CatheterizationNCT05159063
Bedside Ultrasound for Fluid Estimation
An observational study of Catheterization, run by Gaurang Vaidya at 1 site in United States.
Trial summary
The study aims to standardize patient positioning during bedside ultrasound assessment of internal jugular vein (IJV) and correlate the results with invasive hemodynamics obtained immediately after. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Catheterization
- What is being tested?
- Ultrasound imaging
- Type of treatment
- Medical device
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 30 Apr 2022
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive adult patients scheduled to undergo right heart catheterization.
Who may be able to join
- Undergoing right heart catheterization
Who cannot join
- Superior vena cava obstruction or compression
- Severe tricuspid regurgitation
- Mechanically ventilated patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Internal Jugular and Inferior Vena Cava Diameter Variation on Bedside Ultrasound With Invasive Right Heart Catheterization
The study aims to standardize patient positioning during bedside ultrasound assessment of internal jugular vein (IJV) and correlate the results with invasive hemodynamics obtained immediately after. The study hypothesizes that the respiratory variation in the size of IJV, as estimated through ultrasound at bedside, is an accurate estimation of the patient's actual right atrial pressure estimated through right heart catheterization.
- Conditions
- Catheterization
- Being tested
- Ultrasound imaging
- Keywords
- Internal jugular vein, Inferior vena cava, Right heart catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound imagingDevice
Patients scheduled to undergo right heart catheterization (RHC) as their standard of care will be included in the study.
The patient will be positioned supine at 0 degrees with normal restful breathing and patient looking straight up. After the right sternocleidomastoid muscle is identified, internal jugular vein (IJV) will be imaged at the apex of the triangle formed by the sternal and clavicular heads of the muscle. Similarly, the inferior vena cava (IVC) will be imaged at the caudal end of the sternum. The diameters of both the veins will be noted during normal respiration. The patients will then be asked to sniff and collapsibility of the veins will be noted. No pressure will be applied on the neck. The anticipated duration for image acquisition is between 5 to 10 minutes.
The patients will undergo the scheduled RHC within 1 hour as scheduled.
| Study group | Role | What they receive |
|---|---|---|
| Right heart catheterization | Not described Receives: Device: Ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional diameters of the internal jugular vein (IJV)
The respiratory variation percentage will assessed using M-mode of the ultrasound while the patient is breathing normally. The maximum and minimum anteroposterior diameter will be noted using M-mode (in mm).
Measured: 5 minutes
Cross-sectional diameters of the internal jugular vein (IJV)
Diameter variation index will be calculated as: (maximum diameter - minimum diameter)/ body surface area.
Measured: 5 minutes
Sniff collapsibility of IJV
Complete collapse (0cm) of the anteroposterior diameter of IJV on sniff maneuver by the patient, as assessed by M-mode on the ultrasound.
Measured: 10 minutes
Cross-sectional diameters of the inferior vena cava (IVC)
Maximum diameter - noted using M-mode (in mm) of the ultrasound machine.
Measured: 5 minutes
Cross-sectional diameters of the inferior vena cava (IVC)
Respiratory variation - assessed using M-mode of the ultrasound while the patient is breathing normally. This will be calculated as (maximum diameter - minimum diameter)/maximum diameter and expressed as a percentage. The maximum and minimum diameters will be noted using M-mode (in mm).
Measured: 5 minutes
Cross-sectional diameters of the inferior vena cava (IVC)
Sniff collapsibility - Complete collapse (0cm) of the cross sectional diameter of IVC on sniff maneuver by the patient, as assessed by M-mode of the ultrasound.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start1 Jun 2021
- Primary completion30 Mar 2022
- Study completion30 Apr 2022
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 CatheterizationStudies 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
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaurang Vaidya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gaurang Vaidya, University of Kentucky
- Investigators
- Gaurang Vaidya, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159063
- Sponsor's protocol ID
- 67340
- Status last verified
- Jul 2023
- First submitted
- 17 Nov 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Vaidya GN, Kolodziej A, Stoner B, Galaviz JV, Cao X, Heier K, Thompson M, Birks E, Campbell K. Bedside ultrasound of the internal jugular vein to assess fluid status and right ventricular function: The POCUS-JVD study. Am J Emerg Med. 2023 Aug;70:151-156. doi: 10.1016/j.ajem.2023.05.042. Epub 2023 Jun 6.
PubMed 37307660
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Internal Jugular and Inferior Vena Cava Diameter Variation on Bedside Ultrasound With Invasive Right Heart Catheterization
- ClinicalTrials.gov ID
- NCT05159063
- Acronym / sponsor ID
- 67340
- Conditions
- Catheterization
- Keywords
- Internal jugular vein, Inferior vena cava, Right heart catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Gaurang VaidyaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 15 Dec 2021 (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.
The study aims to standardize patient positioning during bedside ultrasound assessment of internal jugular vein (IJV) and correlate the results with invasive hemodynamics obtained immediately after. The study hypothesizes that the respiratory variation in the size of IJV, as estimated through ultrasound at bedside, is an accurate estimation of the patient's actual right atrial pressure estimated through right heart catheterization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Right heart catheterization | – | Device: Ultrasound imaging |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients scheduled to undergo right heart catheterization.
Key inclusion criteria (1 listed)
- Undergoing right heart catheterization
Key exclusion criteria (3 listed)
- Superior vena cava obstruction or compression
- Severe tricuspid regurgitation
- Mechanically ventilated patients
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 |
|---|---|---|
| Ultrasound imagingPatients scheduled to undergo right heart catheterization (RHC) as their standard of care will be included in the study. The patient will be positioned supine at 0 degrees with normal restful breathing and patient looking straight up. After the right sternocleidomastoid muscle is identified, internal jugular vein (IJV) will be imaged at the apex of the triangle formed by the sternal and clavicular heads of the muscle. Similarly, the inferior vena cava (IVC) will be imaged at the caudal end of the sternum. The diameters of both the veins will be noted during normal respiration. The patients will then be asked to sniff and collapsibility of the veins will be noted. No pressure will be applied on the neck. The anticipated duration for image acquisition is between 5 to 10 minutes. The patients will undergo the scheduled RHC within 1 hour as scheduled. | Device | Right heart catheterization |
Primary outcome
Cross-sectional diameters of the internal jugular vein (IJV)
Time frame: 5 minutes
The respiratory variation percentage will assessed using M-mode of the ultrasound while the patient is breathing normally. The maximum and minimum anteroposterior diameter will be noted using M-mode (in mm).
Cross-sectional diameters of the internal jugular vein (IJV)
Time frame: 5 minutes
Diameter variation index will be calculated as: (maximum diameter - minimum diameter)/ body surface area.
Sniff collapsibility of IJV
Time frame: 10 minutes
Complete collapse (0cm) of the anteroposterior diameter of IJV on sniff maneuver by the patient, as assessed by M-mode on the ultrasound.
Cross-sectional diameters of the inferior vena cava (IVC)
Time frame: 5 minutes
Maximum diameter - noted using M-mode (in mm) of the ultrasound machine.
Cross-sectional diameters of the inferior vena cava (IVC)
Time frame: 5 minutes
Respiratory variation - assessed using M-mode of the ultrasound while the patient is breathing normally. This will be calculated as (maximum diameter - minimum diameter)/maximum diameter and expressed as a percentage. The maximum and minimum diameters will be noted using M-mode (in mm).
Cross-sectional diameters of the inferior vena cava (IVC)
Time frame: 5 minutes
Sniff collapsibility - Complete collapse (0cm) of the cross sectional diameter of IVC on sniff maneuver by the patient, as assessed by M-mode of the ultrasound.
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 14 Jul 2023.
- Background: PubMed 37307660Vaidya GN, Kolodziej A, Stoner B, Galaviz JV, Cao X, Heier K, Thompson M, Birks E, Campbell K. Bedside ultrasound of the internal jugular vein to assess fluid status and right ventricular function: The POCUS-JVD study. Am J Emerg Med. 2023 Aug;70:151-156. doi: 10.1016/j.ajem.2023.05.042. Epub 2023 Jun 6.
- 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.
Gaurang Vaidya, MD principal investigator
University of Kentucky
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 Catheterization, run by Gaurang Vaidya at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 14 Jul 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 States. 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?
Cross-sectional diameters of the internal jugular vein (IJV) (time frame: 5 minutes). The study lists 6 primary outcomes in all. 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 NCT05159063, 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 14 Jul 2023.