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

Primary Purpose

Anesthesia, Ultrasound, Emergencies

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Scan
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anesthesia focused on measuring preoperative, perioperative, point-of-care ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • London Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Scan group

No scan group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Post-anaesthesia care unit (PACU) length of stay
Total time (minutes) from postoperative PACU admission to PACU discharge.

Secondary Outcome Measures

Post-randomization hospital length-of-stay
Number of days in hospital from study enrollment to discharge or death.
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.
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.
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.
Intensiveness of operating room (OR) management
Use of invasive lines i.e. arterial, central lines or TEE monitoring
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.
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).
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.
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.
Rates of OR delays for optimization or further work-up.
Number of delays in the patient's surgery for optimization or further work-up.

Full Information

First Posted
April 28, 2017
Last Updated
July 12, 2018
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03142906
Brief Title
Perioperative Point-of-Care Ultrasound
Acronym
POCUS-RCT
Official Title
Perioperative Point-of-Care Ultrasound: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Ultrasound, Emergencies, Operation, Ultrasonography, Surgery
Keywords
preoperative, perioperative, point-of-care ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized parallel group controlled clinical trial
Masking
Outcomes Assessor
Masking Description
Outcomes assessor blinded to patient assignment.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scan group
Arm Type
Experimental
Arm Description
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.
Arm Title
No scan group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Scan
Other Intervention Name(s)
POCUS, Ultrasound examination, Point-of-care ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-anaesthesia care unit (PACU) length of stay
Description
Total time (minutes) from postoperative PACU admission to PACU discharge.
Time Frame
From time of PACU admission until the time of transfer from PACU, assessed up to 48 hours.
Secondary Outcome Measure Information:
Title
Post-randomization hospital length-of-stay
Description
Number of days in hospital from study enrollment to discharge or death.
Time Frame
From date of randomization until the date of hospital discharge or death from any cause, whichever came first, assessed up to 4 weeks.
Title
New ICU admission rates
Description
New admissions to ICU in the immediate post operative period in patients previously on the ward or in the emergency department.
Time Frame
From time of randomization to the immediate postoperative period, assessed up to 6 hours after the conclusion of surgery.
Title
Rates of detection of unexpected or new pathologies
Description
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.
Time Frame
From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
Title
Change in anesthetic plan based on the scan result
Description
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.
Time Frame
From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
Title
Intensiveness of operating room (OR) management
Description
Use of invasive lines i.e. arterial, central lines or TEE monitoring
Time Frame
During OR time post randomization, assessed until the patient is transferred from the OR to PACU, up to 7 days from randomization.
Title
New or change in peri-operative diuretics use
Description
New use or change in pattern of diuretic use in the pre, intra or post operative phases.
Time Frame
From time of enrollment, up to 2 weeks from randomization.
Title
Rates of blood work ordered and imaging investigations
Description
Frequency of post-randomization blood draws, frequency of post-randomization imaging studies (X-rays, CT's, MRI's, ultrasounds, echoes, and nuclear scans).
Time Frame
From time of enrollment, up to 2 weeks from randomization.
Title
Mortality
Description
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.
Time Frame
From time of enrollment, up to 4 weeks from randomization.
Title
Rates of adequately diagnostic focused cardiac ultrasounds, lung and pleural ultrasounds, and gastric volume/content assessments.
Description
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.
Time Frame
From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
Title
Rates of OR delays for optimization or further work-up.
Description
Number of delays in the patient's surgery for optimization or further work-up.
Time Frame
From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Hegazy, Assist. Prof
Phone
5198604917
Email
ahegazy@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Osama Sefein, Resident
Phone
(226) 376-2815
Email
osama.sefein@londonhospitals.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Hegazy, Assist. Prof
Organizational Affiliation
Schulich School of Medicine and Dentistry\Anaesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Hegazy, Assist. Prof
Phone
5198604917
Email
ahegazy@uwo.ca
First Name & Middle Initial & Last Name & Degree
Osama Sefein, Resident
Phone
2263762815
Email
osama.sefein@londonhospitals.ca
First Name & Middle Initial & Last Name & Degree
Osama Sefein, Resident
First Name & Middle Initial & Last Name & Degree
Kiarash Mohajer, Resident
First Name & Middle Initial & Last Name & Degree
Philip Jones, Assoc. Prof
First Name & Middle Initial & Last Name & Degree
Ramiro Arellano, Assoc. Prof
First Name & Middle Initial & Last Name & Degree
Robert Arntfield, Assist. Prof
First Name & Middle Initial & Last Name & Degree
Wilfredo Puentes, Assist. Prof
First Name & Middle Initial & Last Name & Degree
Jonathan Borger, Assist. Prof

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22452367
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.
Results Reference
background
PubMed Identifier
27346556
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.
Results Reference
background
PubMed Identifier
22950446
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.
Results Reference
background

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Perioperative Point-of-Care Ultrasound

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