Critical IllnessINSIGHTNCT05569798
The INSIGHT Feasibility Study Ultrasound in the Intensive Care Unit: A Randomised Controlled Feasibility Trial
A study testing Whole body point of care ultrasound scan in people with Critical Illness and Cardiac Complication, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Cardiac Complication, Pleural Effusion
- What is being tested?
- Whole body point of care ultrasound scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Dec 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Eleanor Corcoran, 02032991038, e.corcoran@nhs.net
Phil Hopkins, 02032991038 ext. Corcoran, e.corcoran@nhs.net
About this study
Official 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.
Read more
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.
Read the 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
- 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.
- Conditions
- Critical Illness, Cardiac Complication, Pleural Effusion, Consolidation, Ascites, Thrombosis
- Being tested
- Whole body point of care ultrasound scan
- Medical subject headings
- Critical Illness, Pleural Effusion, Ascites, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body point of care ultrasound scanDiagnostic test
Also called The INSIGHT scan
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Whole body point of care ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Through to study completion, approximately 18 months
Number of complete scans (i.e., 6/6 windows)
The proportion of ultrasound scans that are completed
Measured: Through to study completion, approximately 18 months
Reasons scans not performed/completed
We will capture reasons for not completing scan in the ultrasound report
Measured: Through to study completion, approximately 18 months
Proportion of complete scan reports compared to the total number of scans performed
Measured: 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
Measured: 18 months
Rate of adverse and serious adverse events
Measured: Through to study completion, approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start4 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel single centre feasibility randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Eleanor Corcoran, Principal investigator, Doctoral Research Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569798
- Sponsor's protocol ID
- 313425
- Acronym
- INSIGHT
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Interprofessional Scheduled Whole-Body Point-of-Care Ultrasound in the Intensive Care Unit: A Randomised Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT05569798
- Acronym / sponsor ID
- INSIGHT / 313425
- Conditions
- Critical Illness, Cardiac Complication, Pleural Effusion, Consolidation, Ascites, Thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 4 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A parallel single centre feasibility randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Whole body point of care ultrasound scanThirty 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body point of care ultrasound scanAlso: The INSIGHT scanThe 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. | Diagnostic test | Standard care + the INSIGHT intervention |
Primary outcome
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
Time frame: 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.
Recruitment rate and willingness of approached eligible patients to consent
Time frame: Through to study completion, approximately 18 months
We will capture those who do not consent in a screening log
Number of complete scans (i.e., 6/6 windows)
Time frame: Through to study completion, approximately 18 months
The proportion of ultrasound scans that are completed
Reasons scans not performed/completed
Time frame: Through to study completion, approximately 18 months
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
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
Time frame: 18 months
We will capture this during semi-structured 30 minute interviews
Rate of adverse and serious adverse events
Time frame: Through to study completion, approximately 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor Corcoran principal investigator
Doctoral Research Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body point of care ultrasound scan in people with Critical Illness and Cardiac Complication, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleanor Corcoran (02032991038 ext. 31038, e.corcoran@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day of ICU admission (day 1) to day 7 of ICU admission). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.