
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Sub-Investigador:
- Jonathan Borger, Assist. Prof
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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.
|
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:
|
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.
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From time of randomization to the immediate postoperative period, assessed up to 6 hours after the conclusion of surgery.
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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.
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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.
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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.
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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.
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New or change in peri-operative diuretics use
Periodo de tiempo: From time of enrollment, up to 2 weeks from randomization.
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New use or change in pattern of diuretic use in the pre, intra or post operative phases.
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From time of enrollment, up to 2 weeks from randomization.
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Rates of blood work ordered and imaging investigations
Periodo de tiempo: From time of enrollment, up to 2 weeks from randomization.
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Frequency of post-randomization blood draws, frequency of post-randomization imaging studies (X-rays, CT's, MRI's, ultrasounds, echoes, and nuclear scans).
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From time of enrollment, up to 2 weeks from randomization.
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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.
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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.
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From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
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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.
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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
Patrocinador
Investigadores
- Investigador principal: Ahmed Hegazy, Assist. Prof, Schulich School of Medicine and Dentistry\Anaesthesia
Publicaciones y enlaces útiles
Publicaciones Generales
- Canty DJ, Royse CF, Kilpatrick D, Williams DL, Royse AG. The impact of pre-operative focused transthoracic echocardiography in emergency non-cardiac surgery patients with known or risk of cardiac disease. Anaesthesia. 2012 Jul;67(7):714-20. doi: 10.1111/j.1365-2044.2012.07118.x. Epub 2012 Mar 27.
- Heiberg J, El-Ansary D, Canty DJ, Royse AG, Royse CF. Focused echocardiography: a systematic review of diagnostic and clinical decision-making in anaesthesia and critical care. Anaesthesia. 2016 Sep;71(9):1091-100. doi: 10.1111/anae.13525. Epub 2016 Jun 27.
- Canty DJ, Royse CF, Kilpatrick D, Bowyer A, Royse AG. The impact on cardiac diagnosis and mortality of focused transthoracic echocardiography in hip fracture surgery patients with increased risk of cardiac disease: a retrospective cohort study. Anaesthesia. 2012 Nov;67(11):1202-9. doi: 10.1111/j.1365-2044.2012.07300.x. Epub 2012 Sep 5.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
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)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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