The INSIGHT Feasibility Study Ultrasound in the Intensive Care Unit: A Randomised Controlled Feasibility Trial

NCT05569798 | Unknown

• 1 other identifier: 313425
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Cardiac Complication; Pleural Effusion; Consolidation; Ascites; Thrombosis

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• Number of complete scans (i.e., 6/6 windows)

  The proportion of ultrasound scans that are completed

  Through to study completion, approximately 18 months

• Reasons scans not performed/completed

  We will capture reasons for not completing scan in the ultrasound report

  Through to study completion, approximately 18 months

• Proportion of complete scan reports compared to the total number of scans performed

  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

  18 months

• Rate of adverse and serious adverse events

  Through to study completion, approximately 18 months

Other Outcomes (7)

• 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

• Radiation exposure

  Day of ICU admission to day 28 or ICU discharge/death

• Duration of mechanical ventilation

  Day of ICU admission to day 28 or ICU discharge/death

Study Arms (2)

Standard care

NO INTERVENTION

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.

Standard care + the INSIGHT intervention

EXPERIMENTAL

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

Interventions

Whole body point of care ultrasound scan DIAGNOSTIC_TEST

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

Standard care + the INSIGHT intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Critical Illness; Pleural Effusion; Ascites; Thrombosis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pleural Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eleanor Corcoran

  Doctoral Research Fellow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleanor Corcoran

CONTACT

02032991038; e.corcoran@nhs.net

Phil Hopkins

CONTACT

02032991038; p.hopkins@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A parallel single centre feasibility randomised controlled trial

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 6, 2022
• Study Start: December 4, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)