Critical IllnessNCT07917988
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
An observational study of Critical Illness and Ultrasound, run by Hospital General Universitario de Castellón at 1 site in Belgium.
Trial summary
This study using a Delphi methodology, and involving international experts, will help define a training curriculum for core competencies for general intensive care ultrasound practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, Ultrasound, POCUS
- What is being tested?
- Delphi procedure
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Nov 2026to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A diverse (geography, sex, country income) group of physicians meeting all of the inclusion criteria.
Who may be able to join
None listed.
Who cannot join
- Inability to complete Delphi rounds in English.
- Declared conflict of interest judged to be incompatible with participation.
- Failure to participate in the first Delphi round.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
ESICM
Brussels
Margauz Osselaer, +32 2 559 03 50, education@esicm.org
About this study
Official title: Update of Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Consensus From the European Society of Intensive Care Medicine (ESICM)
This study using a Delphi methodology, and involving international experts, will help define a training curriculum for core competencies for general intensive care ultrasound practice.
Read the detailed description
Intensive care ultrasound has become an integral component of modern intensive care practice. The previous ESICM Delphi consensus on core competencies in intensive care ultrasound was published in 2020. Since then, clinical practice, training standards and programs, technology, and the scope of ultrasound use in intensive care medicine have evolved substantially.
The ESICM General Intensive Care Ultrasound (GenIUS) Core Faculty therefore proposes to update the previous core competency framework through a structured international Delphi consensus process. The aim is to define which ultrasound competencies should be considered core, rather than ADVANCED, for general intensive care ultrasound practice.
The Delphi process is a well-established methodology to generate consensus on a particular topic using the "collective intelligence" of panel members. After reviewing the previous consensus, the steering committee members drafted the initial competencies and will conduct iterative Delphi rounds to generate consensus among the experts. Steering Committee (SC) members will not participate in the Delphi surveys. The study findings will be reported according to the ACCORD criteria.
The Delphi panel will comprise two participant groups: expert panelists and trainee panelists. Recruitment will aim to include at least 60 panelists overall, of whom at least 10% will be clinicians in training. The panel will be international, multidisciplinary, and balanced regarding geographical region, profession, clinical background, sex, ultrasound expertise, and level of training. Participants will be invited worldwide without country restrictions. To ensure representation of diverse healthcare and resource settings, at least 20% of panelists will be based in low- and middle-income countries (LMICs). Recruitment will also aim for broader representation across world regions. Including both experienced clinicians and clinicians in training is intended to ensure the resulting competency framework reflects the perspectives of both established experts and future users of the GenIUS curriculum.
Steps of the Delphi process
Step 1: Establishing a preliminary list of competencies. A focused literature review will be performed by the members of the SC and, based on their input, the steering committee will identify competencies, which will be used to draft Round One of the Delphi process. Prior to Round 1, the Delphi questionnaire will be pilot-tested with a small group of members from the SC.
Step 2: Preparation of the Delphi Round One Survey. The list of competencies will be sent to the Experts as a Delphi questionnaire. The anonymity of the Experts will be maintained until the end of the Delphi rounds. The Experts will be requested to answer questions related to the training curriculum based on their experience and knowledge of the subject. Questions will be based on a 5-point Likert scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). Experts can also provide opinions on additions, deletions, or changes to questions or choices through free text. The responses of experts will be collated during the analysis of results and shared in the following survey as controlled feedback.
Step 3: Subsequent Delphi Rounds. The steering committee will review the results of round one. The competencies listed will be modified, deleted, or added if found ambiguous based on the feedback and comments on the results. The remaining statements will continue in subsequent rounds until response stability is achieved. The cumulative results of round two will be presented to experts along with anonymized comments, and the survey process will be repeated with the modified questionnaire. The Delphi rounds will be continued until the desired consensus and stability are achieved for statements.
Step 4: Final Consensus. Only the competencies that achieved consensus and stability will be used to develop consensus statements. The results of the final survey, consensus statements, and the manuscript will be circulated among the experts for approval before submission for publication.
Statistics Consensus definitions
- Consensus for inclusion: >=80% of panelists score the item 4-5 (strong consensus >=90% of them or median of 5 [interquartile range, IQR 0 or 1]).
- Consensus for exclusion: >80% of panelists score the item 1-2 (strong consensus >=90% of them or median of 1 [IQR 0 or 1]).
- No consensus: failure to meet either threshold after the final Delphi round or when stable non-consensus is reached.
Stability assessment Starting from Round 2, stability will be assessed between two consecutive rounds. An item will be considered stable if there is no statistically significant change in the distribution of responses between consecutive rounds. Wilcoxon signed-rank test will be used, with p ≥ 0.05 indicating significant variation and therefore instability
Statistical reporting For each competency and each round, the methodologist should report the number of respondents, response rate, median, interquartile range, percentage agreement for inclusion, percentage agreement for exclusion, consensus status, stability status, and final classification. Continuous variables will be summarized using the median and IQR. Analysis should be performed using validated statistical software such as R.
- Conditions
- Critical Illness, Ultrasound, POCUS, Training
- Being tested
- Delphi procedure
- Keywords
- Ultrasound, Training, Intensive Care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi procedureOther
The study uses a Delphi process to generate consensus statements from experts and trainees on the training requirements for physicians using ultrasound in critically ill patients.
| Study group | Role | What they receive |
|---|---|---|
| Experts | The expert panelists meeting the eligibility criteria. The Delphi process will be conducted with the recruited panelists. Receives: Other: Delphi procedure | |
| Trainees | The clinicians in training meeting the eligibility criteria. The Delphi process will be conducted with the recruited panelists. Receives: Other: Delphi procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus statements
Consensus amongst the panel regarding training requirements for physicians using ultrasound in critically ill patients will be achieved using Delphi method which includes iterative rounds of questions.
Consensus will be considered reached when a statement achieves >=80% of votes for multiple-choice questions and likert-scale statements.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start16 Nov 2026 (estimated)
- Primary completion10 Jan 2027 (estimated)
- Study completion31 Jan 2027 (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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Castellón
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Laura Galarza, Hospital General Universitario de Castellón
- Investigators
- Laura Galarza, Principal investigator, Hospital Universitari General de Castellón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917988
- Sponsor's protocol ID
- ESICM01
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is available to the contact person to preserve panelist identities and avoid a breach of anonymity.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Update of Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Consensus From the European Society of Intensive Care Medicine (ESICM)
- ClinicalTrials.gov ID
- NCT07917988
- Acronym / sponsor ID
- ESICM01
- Conditions
- Critical Illness, Ultrasound, POCUS, Training
- Keywords
- Ultrasound, Training, Intensive Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital General Universitario de CastellónUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine, Charite University, Berlin, Germany
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Nov 2026 (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.
This study using a Delphi methodology, and involving international experts, will help define a training curriculum for core competencies for general intensive care ultrasound practice.
Detailed description
Intensive care ultrasound has become an integral component of modern intensive care practice. The previous ESICM Delphi consensus on core competencies in intensive care ultrasound was published in 2020. Since then, clinical practice, training standards and programs, technology, and the scope of ultrasound use in intensive care medicine have evolved substantially.
The ESICM General Intensive Care Ultrasound (GenIUS) Core Faculty therefore proposes to update the previous core competency framework through a structured international Delphi consensus process. The aim is to define which ultrasound competencies should be considered core, rather than ADVANCED, for general intensive care ultrasound practice.
The Delphi process is a well-established methodology to generate consensus on a particular topic using the "collective intelligence" of panel members. After reviewing the previous consensus, the steering committee members drafted the initial competencies and will conduct iterative Delphi rounds to generate consensus among the experts. Steering Committee (SC) members will not participate in the Delphi surveys. The study findings will be reported according to the ACCORD criteria.
The Delphi panel will comprise two participant groups: expert panelists and trainee panelists. Recruitment will aim to include at least 60 panelists overall, of whom at least 10% will be clinicians in training. The panel will be international, multidisciplinary, and balanced regarding geographical region, profession, clinical background, sex, ultrasound expertise, and level of training. Participants will be invited worldwide without country restrictions. To ensure representation of diverse healthcare and resource settings, at least 20% of panelists will be based in low- and middle-income countries (LMICs). Recruitment will also aim for broader representation across world regions. Including both experienced clinicians and clinicians in training is intended to ensure the resulting competency framework reflects the perspectives of both established experts and future users of the GenIUS curriculum.
Steps of the Delphi process
Step 1: Establishing a preliminary list of competencies. A focused literature review will be performed by the members of the SC and, based on their input, the steering committee will identify competencies, which will be used to draft Round One of the Delphi process. Prior to Round 1, the Delphi questionnaire will be pilot-tested with a small group of members from the SC.
Step 2: Preparation of the Delphi Round One Survey. The list of competencies will be sent to the Experts as a Delphi questionnaire. The anonymity of the Experts will be maintained until the end of the Delphi rounds. The Experts will be requested to answer questions related to the training curriculum based on their experience and knowledge of the subject. Questions will be based on a 5-point Likert scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). Experts can also provide opinions on additions, deletions, or changes to questions or choices through free text. The responses of experts will be collated during the analysis of results and shared in the following survey as controlled feedback.
Step 3: Subsequent Delphi Rounds. The steering committee will review the results of round one. The competencies listed will be modified, deleted, or added if found ambiguous based on the feedback and comments on the results. The remaining statements will continue in subsequent rounds until response stability is achieved. The cumulative results of round two will be presented to experts along with anonymized comments, and the survey process will be repeated with the modified questionnaire. The Delphi rounds will be continued until the desired consensus and stability are achieved for statements.
Step 4: Final Consensus. Only the competencies that achieved consensus and stability will be used to develop consensus statements. The results of the final survey, consensus statements, and the manuscript will be circulated among the experts for approval before submission for publication.
Statistics Consensus definitions
- Consensus for inclusion: >=80% of panelists score the item 4-5 (strong consensus >=90% of them or median of 5 [interquartile range, IQR 0 or 1]).
- Consensus for exclusion: >80% of panelists score the item 1-2 (strong consensus >=90% of them or median of 1 [IQR 0 or 1]).
- No consensus: failure to meet either threshold after the final Delphi round or when stable non-consensus is reached.
Stability assessment Starting from Round 2, stability will be assessed between two consecutive rounds. An item will be considered stable if there is no statistically significant change in the distribution of responses between consecutive rounds. Wilcoxon signed-rank test will be used, with p ≥ 0.05 indicating significant variation and therefore instability
Statistical reporting For each competency and each round, the methodologist should report the number of respondents, response rate, median, interquartile range, percentage agreement for inclusion, percentage agreement for exclusion, consensus status, stability status, and final classification. Continuous variables will be summarized using the median and IQR. Analysis should be performed using validated statistical software such as R.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experts | – | Other: Delphi procedureThe expert panelists meeting the eligibility criteria. The Delphi process will be conducted with the recruited panelists. |
| Trainees | – | Other: Delphi procedureThe clinicians in training meeting the eligibility criteria. The Delphi process will be conducted with the recruited panelists. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A diverse (geography, sex, country income) group of physicians meeting all of the inclusion criteria.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Inability to complete Delphi rounds in English.
- Declared conflict of interest judged to be incompatible with participation.
- Failure to participate in the first Delphi round.
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 |
|---|---|---|
| Delphi procedureThe study uses a Delphi process to generate consensus statements from experts and trainees on the training requirements for physicians using ultrasound in critically ill patients. | Other | Experts, Trainees |
Primary outcome
Consensus statements
Time frame: Through study completion, an average of 3 months
Consensus amongst the panel regarding training requirements for physicians using ultrasound in critically ill patients will be achieved using Delphi method which includes iterative rounds of questions. Consensus will be considered reached when a statement achieves >=80% of votes for multiple-choice questions and likert-scale statements.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. IPD is available to the contact person to preserve panelist identities and avoid a breach of anonymity.
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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.
Laura Galarza principal investigator
Hospital Universitari General de Castellón
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Ultrasound, run by Hospital General Universitario de Castellón at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. 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: opening soon, as of the sponsor's last update on 5 Nov 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Galarza, PhD ((34)964725000, galarza_lau@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus statements (time frame: Through study completion, an average of 3 months). 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 5 Nov 2026.