Harnessing Alternative Resources to Aid Kenyans With Acute Illness

NCT04344418 | Unknown

• 1 other identifier: 31-20
• Study Type: interventional
• Target: 732
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiorespiratory Failure

Outcome Measures

Primary Outcomes (1)

• Time to diagnosis

  Difference in median time to diagnosis between nurse-performed FoCUS and usual care.

  24 hours

Secondary Outcomes (5)

• Number of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E

  10 months

• Proportion of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E

  10 months

• Diagnostic accuracy of nurse-performed FoCUS

  10 months

• Number of FoCUS protocol components suitable for inclusion in a local FoCUS curriculum

  10 months

• Proportion of novice scanners able to access remote supervision for FoCUS practice.

  10 months

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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.

Other: Usual care

Nurse-performed focused cardiac ultrasound (FoCUS)

EXPERIMENTAL

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.

Device: Nurse-performed Focused cardiac ultrasound (FoCUS)

Interventions

Nurse-performed Focused cardiac ultrasound (FoCUS) DEVICE

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.

Nurse-performed focused cardiac ultrasound (FoCUS)

Usual care OTHER

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

Usual care

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead
• University of Oxford: collaborator
• Kenyatta National Hospital: collaborator

Study Officials

• Wangari Waweru-Siika, FRCA

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wangari Waweru-Siika, FRCA

CONTACT

+254708612258; wangari.waweru-siika@kellogg.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 2-cluster stepped wedge clinical feasibility trial

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 14, 2020
• Study Start: June 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: Available on request