Harnessing Alternative Resources to Aid Kenyans With Acute Illness

Cardiorespiratory Failure Clinical Trial

— HARAKA-2  

Official title:

Impact of Nurse-Led Focused Cardiac Ultrasound Versus Usual Care on Time to Diagnosis in Adults With Cardiorespiratory Failure: A Two-Cluster Stepped Wedge Clinical Feasibility Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04344418
• Other study ID #: 31-20
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2020
• Source: Aga Khan University
• Contact: Wangari Waweru-Siika, FRCA
• Phone: +254708612258
• Email: wangari.waweru-siika[@]kellogg.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 732
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiorespiratory Failure

Intervention

Device:
• Nurse-performed Focused cardiac ultrasound (FoCUS)
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.

Other:
• Usual care
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 KNH and AKUHN

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	Kenyatta National Hospital, University of Oxford

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to diagnosis	Difference in median time to diagnosis between nurse-performed FoCUS and usual care.	24 hours
Secondary	Number of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E	Number of patients with cardiorespiratory failure who have a FoCUS	10 months
Secondary	Proportion of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E	Proportion of patients with cardiorespiratory failure who have a FoCUS	10 months
Secondary	Diagnostic accuracy of nurse-performed FoCUS	Sensitivity and specificity of novice FoCUS compared to a reference standard (cardiologist opinion)	10 months
Secondary	Number of FoCUS protocol components suitable for inclusion in a local FoCUS curriculum	Number of FoCUS protocol components suitable for inclusion in a local FoCUS curriculum	10 months
Secondary	Proportion of novice scanners able to access remote supervision for FoCUS practice.	Proportion of novice scanners able to access remote supervision for FoCUS practice.	10 months