Harnessing Alternative Resources to Aid Kenyans With Acute Illness (HARAKA-2)

Aga Khan University

Status: Unknown

Conditions: Cardiorespiratory Failure

Treatments: Device: Nurse-performed Focused cardiac ultrasound (FoCUS); Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04344418

31-20

Details and patient eligibility

About

Kenya does not have enough experts to perform heart scans in patients who are very sick and in need of urgent intervention. The purpose of this research is to find out whether training Kenyan nurses to perform basic heart scans would shorten the time it takes to know whether the heart and lungs are working normally in very sick patients, to guide treatment. Patients will be placed into one of two groups: One group will have a quick scan of the heart and lungs carried out by trained nurses to see how well these organs are working, in addition to receiving the normal care offered at the hospital. The other group will receive the normal care offered in the hospital only and will not have a scan performed by these nurses. The time it takes to make a diagnosis between the two groups will then be compared. Should the group that has heart scans by nurses be found to spend less time waiting for a diagnosis to be made, more nurses in Kenya will be trained to provide this service, to minimise delays in our emergency departments.

Full description

Echocardiography is a useful, non-invasive diagnostic tool in time-critical emergencies. A national shortage of cardiologists and of doctors in Kenya however further compounds the problem of insufficient staff for emergency care and of any capacity building efforts. To achieve the goals of Sustainable Development Goal Number 3 (SDG-3) and realise the government's vision of universal healthcare for all, alternatives to the human resource challenge are key. Modifying the Scope of Practice of Kenyan nurses is one possible solution. Task-shifting traditionally cardiologist roles such as focused cardiac ultrasound (FoCUS) could shorten the time it takes to make a diagnosis in patients with cardiorespiratory failure of likely cardiac origin, making prolonged turnaround times in our public facilities a thing of the past. Our overarching aim is to harness the power of nurses doing FoCUS. The central hypothesis of this work is that in patients with cardiorespiratory failure, a nurse-led FoCUS-guided service would shorten time to diagnosis, supporting interventions and improving outcomes among the critically ill. Insight into potential barriers and enablers for the implementation of a nurse-performed FoCUS service in Kenya is crucial for the success of such a service redesign.

Enrollment: 732 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Any one of:

• Systolic blood pressure <90 millimetres of mercury (mmHg)
• Mean arterial pressure (MAP)<65 millimetres of mercury (mmHg)
• Shock index >1 (heart rate/systolic blood pressure)
• Respiratory rate > 30 breaths/minute
• Oxygen saturations <94%
• Arterial oxygen partial pressure (paO2) <60 millimetres of mercury (mmHg)
• Arterial carbon dioxide partial pressure (paCO2) >50 millimetres of mercury(mmHg)

Exclusion criteria

• Trauma
• Pregnancy
• Patients requiring immediate life-saving interventions eg cardiopulmonary resuscitation (CPR) or defibrillation

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

732 participants in 2 patient groups

Usual care

Active Comparator group

Description:

The control arm will consist of usual care ie a combination of physical examination, lab tests and imaging. The need for a formal echocardiographic evaluation by a cardiologist or cardiac sonographer in patients assigned to the control arm will be at the discretion of the clinical teams, as is usual care at the Kenyatta National Hospital (KNH) and Aga Khan University Hospital Nairobi (AKUHN). A diagnosis will be selected based on the same pre-defined checklist and the time the diagnosis is made recorded.

Treatment:

Other: Usual care

Nurse-performed focused cardiac ultrasound (FoCUS)

Experimental group

Description:

The experimental arm will consist of nurse-performed FoCUS for patients with cardiorespiratory failure. A FoCUS-trained nurse will perform a FoCUS examination within 30 minutes of triage by the triage clinician. The Philips Lumify® handheld ultrasound device (HUD) with a phased array probe will be used and studies limited to a maximum of 10 minutes each. A presumptive diagnosis will then be selected by the nurse from a FoCUS checklist based on pre-defined thresholds for each FoCUS target condition and the time the diagnosis is made recorded. Additional imaging and lab tests may be requested at the discretion of the clinical team but the FoCUS nurses will be blinded to the results of these.

Treatment:

Device: Nurse-performed Focused cardiac ultrasound (FoCUS)