AnesthesiaPOCUS-RCTNCT03142906
Perioperative Point-of-Care Ultrasound
A study testing Scan in people with Anesthesia and Ultrasound, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Ultrasound, Emergencies
- What is being tested?
- Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 4 Apr 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5A5
Ahmed Hegazy, Assist. Prof, 5198604917, ahegazy@uwo.ca
Osama Sefein, Resident, 2263762815, osama.sefein@londonhospitals.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Ultrasound, Emergencies, Operation, Ultrasonography, Surgery
- Being tested
- Scan
- Keywords
- preoperative, perioperative, point-of-care ultrasound
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScanDiagnostic test
Also called POCUS, Ultrasound examination, Point-of-care ultrasound
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-anaesthesia care unit (PACU) length of stay
Total time (minutes) from postoperative PACU admission to PACU discharge.
Measured: 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
Number of days in hospital from study enrollment to discharge or death.
Measured: 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
New admissions to ICU in the immediate post operative period in patients previously on the ward or in the emergency department.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Use of invasive lines i.e. arterial, central lines or TEE monitoring
Measured: 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
New use or change in pattern of diuretic use in the pre, intra or post operative phases.
Measured: From time of enrollment, up to 2 weeks from randomization.
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).
Measured: From time of enrollment, up to 2 weeks from randomization.
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.
Measured: 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.
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.
Measured: 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.
Number of delays in the patient's surgery for optimization or further work-up.
Measured: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start4 Apr 2017
- Primary completion1 Aug 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel group controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hegazy, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Ahmed Hegazy, Assist. Prof, Principal investigator, Schulich School of Medicine and Dentistry\Anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142906
- Sponsor's protocol ID
- 108613
- Acronym
- POCUS-RCT
- Status last verified
- Jul 2018
- First submitted
- 28 Apr 2017
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22452367Heiberg 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.
PubMed 27346556Canty 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.
PubMed 22950446
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Point-of-Care Ultrasound: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03142906
- Acronym / sponsor ID
- POCUS-RCT / 108613
- Conditions
- Anesthesia, Ultrasound, Emergencies, Operation, Ultrasonography, Surgery
- Keywords
- preoperative, perioperative, point-of-care ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel group controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Scan group | Experimental | Diagnostic Test: ScanPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScanAlso: POCUS, Ultrasound examination, Point-of-care ultrasoundThe 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. | Diagnostic test | Scan group |
Primary outcome
Post-anaesthesia care unit (PACU) length of stay
Time frame: 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.
10 secondary outcomes
Post-randomization hospital length-of-stay
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.
New ICU admission rates
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From time of enrollment, up to 2 weeks from randomization.
Rates of blood work ordered and imaging investigations
Time frame: From time of enrollment, up to 2 weeks from randomization.
Mortality
Time frame: 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.
Time frame: 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.
Time frame: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Background: PubMed 22452367Canty 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.
- Background: PubMed 27346556Heiberg 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.
- Background: PubMed 22950446Canty 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Hegazy, Assist. Prof principal investigator
Schulich School of Medicine and Dentistry\Anaesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scan in people with Anesthesia and Ultrasound, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hegazy, Assist. Prof (5198604917, ahegazy@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-anaesthesia care unit (PACU) length of stay (time frame: From time of PACU admission until the time of transfer from PACU, assessed up to 48 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03142906, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.