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

12 lipca 2018 zaktualizowane przez: 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.

Przegląd badań

Status

Nieznany

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Kanada
    • Ontario
      • London, Ontario, Kanada, N6A 5A5
        • Rekrutacyjny
        • London Health Sciences Centre
        • Kontakt:
          • Ahmed Hegazy, Assist. Prof
          • Numer telefonu: 5198604917
          • E-mail: ahegazy@uwo.ca
        • Kontakt:
        • Pod-śledczy:
          • Osama Sefein, Resident
        • Pod-śledczy:
          • Kiarash Mohajer, Resident
        • Pod-śledczy:
          • Philip Jones, Assoc. Prof
        • Pod-śledczy:
          • Ramiro Arellano, Assoc. Prof
        • Pod-śledczy:
          • Robert Arntfield, Assist. Prof
        • Pod-śledczy:
          • Wilfredo Puentes, Assist. Prof
        • Pod-śledczy:
          • Jonathan Borger, Assist. Prof

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Diagnostyczny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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 diagnostyczny: 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.
Inne nazwy:
  • POKUS
  • Badanie ultrasonograficzne
  • USG w punkcie opieki
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Post-anaesthesia care unit (PACU) length of stay
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Post-randomization hospital length-of-stay
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Lawson Health Research Institute

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

4 kwietnia 2017

Zakończenie podstawowe (Oczekiwany)

1 sierpnia 2018

Ukończenie studiów (Oczekiwany)

30 września 2018

Daty rejestracji na studia

Pierwszy przesłany

28 kwietnia 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 maja 2017

Pierwszy wysłany (Rzeczywisty)

8 maja 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 lipca 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 lipca 2018

Ostatnia weryfikacja

1 lipca 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 108613

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Nie

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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