Critical Illness Clinical Trial
— INSIGHTOfficial title:
Acceptability and Feasibility of Interprofessional Scheduled Whole-Body Point-of-Care Ultrasound in the Intensive Care Unit: A Randomised Controlled Feasibility Trial
Point-of-care ultrasound (PoCUS) is a rapidly evolving method of clinical assessment within the intensive care unit (ICU) with training predominantly aimed at physicians. Routine whole-body PoCUS (lungs, heart, abdomen and blood vessels) when conducted by physicians benefits patient care and outcomes including reducing the risk of prolonged ICU stay (>7 days) and mechanical ventilation as well as reducing utilisation of other diagnostic tests. However, physician-only use of PoCUS does not allow for use as a routine assessment method in the ICU due to the low physician to patient ratio and poor ultrasound accreditation rate. Providing other healthcare professionals such as Advanced Critical Care Practitioners (ACCPs), ICU nurses and physiotherapists with PoCUS skills increases the proportion of trained staff to perform routine PoCUS in the ICU. This could aid earlier identification of abnormal pathology, earlier treatment, and prevent patient deterioration. The advancement of handheld PoCUS technology is making ultrasound more portable, cheaper and easier to use. The increased accessibility of PoCUS combined with growing evidence of its diagnostic accuracy compared to other modes of imaging means PoCUS use is gaining traction globally. However, little to no research exists investigating the feasibility of implementing scheduled interprofessional PoCUS in the ICU and its impact on patient outcomes. This study aims to evaluate the acceptability and feasibility of a quick and simple whole body ultrasound scan performed by trained ACCPs, ICU nurses, physiotherapists, and doctors at set time points throughout the patients ICU stay. The investigators want to find out the most common barriers and facilitators to intervention implementation and to explore the key clinical outcomes for use in a future definitive RCT.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Patient Inclusion Criteria: 1. Patients 18 years of age or more 2. Critically ill patient requiring level 2/3 care 3. Provides consent to participate (or consent given by substitute decision maker) 4. Anticipated to be admitted to ICU for at least 72 hours from time of admission Patient Exclusion Criteria: 1. Injuries that prevent probe positioning: 1. Dressings that restrict the INSIGHT window views 2. Flail chest 3. Other unstable fractures that might prevent scanning 4. Open abdominal/thorax wounds 5. Surgical emphysema 2. Uncontrolled agitation or pain: this will make scanning more challenging and affect image acquisition 3. Clinical instability requiring prioritisation of stabilising or resuscitative care 4. Allergy to ultrasound gel 5. Anticipated withdrawal of care in the next 24 hours Staff Inclusion Criteria i. Nurse, ACCP, physiotherapist, or doctor ii. Completion of an advanced course in ICU nursing, ACCP course, ICU physiotherapy or medicine iii. Working in a participating ICU for a minimum of 6 months before enrolment on training course iv. Competent or undergoing training in the INSIGHT Scan ICU staff exclusion criteria i. Any injuries or musculoskeletal conditions that would be exacerbated by performing ultrasound ii. On rotation or planning on leaving ICU role in 6 or less months |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust | King's College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of diagnostic tests (chest X-ray, non-INSIGHT ultrasound, CT scans [excluding head]) per patient during ICU stay | Day of ICU admission to day 28 or ICU discharge/death | ||
Other | Radiation exposure | measured in millisievert | Day of ICU admission to day 28 or ICU discharge/death | |
Other | Duration of mechanical ventilation | Multiple episodes will be recorded if patient is reintubated | Day of ICU admission to day 28 or ICU discharge/death | |
Other | ICU length of stay | Day of ICU admission to day 28 or ICU discharge/death | ||
Other | Number and type of nosocomial infections | site of infection, organism confirmed by microbiology, antibiotic treatment, date started, date stopped will all be collected | Day of ICU admission to day 28 or ICU discharge/death | |
Other | Number and type of incidental clinical findings detected using the INSIGHT scan | Findings include: Pericardial effusion; Dilated right ventricle; Abnormal contractility and function of the left or right ventricle; Lung consolidation; Pleural effusion; Presence of 3 or more B-lines; Abdominal fluid collection; Abnormal growth/ thrombus in any view | Day of ICU admission (day 1), day 3, and day 7 of ICU admission | |
Other | Time from ICU admission (or from INSIGHT scan if performed on days 3 and 7) to clinical | Interventions include: Insertion of central venous catheter; Commencement of first vasopressors whilst in ICU; Renal filtration; Start of first antibiotics prescribed in ICU; Drain inserted (specify type); ECG; Insertion of urinary catheter; Repositioning of existing urinary catheter; Other (please specify) | Day of ICU admission to day 28 or ICU discharge/death | |
Primary | Adherence to the INSIGHT Scanning Protocol, measured by the number of INSIGHT scan reports completed compared to the number required in the INSIGHT protocol design | Scanning timepoints are on days 1, 3, and 7 of ICU admission. However the patient may have been discharged before the second or third timepoint. This measure therefore captures feasibility of performing the scan during the available opportunities only. | Day of ICU admission (day 1) to day 7 of ICU admission | |
Primary | Recruitment rate and willingness of approached eligible patients to consent | We will capture those who do not consent in a screening log | Through to study completion, approximately 18 months | |
Primary | Number of complete scans (i.e., 6/6 windows) | The proportion of ultrasound scans that are completed | Through to study completion, approximately 18 months | |
Primary | Reasons scans not performed/completed | We will capture reasons for not completing scan in the ultrasound report | Through to study completion, approximately 18 months | |
Primary | Proportion of complete scan reports compared to the total number of scans performed | Through to study completion, approximately 18 months | ||
Primary | Staff perceived feasibility of the INSIGHT Scan on days 1, 3, and 7 of ICU admission | We will capture this during semi-structured 30 minute interviews | 18 months | |
Primary | Rate of adverse and serious adverse events | Through to study completion, approximately 18 months |
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