Clinical trial NCT03142906: Perioperative Point-of-Care Ultrasound
Official title: Perioperative Point-of-Care Ultrasound: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Ultrasound
Emergencies
Operation
Ultrasonography
Surgery
Keywords: preoperative, perioperative, point-of-care ultrasound
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel group controlled clinical trial
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Post-anaesthesia care unit (PACU) length of stay
timeFrame: From time of PACU admission until the time of transfer from PACU, assessed up to 48 hours.
Secondary outcomes:
measure: Post-randomization hospital length-of-stay
timeFrame: From date of randomization until the date of hospital discharge or death from any cause, whichever came first, assessed up to 4 weeks.
measure: New ICU admission rates
timeFrame: From time of randomization to the immediate postoperative period, assessed up to 6 hours after the conclusion of surgery.
measure: Rates of detection of unexpected or new pathologies
timeFrame: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
measure: Change in anesthetic plan based on the scan result
timeFrame: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
measure: Intensiveness of operating room (OR) management
timeFrame: During OR time post randomization, assessed until the patient is transferred from the OR to PACU, up to 7 days from randomization.
measure: New or change in peri-operative diuretics use
timeFrame: From time of enrollment, up to 2 weeks from randomization.
measure: Rates of blood work ordered and imaging investigations
timeFrame: From time of enrollment, up to 2 weeks from randomization.
measure: Mortality
timeFrame: From time of enrollment, up to 4 weeks from randomization.
measure: Rates of adequately diagnostic focused cardiac ultrasounds, lung and pleural ultrasounds, and gastric volume/content assessments.
timeFrame: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
measure: Rates of OR delays for optimization or further work-up.
timeFrame: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Schulich School of Medicine and Dentistry\Anaesthesia
name: Ahmed Hegazy, Assist. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.