- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04344418
Harnessing Alternative Resources to Aid Kenyans With Acute Illness (HARAKA-2)
12. april 2020 opdateret af: Dr. Wangari Waweru-Siika, Aga Khan University
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
732
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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 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.
|
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
|
Eksperimentel: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time to diagnosis
Tidsramme: 24 hours
|
Difference in median time to diagnosis between nurse-performed FoCUS and usual care.
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E
Tidsramme: 10 months
|
Number of patients with cardiorespiratory failure who have a FoCUS
|
10 months
|
Proportion of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E
Tidsramme: 10 months
|
Proportion of patients with cardiorespiratory failure who have a FoCUS
|
10 months
|
Diagnostic accuracy of nurse-performed FoCUS
Tidsramme: 10 months
|
Sensitivity and specificity of novice FoCUS compared to a reference standard (cardiologist opinion)
|
10 months
|
Number of FoCUS protocol components suitable for inclusion in a local FoCUS curriculum
Tidsramme: 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.
Tidsramme: 10 months
|
Proportion of novice scanners able to access remote supervision for FoCUS practice.
|
10 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Wangari Waweru-Siika, FRCA, Aga Khan University, Nairobi
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. juni 2020
Primær færdiggørelse (Forventet)
30. april 2021
Studieafslutning (Forventet)
30. april 2021
Datoer for studieregistrering
Først indsendt
7. april 2020
Først indsendt, der opfyldte QC-kriterier
12. april 2020
Først opslået (Faktiske)
14. april 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. april 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. april 2020
Sidst verificeret
1. april 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 31-20
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Available on request
IPD-delingstidsramme
6 months after publication
IPD-delingsadgangskriterier
Available on request
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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