AFrican Resuscitation Ultrasound In Critically-ill Adults (AFRICA)
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|ClinicalTrials.gov Identifier: NCT02794909|
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Shock Dyspnea||Device: Cardiopulmonary ultrasound exam||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study- Ultrasound-guided Resuscitation of Patients Presenting With Shock or Dyspnea to the Emergency Department in a Resource-limited Setting|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Experimental: 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.
Device: Cardiopulmonary ultrasound exam
The cardiopulmonary ultrasound exam consists of a point-of-care ultrasound scan of the heart, lungs, peritoneal cavity, aorta, and femoral veins.
No Intervention: 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.
- 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.
- 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 [ Time Frame: Upon discharge from ED or at 24 hours, whichever comes first ]Impact on treatment will be assessed by comparing the amount of IV fluids given to the two groups as obtained through chart review. The presence or absence of the following therapies (yes/no) will also be obtained via chart review: invasive ventilation, non-invasive ventilation, diuretics, bronchodilators, and vasopressors.
- Number of patients alive [ Time Frame: At 24 hours ]Mortality will be compared between the two groups by documenting the number of patients alive at 24 hours and also at end of the hospital stay (at discharge from hospital).
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): NCT02794909
|Komfo Anokye Teaching Hospital|
|Kumasi, Ghana, 00233|
|Principal Investigator:||Rockefeller Oteng, MD||University of Michigan|