Cardiorespiratory FailureHARAKA-2NCT04344418
Harnessing Alternative Resources to Aid Kenyans With Acute Illness
A study testing Nurse-performed Focused cardiac ultrasound (FoCUS) in people with Cardiorespiratory Failure, run by Aga Khan University.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiorespiratory Failure
- What is being tested?
- Nurse-performed Focused cardiac ultrasound (FoCUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 732 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Trauma
- Pregnancy
- Patients requiring immediate life-saving interventions eg cardiopulmonary resuscitation (CPR) or defibrillation
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the detailed 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.
- Conditions
- Cardiorespiratory Failure
- Being tested
- Nurse-performed Focused cardiac ultrasound (FoCUS), Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Usual careOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Nurse-performed Focused cardiac ultrasound (FoCUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis
Difference in median time to diagnosis between nurse-performed FoCUS and usual care.
Measured: 24 hours
Secondary outcomes (5)
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
Measured: 10 months
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
Measured: 10 months
Diagnostic accuracy of nurse-performed FoCUS
Sensitivity and specificity of novice FoCUS compared to a reference standard (cardiologist opinion)
Measured: 10 months
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
Measured: 10 months
Proportion of novice scanners able to access remote supervision for FoCUS practice.
Proportion of novice scanners able to access remote supervision for FoCUS practice.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 2-cluster stepped wedge clinical feasibility trial
- Masking
- None (open label)
- Enrolment
- 732 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Kenyatta National Hospital
- Responsible party
- Principal investigator, Dr. Wangari Waweru-Siika, Aga Khan University
- Investigators
- Wangari Waweru-Siika, FRCA, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344418
- Sponsor's protocol ID
- 31-20
- Acronym
- HARAKA-2
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available on request
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04344418
- Acronym / sponsor ID
- HARAKA-2 / 31-20
- Conditions
- Cardiorespiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 732 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- University of Oxford, Kenyatta National Hospital
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-cluster stepped wedge clinical feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual careThe 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. |
| Nurse-performed focused cardiac ultrasound (FoCUS) | Experimental | Device: Nurse-performed Focused cardiac ultrasound (FoCUS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (3 listed)
- Trauma
- Pregnancy
- Patients requiring immediate life-saving interventions eg cardiopulmonary resuscitation (CPR) or defibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Nurse-performed focused cardiac ultrasound (FoCUS) |
| Usual careThe 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 | Other | Usual care |
Primary outcome
Time to diagnosis
Time frame: 24 hours
Difference in median time to diagnosis between nurse-performed FoCUS and usual care.
5 secondary outcomes
Number of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E
Time frame: 10 months
Proportion of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E
Time frame: 10 months
Diagnostic accuracy of nurse-performed FoCUS
Time frame: 10 months
Number of FoCUS protocol components suitable for inclusion in a local FoCUS curriculum
Time frame: 10 months
Proportion of novice scanners able to access remote supervision for FoCUS practice.
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: Yes. Available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wangari Waweru-Siika, FRCA principal investigator
Aga Khan University
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-performed Focused cardiac ultrasound (FoCUS) in people with Cardiorespiratory Failure, run by Aga Khan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wangari Waweru-Siika, FRCA (+254708612258, wangari.waweru-siika@kellogg.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to diagnosis (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.