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

12 juillet 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recrutement
        • London Health Sciences Centre
        • Contact:
          • Ahmed Hegazy, Assist. Prof
          • Numéro de téléphone: 5198604917
          • E-mail: ahegazy@uwo.ca
        • Contact:
        • Sous-enquêteur:
          • Osama Sefein, Resident
        • Sous-enquêteur:
          • Kiarash Mohajer, Resident
        • Sous-enquêteur:
          • Philip Jones, Assoc. Prof
        • Sous-enquêteur:
          • Ramiro Arellano, Assoc. Prof
        • Sous-enquêteur:
          • Robert Arntfield, Assist. Prof
        • Sous-enquêteur:
          • Wilfredo Puentes, Assist. Prof
        • Sous-enquêteur:
          • Jonathan Borger, Assist. Prof

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Test diagnostique: 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.
Autres noms:
  • POCU
  • Examen échographique
  • Échographie au point de service
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Post-anaesthesia care unit (PACU) length of stay
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Post-randomization hospital length-of-stay
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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.
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Lawson Health Research Institute

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 avril 2017

Achèvement primaire (Anticipé)

1 août 2018

Achèvement de l'étude (Anticipé)

30 septembre 2018

Dates d'inscription aux études

Première soumission

28 avril 2017

Première soumission répondant aux critères de contrôle qualité

3 mai 2017

Première publication (Réel)

8 mai 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juillet 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juillet 2018

Dernière vérification

1 juillet 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 108613

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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