An interventional study of Whole body point of care ultrasound scan in Critical Illness, Cardiac Complication and Pleural Effusion, sponsored by King's College Hospital NHS Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-04.
Sponsored by King's College Hospital NHS Trust · Not applicable, Interventional, and Diagnostic
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.
PoCUS is a non-invasive procedure that does not use harmful radiation. PoCUS therefore minimises patient risk and has superior diagnostic capabilities compared to the stethoscope. Non-medics can learn and utilise PoCUS with comparable accuracy. Routine whole-body PoCUS could enable more informed and timely clinical decision-making regarding lifesaving interventions such as patient positioning (proning), ventilatory support, and fluid balance optimisation. PoCUS could decrease time spent in diagnostic testing outside the ICU, minimising spread of infection through reduced patient contact, and reduce risk associated with patient transfers to scanning. Increased PoCUS use therefore has the potential to positively impact more patients, with less disruption to patient care.
In addition, increased routine PoCUS use by multiple professions will create a shared communication platform with the potential to enhance interdisciplinary collaboration. PoCUS use meets the growing demand for advanced assessment skills in the ICU, increasing autonomy and improving staff retention. PoCUS may reduce service costs by limiting the need for other imaging. In addition, the economic value of fewer diagnostic tests and the potential for improved patient outcomes could be significant. Storage solutions for diagnostic imaging present an ongoing challenge throughout the healthcare service. Imaging is stored on multiple platforms, making reviewing of images often location dependent. Identifying the most accessible storage platform for routine image review could significantly influence utilisation of images during patient assessment.
The investigator's aim is to evaluate the acceptability and feasibility of the INSIGHT Intervention within the ICU environment. This comprises performing a whole body PoCUS (INSIGHT) scan on days 1, 3, and 7 of ICU admission, with review by the clinical team.
The INSIGHT Scan is a whole-body PoCUS scan which comprises imaging the following windows:
Design and Setting: A mixed-methods study across 2 adult ICUs (30 beds) within the critical care centre at KCH, London.
The Study will be conducted in two stages:
Stage 1 Aim: The aim of this stage is to identify and address the acceptability and feasibility of the INSIGHT intervention from the perspective of key stakeholders.
The primary objectives will be to:
The following feasibility outcomes will be evaluated:
ICU Patient Sample: Convenience sampling will be used to recruit 20 adult (18 years or over) ICU patients.
ICU Staff Sample: Prior to stage 1 commencement, a minimum of 10 staff members will have completed the training and will be approached for consent to participate in this study.
Fifteen INSIGHT-trained and non INSIGHT-trained clinical staff will be recruited using purposive sampling (ACCPs, nurses, doctors, physiotherapists) to either attend one of two focus groups.
Data collection methods:
Stage 2 Aim: To evaluate the feasibility of the INSIGHT intervention trial design to inform a future adequately powered randomised controlled trial.
Primary Objective: To evaluate the feasibility of a randomised controlled trial of the INSIGHT Scanning Protocol.
Feasibility objectives:
Exploratory clinical objectives:
Patient participant sample: The investigators will recruit 60 patients during the study.
Randomisation: Participants will be randomised to receive the INSIGHT intervention or standard care (no INSIGHT intervention) on a 1:1 basis.
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 142 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →King's College Hospital NHS Trust is the lead sponsor of 171 studies on the registry; 56 are open to participants now.
Compared within Pleural Effusion, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Injuries that prevent probe positioning:
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
Thirty patients will receive standard care (regular ICU treatment without any restriction to usual medical care). INSIGHT scans will not be performed on these patients. However, other forms of ultrasound scanning will be permitted in this group. For example, departmental ultrasound scans (full echocardiography, liver, or vascular ultrasound assessment); transoesophageal echocardiography; transcranial doppler; any form of PoCUS other than the INSIGHT scan.
Thirty patients will receive standard care + the INSIGHT intervention. The INSIGHT intervention is described in detail in section 5.7.1. INSIGHT scans will be performed by staff trained in the INSIGHT Training and Competency Programme on days 1 (0-36 hours), 3 (72-96 hours) and 7 (6 to 8 days) from ICU admission. Scans will only be performed at these timepoints if the patient is still admitted to the ICU.
Diagnostic Test: Whole body point of care ultrasound scan
The INSIGHT Scan is a whole-body PoCUS scan which comprises imaging the following windows: 1. subcostal 2. inferior vena cava cardiac view 3. left hemidiaphragm 4. bladder 5. right hemidiaphragm 6. six major central veins (left/right internal jugular/ subclavian/ femoral veins) The scan should take no more than 10 minutes to perform. Simple yes/no questions are asked for each window to identify any significant abnormalities. For example, is the left ventricle bigger than the right ventricle; is there a pleural effusion; is the bladder distended etc. The scan is reported in the intensive care online medical notes and reviewed by the clinical team as soon as possible.
Also known as: The INSIGHT scan
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.
Time frame: Day of ICU admission (day 1) to day 7 of ICU admission
Recruitment rate and willingness of approached eligible patients to consent
We will capture those who do not consent in a screening log
Time frame: Through to study completion, approximately 18 months
Number of complete scans (i.e., 6/6 windows)
The proportion of ultrasound scans that are completed
Time frame: Through to study completion, approximately 18 months
Reasons scans not performed/completed
We will capture reasons for not completing scan in the ultrasound report
Time frame: Through to study completion, approximately 18 months
Proportion of complete scan reports compared to the total number of scans performed
Time frame: Through to study completion, approximately 18 months
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
Time frame: 18 months
Rate of adverse and serious adverse events
Time frame: Through to study completion, approximately 18 months
Number of diagnostic tests (chest X-ray, non-INSIGHT ultrasound, CT scans [excluding head]) per patient during ICU stay
Time frame: Day of ICU admission to day 28 or ICU discharge/death
Radiation exposure
measured in millisievert
Time frame: Day of ICU admission to day 28 or ICU discharge/death
Duration of mechanical ventilation
Multiple episodes will be recorded if patient is reintubated
Time frame: Day of ICU admission to day 28 or ICU discharge/death
ICU length of stay
Time frame: Day of ICU admission to day 28 or ICU discharge/death
Number and type of nosocomial infections
site of infection, organism confirmed by microbiology, antibiotic treatment, date started, date stopped will all be collected
Time frame: Day of ICU admission to day 28 or ICU discharge/death
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
Time frame: Day of ICU admission (day 1), day 3, and day 7 of ICU admission
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)
Time frame: Day of ICU admission to day 28 or ICU discharge/death
Plan to share: No — The data collected will only be used for publications relating to this trial. Relevant data to the publications will be published. More detailed datasets will be available on request. However these data cannot be used for any other research.
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