Perioperative Point-of-Care Ultrasound

NCT03142906 | Unknown

• 1 other identifier: 108613
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Ultrasound; Emergencies; Operation; Ultrasonography; Surgery

Keywords

preoperative, perioperative, point-of-care ultrasound

Outcome Measures

Primary Outcomes (1)

• Post-anaesthesia care unit (PACU) length of stay

  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.

Secondary Outcomes (10)

• Post-randomization hospital length-of-stay

  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

  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

  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

  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

  During OR time post randomization, assessed until the patient is transferred from the OR to PACU, up to 7 days from randomization.

Study Arms (2)

Scan group

EXPERIMENTAL

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.

Diagnostic Test: Scan

No scan group

NO INTERVENTION

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.

Interventions

Scan DIAGNOSTIC_TEST

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.

Also known as: POCUS, Ultrasound examination, Point-of-care ultrasound

Scan group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Related Publications (3)

• 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.

  PMID: 22452367 BACKGROUND

• 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.

  PMID: 27346556 BACKGROUND

• 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.

  PMID: 22950446 BACKGROUND

MeSH Terms

Conditions

Emergencies

Interventions

Radionuclide Imaging

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Officials

• Ahmed Hegazy, Assist. Prof

  Schulich School of Medicine and Dentistry\Anaesthesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Hegazy, Assist. Prof

CONTACT

5198604917; ahegazy@uwo.ca

Osama Sefein, Resident

CONTACT

(226) 376-2815; osama.sefein@londonhospitals.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor blinded to patient assignment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized parallel group controlled clinical trial

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 8, 2017
• Study Start: April 4, 2017
• Primary Completion: August 1, 2018
• Study Completion: September 30, 2018
• Last Updated: July 16, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)