AFrican Resuscitation Ultrasound In Critically-ill Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02794909
• Date of registration: 23/05/2016
• Prospective Registration: Yes
• Primary sponsor: Rockefeller Oteng
• Public title: AFrican Resuscitation Ultrasound In Critically-ill Adults AFRICA
• Scientific title: Pilot Study- Ultrasound-guided Resuscitation of Patients Presenting With Shock or Dyspnea to the Emergency Department in a Resource-limited Setting
• Date of first enrolment: July 2016
• Target sample size: 180
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02794909
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Ghana

Contacts

• Name: Rockefeller Oteng, MD
• Affiliation: University of Michigan

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dyspnea

Shock

Intervention(s)

Device: Cardiopulmonary ultrasound exam

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Number of patients alive [Time Frame: At 24 hours]

Secondary ID(s)

HUM00110695

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kwame Nkrumah University of Science and Technology

Komfo Anokye Teaching Hospital