Perioperative Point-of-Care Ultrasound

Surgery Clinical Trial

— POCUS-RCT  

Official title:

Perioperative Point-of-Care Ultrasound: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03142906
• Other study ID #: 108613
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: July 2018
• Source: Lawson Health Research Institute
• Contact: Ahmed Hegazy, Assist. Prof
• Phone: 5198604917
• Email: ahegazy[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia
• Emergencies
• Operation
• Surgery
• Ultrasonography
• Ultrasound

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-randomization hospital length-of-stay	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.
Secondary	New ICU admission rates	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.
Secondary	Rates of detection of unexpected or new pathologies	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.
Secondary	Change in anesthetic plan based on the scan result	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.
Secondary	Intensiveness of operating room (OR) management	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.
Secondary	New or change in peri-operative diuretics use	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.
Secondary	Rates of blood work ordered and imaging investigations	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.
Secondary	Mortality	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.
Secondary	Rates of adequately diagnostic focused cardiac ultrasounds, lung and pleural ultrasounds, and gastric volume/content assessments.	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.
Secondary	Rates of OR delays for optimization or further work-up.	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.