Perioperative Point-of-Care Ultrasound (POCUS-RCT)
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|ClinicalTrials.gov Identifier: NCT03142906|
Recruitment Status : Unknown
Verified July 2018 by Ahmed Hegazy, Lawson Health Research Institute.
Recruitment status was: Recruiting
First Posted : May 8, 2017
Last Update Posted : July 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Ultrasound Emergencies Operation Ultrasonography Surgery||Diagnostic Test: Scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized parallel group controlled clinical trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcomes assessor blinded to patient assignment.|
|Official Title:||Perioperative Point-of-Care Ultrasound: A Randomized Controlled Trial|
|Actual Study Start Date :||April 4, 2017|
|Estimated Primary Completion Date :||August 1, 2018|
|Estimated Study Completion Date :||September 30, 2018|
Experimental: Scan group
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
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.
No Intervention: No scan group
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.
- 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.
- 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. ]Number of days in hospital from study enrollment to discharge or death.
- 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. ]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 [ Time Frame: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization. ]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 [ Time Frame: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization. ]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 [ Time Frame: During OR time post randomization, assessed until the patient is transferred from the OR to PACU, up to 7 days from randomization. ]Use of invasive lines i.e. arterial, central lines or TEE monitoring
- New or change in peri-operative diuretics use [ Time Frame: From time of enrollment, up to 2 weeks from randomization. ]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 [ Time Frame: From time of enrollment, up to 2 weeks from randomization. ]Frequency of post-randomization blood draws, frequency of post-randomization imaging studies (X-rays, CT's, MRI's, ultrasounds, echoes, and nuclear scans).
- Mortality [ Time Frame: From time of enrollment, up to 4 weeks from randomization. ]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. [ Time Frame: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization. ]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. [ Time Frame: From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization. ]Number of delays in the patient's surgery for optimization or further work-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142906
|Contact: Ahmed Hegazy, Assist. Proffirstname.lastname@example.org|
|Contact: Osama Sefein, Resident||(226) email@example.com|
|London Health Sciences Centre||Recruiting|
|London, Ontario, Canada, N6A 5A5|
|Contact: Ahmed Hegazy, Assist. Prof 5198604917 firstname.lastname@example.org|
|Contact: Osama Sefein, Resident 2263762815 email@example.com|
|Sub-Investigator: Osama Sefein, Resident|
|Sub-Investigator: Kiarash Mohajer, Resident|
|Sub-Investigator: Philip Jones, Assoc. Prof|
|Sub-Investigator: Ramiro Arellano, Assoc. Prof|
|Sub-Investigator: Robert Arntfield, Assist. Prof|
|Sub-Investigator: Wilfredo Puentes, Assist. Prof|
|Sub-Investigator: Jonathan Borger, Assist. Prof|
|Principal Investigator:||Ahmed Hegazy, Assist. Prof||Schulich School of Medicine and Dentistry\Anaesthesia|