AFrican Resuscitation Ultrasound In Critically-ill Adults

NCT02794909 | Completed

• 1 other identifier: HUM00110695
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock; Dyspnea

Keywords

Point-of-care ultrasound; ED; Low and middle-income country; Echocardiography; Lung ultrasound; Resuscitation

Outcome Measures

Primary Outcomes (1)

• Number of patients with correct diagnosis after initial evaluation in the emergency department

  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.

  Upon discharge from ED or at 24 hours, whichever comes first

Secondary Outcomes (2)

• 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

• Number of patients alive

  At 24 hours

Study Arms (2)

CPUS group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Cardiopulmonary ultrasound exam DEVICE

The cardiopulmonary ultrasound exam consists of a point-of-care ultrasound scan of the heart, lungs, peritoneal cavity, aorta, and femoral veins.

CPUS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller Oteng: lead
• Kwame Nkrumah University of Science and Technology: collaborator
• Komfo Anokye Teaching Hospital: collaborator

Study Sites (1)

Komfo Anokye Teaching Hospital

Kumasi, 00233, Ghana

Location

Related Publications (2)

• Perera P, Mailhot T, Riley D, Mandavia D. The RUSH exam: Rapid Ultrasound in SHock in the evaluation of the critically lll. Emerg Med Clin North Am. 2010 Feb;28(1):29-56, vii. doi: 10.1016/j.emc.2009.09.010.

  PMID: 19945597 BACKGROUND

• Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.

  PMID: 18403664 BACKGROUND

MeSH Terms

Conditions

Shock; Dyspnea

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Rockefeller Oteng, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 9, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)