Acceptability and Feasibility of Interprofessional Scheduled Whole-Body Point-of-Care Ultrasound in the Intensive Care Unit: A Randomised Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of complete scans (i.e., 6/6 windows)
研究概览
简要总结
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.
详细描述
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:
- subcostal
- inferior vena cava cardiac view
- left hemidiaphragm
- bladder
- right hemidiaphragm
- six major central veins (left/right internal jugular/ subclavian/ femoral veins)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •Patients 18 years of age or more
- •Critically ill patient requiring level 2/3 care
- •Provides consent to participate (or consent given by substitute decision maker)
- •Anticipated to be admitted to ICU for at least 72 hours from time of admission
排除标准
- •Injuries that prevent probe positioning:
- •Dressings that restrict the INSIGHT window views
- •Flail chest
- •Other unstable fractures that might prevent scanning
- •Open abdominal/thorax wounds
- •Surgical emphysema
- •Uncontrolled agitation or pain: this will make scanning more challenging and affect image acquisition
- •Clinical instability requiring prioritisation of stabilising or resuscitative care
- •Allergy to ultrasound gel
- •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
结局指标
主要结局
Number of complete scans (i.e., 6/6 windows)
时间窗: Through to study completion, approximately 18 months
The proportion of ultrasound scans that are completed
Proportion of complete scan reports compared to the total number of scans performed
时间窗: Through to study completion, approximately 18 months
Rate of adverse and serious adverse events
时间窗: Through to study completion, approximately 18 months
Staff perceived feasibility of the INSIGHT Scan on days 1, 3, and 7 of ICU admission
时间窗: 18 months
We will capture this during semi-structured 30 minute interviews
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
时间窗: Day of ICU admission (day 1) to day 7 of ICU admission
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.
Reasons scans not performed/completed
时间窗: Through to study completion, approximately 18 months
We will capture reasons for not completing scan in the ultrasound report
Recruitment rate and willingness of approached eligible patients to consent
时间窗: Through to study completion, approximately 18 months
We will capture those who do not consent in a screening log
次要结局
未报告次要终点