Critical Ill PatientsROTATE-ICUNCT07764562
Development and Validation of an Ultrasound-Based Difficult Cannulation Risk Score
An observational study of Critical Ill Patients and Central Venous Catheter, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Ultrasound-guided internal jugular vein (IJV) catheterization is widely used in critically ill patients. Despite ultrasound guidance, difficult catheterization and first-pass failure remain clinically important and may increase the risk of mechanical complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Ill Patients, Central Venous Catheter
- What is being tested?
- IJV Catheterization
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2026to 2 Sep 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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
Study population: Critically ill adults requiring ultrasound-guided IJV CVC
Who may be able to join
- Age ≥18 years
- Admission to the intensive care unit.
- Clinical indication for central venous catheterization
- Planned internal jugular vein access
- Planned ultrasound-guided catheterization
- Written informed consent obtained from the participant or legally authorized representative, where required
Who cannot join
- Active cardiopulmonary resuscitation at the time of catheterization
- Neck anatomical abnormality preventing standard IJV assessment or catheterization
- Neck hematoma
- Active local soft-tissue infection at the proposed access site
- Planned vascular access through a site other than the internal jugular vein
- Planned catheterization without ultrasound guidance
- Refusal or inability to obtain required informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya training and research hospital health sciences university
Antalya, 07059
About this study
Official title: Development and Validation of an Ultrasound-Based Difficult Cannulation Risk Score for Pre-procedural Internal Jugular Vein Catheterization in Critically Ill Patients: A Prospective Observational Cohort Study
Ultrasound-guided internal jugular vein (IJV) catheterization is widely used in critically ill patients. Despite ultrasound guidance, difficult catheterization and first-pass failure remain clinically important and may increase the risk of mechanical complications. Pre-procedural characteristics of the IJV, its anatomical relationship with the common carotid artery (CCA), head rotation, and operator experience may influence procedural success.
The ROTATE-ICU study is a prospective observational cohort study designed to investigate pre-procedural ultrasound and clinical predictors of difficult IJV catheterization in critically ill adults. Consecutive adult intensive care unit patients undergoing ultrasound-guided IJV central venous catheterization will undergo standardized pre-procedural ultrasound assessment. IJV anterior-posterior diameter, skin-to-vessel depth, IJV position relative to the CCA, head rotation angle, operator experience, and relevant clinical and procedural characteristics will be recorded.
The primary objective is to develop and internally validate a clinical prediction model for cannulation difficulty and first-pass cannulation outcome. Secondary objectives include evaluating the relationship between head rotation and IJV morphology and describing the association between complete IJV collapse and procedural outcomes. The planned enrollment is 150 participants.
Read the detailed description
Central venous catheterization is a common procedure in critically ill patients. Ultrasound guidance improves procedural safety; however, first-pass failure and difficult catheterization remain common and may lead to repeated punctures, prolonged procedure time, arterial puncture, hematoma, and other mechanical complications.
Anatomical characteristics of the internal jugular vein (IJV), particularly vessel diameter and its positional relationship with the common carotid artery (CCA), may influence cannulation difficulty. Operator experience and head position may also modify procedural success. Nevertheless, these factors have rarely been integrated into a prospective pre-procedural prediction strategy in critically ill patients.
ROTATE-ICU is a prospective, single-center observational cohort study enrolling consecutive adult intensive care unit patients undergoing ultrasound-guided IJV central venous catheterization. Before catheterization, patients will undergo standardized ultrasound examination with measurement of the IJV anterior-posterior diameter and skin-to-vessel depth and classification of the IJV position relative to the CCA. Head rotation angle and operator experience will also be recorded.
Procedural outcomes including first-pass cannulation success, number of skin punctures, procedure duration, need for site change, and mechanical complications will be prospectively documented. Difficult catheterization will be defined using a composite of multiple punctures, prolonged procedure duration, and/or need for access-site change.
The study aims to determine independent pre-procedural predictors of cannulation outcome and to develop a clinically applicable ultrasound-based risk prediction model. Model discrimination and calibration will be assessed and internal validation will be performed.
A planned cohort of 150 participants will be enrolled. No intervention is assigned by the study protocol, and all catheterization decisions and clinical management will remain at the discretion of the treating clinical team.
- Conditions
- Critical Ill Patients, Central Venous Catheter
- Being tested
- IJV Catheterization
- Keywords
- Central venous catheterization, Ultrasound guidance, First-pass failure, Critical care, Internal jugular vein, Prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IJV CatheterizationOther
Ultrasound-internal jugular vein central venous catheterization
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill Patients Undergoing IJV Catheterization | Adult intensive care unit patients undergoing clinically indicated ultrasound-internal jugular vein central venous catheterization. Participants will undergo standardized pre-procedural ultrasound assessment and prospective recording of procedural outcomes. No study-specific therapeutic intervention will be assigned. Receives: Other: IJV Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-Pass Internal Jugular Vein Cannulation Success
Successful advancement of the guidewire following the first skin puncture without needle redirection or an additional skin puncture.
Measured: During the catheterization procedure, from initial skin puncture until successful guidewire placement, approximately 30 minutes
Secondary outcomes (6)
Difficult Internal Jugular Vein Catheterization
Difficult catheterization defined as a composite outcome of three or more skin punctures, procedure duration longer than 10 minutes, and/or requirement for a change in vascular access site.
Measured: During the catheterization procedure, approximately 30 minutes
Total number of skin punctures required to achieve successful catheterization
Time from initial skin puncture to successful guidewire or catheter placement.
Measured: During the catheterization procedure
Arterial Puncture
Occurrence of inadvertent arterial puncture during the catheterization procedure.
Measured: During catheterization and immediately after the procedure
Hematoma
Development of a procedure-related hematoma greater than 2 cm.
Measured: During catheterization and immediately after the procedure
Catheter Malposition
Catheter tip or catheter position requiring correction or repositioning following insertion.
Measured: Immediately following catheterization
Pneumothorax
Procedure-related pneumothorax detected following catheterization.
Time Frame
Measured: Within 24 hours after catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start25 Jun 2026
- Primary completion1 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Ill PatientsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Antalya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Şule Asri̇, Principal investigator, Antalya Health Sciences UniversityAsri, M.D, Principal investigator, Antalya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764562
- Sponsor's protocol ID
- 2026-250
- Acronym
- ROTATE-ICU
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zawadka M, Czarnik T, Gawda R, Milobedzka M, Trzebicka J, Krolicki T, Owczuk R, Czuczwar M, Bialka S, Gola W, Aszkielowicz A, Latos M, Wludarczyk A, Szczeklik W, Putowski Z. Central venous cannulation in critically ill patients: guidelines of the Polish Society of Anaesthesiology and Intensive Therapy. Anaesthesiol Intensive Ther. 2026 May 21;58(1):84-105. doi: 10.5114/ait/220388.
PubMed 42246225
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Ultrasound-Based Difficult Cannulation Risk Score for Pre-procedural Internal Jugular Vein Catheterization in Critically Ill Patients: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07764562
- Acronym / sponsor ID
- ROTATE-ICU / 2026-250
- Conditions
- Critical Ill Patients, Central Venous Catheter
- Keywords
- Central venous catheterization, Ultrasound guidance, First-pass failure, Critical care, Internal jugular vein, Prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Antalya Health Sciences UniversityUniversity, hospital or other
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 14 Aug 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.
Ultrasound-guided internal jugular vein (IJV) catheterization is widely used in critically ill patients. Despite ultrasound guidance, difficult catheterization and first-pass failure remain clinically important and may increase the risk of mechanical complications. Pre-procedural characteristics of the IJV, its anatomical relationship with the common carotid artery (CCA), head rotation, and operator experience may influence procedural success.
The ROTATE-ICU study is a prospective observational cohort study designed to investigate pre-procedural ultrasound and clinical predictors of difficult IJV catheterization in critically ill adults. Consecutive adult intensive care unit patients undergoing ultrasound-guided IJV central venous catheterization will undergo standardized pre-procedural ultrasound assessment. IJV anterior-posterior diameter, skin-to-vessel depth, IJV position relative to the CCA, head rotation angle, operator experience, and relevant clinical and procedural characteristics will be recorded.
The primary objective is to develop and internally validate a clinical prediction model for cannulation difficulty and first-pass cannulation outcome. Secondary objectives include evaluating the relationship between head rotation and IJV morphology and describing the association between complete IJV collapse and procedural outcomes. The planned enrollment is 150 participants.
Detailed description
Central venous catheterization is a common procedure in critically ill patients. Ultrasound guidance improves procedural safety; however, first-pass failure and difficult catheterization remain common and may lead to repeated punctures, prolonged procedure time, arterial puncture, hematoma, and other mechanical complications.
Anatomical characteristics of the internal jugular vein (IJV), particularly vessel diameter and its positional relationship with the common carotid artery (CCA), may influence cannulation difficulty. Operator experience and head position may also modify procedural success. Nevertheless, these factors have rarely been integrated into a prospective pre-procedural prediction strategy in critically ill patients.
ROTATE-ICU is a prospective, single-center observational cohort study enrolling consecutive adult intensive care unit patients undergoing ultrasound-guided IJV central venous catheterization. Before catheterization, patients will undergo standardized ultrasound examination with measurement of the IJV anterior-posterior diameter and skin-to-vessel depth and classification of the IJV position relative to the CCA. Head rotation angle and operator experience will also be recorded.
Procedural outcomes including first-pass cannulation success, number of skin punctures, procedure duration, need for site change, and mechanical complications will be prospectively documented. Difficult catheterization will be defined using a composite of multiple punctures, prolonged procedure duration, and/or need for access-site change.
The study aims to determine independent pre-procedural predictors of cannulation outcome and to develop a clinically applicable ultrasound-based risk prediction model. Model discrimination and calibration will be assessed and internal validation will be performed.
A planned cohort of 150 participants will be enrolled. No intervention is assigned by the study protocol, and all catheterization decisions and clinical management will remain at the discretion of the treating clinical team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Patients Undergoing IJV Catheterization | – | Other: IJV CatheterizationAdult intensive care unit patients undergoing clinically indicated ultrasound-internal jugular vein central venous catheterization. Participants will undergo standardized pre-procedural ultrasound assessment and prospective recording of procedural outcomes. No study-specific therapeutic intervention will be assigned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adults requiring ultrasound-guided IJV CVC
Key inclusion criteria (6 listed)
- Age ≥18 years
- Admission to the intensive care unit.
- Clinical indication for central venous catheterization
- Planned internal jugular vein access
- Planned ultrasound-guided catheterization
Key exclusion criteria (7 listed)
- Active cardiopulmonary resuscitation at the time of catheterization
- Neck anatomical abnormality preventing standard IJV assessment or catheterization
- Neck hematoma
- Active local soft-tissue infection at the proposed access site
- Planned vascular access through a site other than the internal jugular vein
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 |
|---|---|---|
| IJV CatheterizationUltrasound-internal jugular vein central venous catheterization | Other | Critically Ill Patients Undergoing IJV Catheterization |
Primary outcome
First-Pass Internal Jugular Vein Cannulation Success
Time frame: During the catheterization procedure, from initial skin puncture until successful guidewire placement, approximately 30 minutes
Successful advancement of the guidewire following the first skin puncture without needle redirection or an additional skin puncture.
6 secondary outcomes
Difficult Internal Jugular Vein Catheterization
Time frame: During the catheterization procedure, approximately 30 minutes
Total number of skin punctures required to achieve successful catheterization
Time frame: During the catheterization procedure
Arterial Puncture
Time frame: During catheterization and immediately after the procedure
Hematoma
Time frame: During catheterization and immediately after the procedure
Catheter Malposition
Time frame: Immediately following catheterization
Pneumothorax
Time frame: Within 24 hours after catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 42246225Zawadka M, Czarnik T, Gawda R, Milobedzka M, Trzebicka J, Krolicki T, Owczuk R, Czuczwar M, Bialka S, Gola W, Aszkielowicz A, Latos M, Wludarczyk A, Szczeklik W, Putowski Z. Central venous cannulation in critically ill patients: guidelines of the Polish Society of Anaesthesiology and Intensive Therapy. Anaesthesiol Intensive Ther. 2026 May 21;58(1):84-105. doi: 10.5114/ait/220388.
- Individual participant dataSharing planned: No
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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.
Şule Asri̇ principal investigator
Antalya Health Sciences University
Asri, M.D principal investigator
Antalya Health Sciences University
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 Ill Patients and Central Venous Catheter, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 4 Sep 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-Pass Internal Jugular Vein Cannulation Success (time frame: During the catheterization procedure, from initial skin puncture until successful guidewire placement, approximately 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07764562, which also lists 1 linked publication.
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 Sep 2026.