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

Primary Purpose

Critical Illness, Cardiac Complication, Pleural Effusion

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Whole body point of care ultrasound scan
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King's College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

Standard care + the INSIGHT intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Recruitment rate and willingness of approached eligible patients to consent
We will capture those who do not consent in a screening log
Number of complete scans (i.e., 6/6 windows)
The proportion of ultrasound scans that are completed
Reasons scans not performed/completed
We will capture reasons for not completing scan in the ultrasound report
Proportion of complete scan reports compared to the total number of scans performed
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
Rate of adverse and serious adverse events

Secondary Outcome Measures

Full Information

First Posted
September 27, 2022
Last Updated
October 3, 2023
Sponsor
King's College Hospital NHS Trust
Collaborators
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT05569798
Brief Title
The INSIGHT Feasibility Study Ultrasound in the Intensive Care Unit: A Randomised Controlled Feasibility Trial
Acronym
INSIGHT
Official Title
Acceptability and Feasibility of Interprofessional Scheduled Whole-Body Point-of-Care Ultrasound in the Intensive Care Unit: A Randomised Controlled Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 4, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
Collaborators
King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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) 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: Assess barriers and facilitators to delivering the delivering the INSIGHT intervention Refine the INSIGHT intervention so that it is acceptable to key stakeholders To have a clear understanding of intervention fidelity and ability to recruit participants (33, 34) The following feasibility outcomes will be evaluated: availability of a trained staff member to perform the INSIGHT scan when an eligible patient is identified barriers to completing the INSIGHT scan barriers to accessing INSIGHT scan images during ward round barriers to incorporating the INSIGHT scan into routine clinical care number of eligible patients (screening data) screening and recruitment methods (number of 'missed' patients and reason for non-enrolment) 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: Go-along interviews with trained staff whilst performing the INSIGHT scan Ward round observations Questionnaires will be distributed to staff before any patients receive an INSIGHT scan, the after 5, 10, 15, and 20 patients have been scanned Focus groups 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: Recruitment rate and willingness of approached eligible patients to consent Number of complete scans (i.e., 6/6 windows) Reasons scans not performed/completed Time taken to perform and report INSIGHT scans Proportion of complete scan reports compared to the total number of scans performed Staff perceived feasibility of the INSIGHT Scan on days 1, 3, and 7 of ICU admission 6. Adherence to the INSIGHT Scanning Protocol, measured by the number of INSIGHT scans and reports completed compared to the number required in the INSIGHT protocol design 7. Rate of adverse and serious adverse events Exploratory clinical objectives: Number of diagnostic tests (chest X-ray, non-INSIGHT ultrasound, CT scans [excluding head]) per patient during ICU stay Radiation exposure (measured in mSv) Duration of mechanical ventilation ICU length of stay Number of nosocomial infections Number and type of incidental clinical findings detected using the INSIGHT scan and time to a clinical intervention to address this incidental clinical finding 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Cardiac Complication, Pleural Effusion, Consolidation, Ascites, Thrombosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A parallel single centre feasibility randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Standard care + the INSIGHT intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Whole body point of care ultrasound scan
Other Intervention Name(s)
The INSIGHT scan
Intervention Description
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) 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.
Primary Outcome Measure Information:
Title
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
Description
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
Title
Recruitment rate and willingness of approached eligible patients to consent
Description
We will capture those who do not consent in a screening log
Time Frame
Through to study completion, approximately 18 months
Title
Number of complete scans (i.e., 6/6 windows)
Description
The proportion of ultrasound scans that are completed
Time Frame
Through to study completion, approximately 18 months
Title
Reasons scans not performed/completed
Description
We will capture reasons for not completing scan in the ultrasound report
Time Frame
Through to study completion, approximately 18 months
Title
Proportion of complete scan reports compared to the total number of scans performed
Time Frame
Through to study completion, approximately 18 months
Title
Staff perceived feasibility of the INSIGHT Scan on days 1, 3, and 7 of ICU admission
Description
We will capture this during semi-structured 30 minute interviews
Time Frame
18 months
Title
Rate of adverse and serious adverse events
Time Frame
Through to study completion, approximately 18 months
Other Pre-specified Outcome Measures:
Title
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
Title
Radiation exposure
Description
measured in millisievert
Time Frame
Day of ICU admission to day 28 or ICU discharge/death
Title
Duration of mechanical ventilation
Description
Multiple episodes will be recorded if patient is reintubated
Time Frame
Day of ICU admission to day 28 or ICU discharge/death
Title
ICU length of stay
Time Frame
Day of ICU admission to day 28 or ICU discharge/death
Title
Number and type of nosocomial infections
Description
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
Title
Number and type of incidental clinical findings detected using the INSIGHT scan
Description
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
Title
Time from ICU admission (or from INSIGHT scan if performed on days 3 and 7) to clinical
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Patient Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eleanor Corcoran
Phone
02032991038
Ext
31038
Email
e.corcoran@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Phil Hopkins
Phone
02032991038
Ext
31038
Email
p.hopkins@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleanor Corcoran
Organizational Affiliation
Doctoral Research Fellow
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleanor Corcoran
Phone
02032991038
Email
e.corcoran@nhs.net
First Name & Middle Initial & Last Name & Degree
Phil Hopkins
Phone
02032991038
Ext
Corcoran
Email
e.corcoran@nhs.net
First Name & Middle Initial & Last Name & Degree
Eleanor Corcoran

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

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

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