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AFrican Resuscitation Ultrasound In Critically-ill Adults (AFRICA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794909
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : February 23, 2017
Sponsor:
Collaborators:
Kwame Nkrumah University of Science and Technology
Komfo Anokye Teaching Hospital
Information provided by (Responsible Party):
Rockefeller Oteng, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Shock Dyspnea Device: Cardiopulmonary ultrasound exam Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Ghana
Komfo Anokye Teaching Hospital
Kumasi, Ghana, 00233
Sponsors and Collaborators
Rockefeller Oteng
Kwame Nkrumah University of Science and Technology
Komfo Anokye Teaching Hospital
Investigators
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Principal Investigator: Rockefeller Oteng, MD University of Michigan
Publications:
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Responsible Party: Rockefeller Oteng, Clinical Instructor, University of Michigan
ClinicalTrials.gov Identifier: NCT02794909    
Other Study ID Numbers: HUM00110695
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rockefeller Oteng, University of Michigan:
Point-of-care ultrasound
ED
Low and middle-income country
Echocardiography
Lung ultrasound
Resuscitation
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory