Perioperative Point-of-Care Ultrasound: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Post-anaesthesia care unit (PACU) length of stay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor blinded to patient assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Scan (Diagnostic Test)
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.
结局指标
主要结局
Post-anaesthesia care unit (PACU) length of stay
时间窗: 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.
次要结局
- 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.)
- New or change in peri-operative diuretics use(From time of enrollment, up to 2 weeks from randomization.)
- Rates of blood work ordered and imaging investigations(From time of enrollment, up to 2 weeks from randomization.)
- Mortality(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.(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.(From time of randomization to the time of interpretation of the last POCUS scan, assessed up to 2 weeks from randomization.)
研究者
Ahmed Hegazy
Assistant Professor
Lawson Health Research Institute