- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04344418
Harnessing Alternative Resources to Aid Kenyans With Acute Illness (HARAKA-2)
12. April 2020 aktualisiert von: 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.
Studienübersicht
Status
Unbekannt
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
732
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time to diagnosis
Zeitfenster: 24 hours
|
Difference in median time to diagnosis between nurse-performed FoCUS and usual care.
|
24 hours
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E
Zeitfenster: 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
Zeitfenster: 10 months
|
Proportion of patients with cardiorespiratory failure who have a FoCUS
|
10 months
|
|
Diagnostic accuracy of nurse-performed FoCUS
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 10 months
|
Proportion of novice scanners able to access remote supervision for FoCUS practice.
|
10 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Wangari Waweru-Siika, FRCA, Aga Khan University, Nairobi
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. Juni 2020
Primärer Abschluss (Voraussichtlich)
30. April 2021
Studienabschluss (Voraussichtlich)
30. April 2021
Studienanmeldedaten
Zuerst eingereicht
7. April 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. April 2020
Zuerst gepostet (Tatsächlich)
14. April 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. April 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. April 2020
Zuletzt verifiziert
1. April 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 31-20
Plan für individuelle Teilnehmerdaten (IPD)
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JA
Beschreibung des IPD-Plans
Available on request
IPD-Sharing-Zeitrahmen
6 months after publication
IPD-Sharing-Zugriffskriterien
Available on request
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
- CSR
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Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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