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Not yet recruitingNCT07917988Updated Nov 5, 2026

Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study

An observational study in Critical Illness, Ultrasound and POCUS, sponsored by Hospital General Universitario de Castellón. Not yet recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Hospital General Universitario de Castellón · Observational

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Sex
All
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Study 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 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.

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Conditions studied

  • Critical Illness
  • Ultrasound
  • POCUS
  • Training

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Keywords

  • Ultrasound
  • Training
  • Intensive Care
03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's planned enrollment of 60 is below the median of 140 across 814 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Hospital General Universitario de Castellón is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A diverse (geography, sex, country income) group of physicians meeting all of the inclusion criteria.

Eligibility criteria

Inclusion criteria for expert panellists (all criteria must apply):

  • Clinicians with expertise in point-of-care ultrasound (or ICU ultrasound), including echocardiography, thoracic or lung ultrasound, abdominal ultrasound, etc., with at least 5 years of clinical experience, of which >50% was in intensive care medicine.
  • Actively using intensive care ultrasound or point-of-care ultrasound in routine clinical practice.
  • Representation from ESICM sections, or nominated from national/regional professional societies related to intensive care medicine or working with recognized ultrasound networks.

Inclusion criteria for trainee panelists (all criteria must apply):

  • Clinicians currently enrolled in a recognized postgraduate training programme which includes intensive care medicine.
  • Actively using point-of-care ultrasound in routine clinical practice.
  • Demonstrated interest in ultrasound education or research by participating in courses or doing research in ultrasound.
  • Completion of a recent POCUS training programme (national or international) within the last 5 years.

Exclusion Criteria:

  • 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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Experts

    The expert panelists meeting the eligibility criteria. The Delphi process will be conducted with the recruited panelists.

    Other: Delphi procedure

  • Trainees

    The clinicians in training meeting the eligibility criteria. The Delphi process will be conducted with the recruited panelists.

    Other: Delphi procedure

Interventions

  • OtherDelphi procedure

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 3 months

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Study locations

1 site
  • ESICM
    Brussels, Belgium
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References and documents

Individual participant data

Plan to share: No — IPD is available to the contact person to preserve panelist identities and avoid a breach of anonymity.

No publications or documents are linked to this record.

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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07917988
Lead sponsor
Hospital General Universitario de Castellón
Collaborators
European Society of Intensive Care Medicine, Charite University, Berlin, Germany
Responsible party
Laura Galarza (MD, PhD, Hospital General Universitario de Castellón) — Principal investigator
First posted
Nov 5, 2026
Start date
Nov 16, 2026 (estimated)
Primary completion
Jan 10, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Laura Galarza, PhD
Contact
galarza_lau@gva.es
(34)964725000
Laura Galarza
principal investigator · Hospital Universitari General de Castellón

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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