Pilot Study- Ultrasound-guided Resuscitation of Patients Presenting With Shock or Dyspnea to the Emergency Department in a Resource-limited Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Number of patients with correct diagnosis after initial evaluation in the emergency department
Study Overview
Brief Summary
The proposed study is a prospective cohort study in which a select group of emergency physicians at Komfo Anokye Teaching Hospital (KATH) in Ghana will be trained in cardiopulmonary ultrasound (CPUS). Following the training, patients who present to the ED with undifferentiated shock and/or dyspnea will either receive usual and customary care supplemented with cardiopulmonary ultrasonography-guided diagnosis and treatment during their initial resuscitation, or usual and customary care alone depending on whether the treating physician has received CPUS training. The main outcomes is the impact of CPUS on correct diagnosis. Information regarding initial treatment strategies, diagnoses and 24-hour mortality will be collected via manual review of paper charts and medical records.
Detailed Description
Methods:
The training protocol and pilot study have been developed through a collaborative effort involving emergency medicine physicians at University of Michigan (UM) and KATH. Select resident physicians (approximately 1/3 of the emergency medicine resident physicians) at KATH will participate in a one-week, hands-on ultrasound course concentrating on solidifying their preexisting skills in ultrasound, with a focus on the RUSH and BLUE protocols for assessment of critically ill patients. Resident physicians will be trained, as attending physicians are not routinely present during the majority of patient evaluations.
The RUSH (Rapid Ultrasound in SHock) protocol was first described in publication in 2010 and has since become widely used throughout the country to aid in identifying the cause of shock for a patient. It is a three-step ultrasound scanning protocol, first evaluating "the pump" or heart, second "the tank" or intravascular volume status, and third "the pipes" or large arteries and veins. Ultrasound findings from the exam are then compared with those typically seen in hypovolemic shock, cardiogenic shock, obstructive shock and distributive shock (1). The BLUE (Bedside Lung Ultrasound in Emergency) protocol was initially published in 2008 as a quick tool to determine diagnosis in acute respiratory failure. Based on ultrasound findings, this scanning protocol provides specific profiles for six main causes of acute respiratory distress, pulmonary edema, pulmonary embolism, pneumonia, chronic obstructive pulmonary disease, asthma, and pneumothorax (2).
As most of the emergency physicians at KATH have previously expressed interest in receiving this training, we will offer training to all physicians in three different cohorts, 1/3 initially, 1/3 part way through the study, and 1/3 at the end. The physicians in the initial training group will be chosen based off their availability and work schedule. The participants will take a test prior to beginning the training and also at the end. They will also be required to pass an OSCE (Objective Structured Clinical Exam) at the end of the week. One week will be allocated for ultrasound training, to allow the physicians to participate and practice their new skills. These select residents will make up the cohort of CPUS-trained physicians.
The pilot study will be conducted over a four-month period in the emergency department at KATH. All patients presenting to the ED will be screened for study inclusion criteria as defined below by a triage nurse, and informed consent will be obtained by research assistants in all patients deemed competent.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Presence of at least one of the following signs or symptoms of hypoperfusion or hypoxia:
- •Unresponsiveness or altered mental status with a GCS <13
- •Diaphoresis
- •Capillary refill >3 seconds
- •Systolic blood pressure <100 at any point between arrival to the ED and IV fluid administration
- •Tachycardia >100 bpm
- •Tachypnea >20/min
- •Pulse oximetry of <92% at any point between arrival to the ED and administration of supplemental oxygen
Exclusion Criteria
- •Chronic low blood pressure, as evidenced by patient report or documentation
- •ACS, determined by ST elevation on EKG (troponin levels not easily available at study site)
- •Significant resuscitative measures prior to enrollment, including defibrillation, ALS medications, or mechanical ventilation
- •Determination of etiology of shock prior to enrollment, such as obvious signs of major trauma or obvious GI bleeding
- •Onset of signs or symptoms of shock after initial evaluation by a physician
Arms & Interventions
CPUS group
The group of patients in the CPUS group will be those who receive a cardiopulmonary ultrasound exam in accordance with a specified CPUS scanning protocol in addition to their routine care. Patients will be in this group if their treating physician has received specific training in the CPUS protocol.
Intervention: Cardiopulmonary ultrasound exam (Device)
Control group
The group of patients in the control group will be those who do not receive an ultrasound exam in accordance with a specified CPUS scanning protocol in addition to their routine care. Patients will be in this group if their treating physician has not received specific training in the CPUS protocol.
Outcomes
Primary Outcomes
Number of patients with correct diagnosis after initial evaluation in the emergency department
Time Frame: Upon discharge from ED or at 24 hours, whichever comes first
Diagnostic accuracy will be assessed by comparing the initial diagnosis, documented on the "second diagnosis checklist" within one hour of first physician contact in the emergency department, and final diagnosis as documented in the patient's chart at the time of discharge or death.
Secondary Outcomes
- Number of patients alive(At 24 hours)
- The amount of IV fluids given to the patient in the emergency department and whether or not the following therapies were employed: invasive ventilation, non-invasive ventilation, diuretics, bronchodilators, and vasopressors(Upon discharge from ED or at 24 hours, whichever comes first)
Investigators
Rockefeller Oteng
Clinical Instructor
University of Michigan