Insertion Depth of Central Venous CatheterNCT03544151
Swan-Ganz CCOmbo V for Obtaining an Optimal Depth of Right Internal Jugular Venous Catheter
An observational study of Insertion Depth of Central Venous Catheter, run by RenJi Hospital at 1 site in China.
Trial summary
The investigators will perform a study to create formula for the optimal insertion depth of right internal jugular vein catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insertion Depth of Central Venous Catheter
- What is being tested?
- Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V)
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2018to 27 Dec 2019
- 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: Patients scheduled for cardiac surgery were studied
Who may be able to join
- Adult patient over 18 years of age undergoing mitral valve or/and tricuspid valve
- Surgery under general anesthesia, requiring Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V) insertion through the right internal jugular vein.
Who cannot join
- A change in the mediastinal structure from previous neck surgery,thoracic surgery or cardiac surgery
- Extracardiac vascular anomaly
- Anatomical abnormality in neck and thorax
- Refusal to enrol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Swan-Ganz CCOmbo V for Obtaining an Optimal Depth of Right Internal Jugular Venous Catheter : A Prospective Observational Study
The investigators will perform a study to create formula for the optimal insertion depth of right internal jugular vein catheter.
Read the detailed description
Patients scheduled for cardiac surgery were studied.Determine the optimal insertion depth of right internal jugular vein catheter using Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V).The investigators measure the distance between the insertion point and the junction between right atrium and superior vena cava using Swan-Ganz CCOmbo V.
- Being tested
- Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V)Device
Swan-Ganz CCOmbo V insertion
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance
The distance between the insertion point and the junction between right atrium and superior vena cava
Measured: After insertion of the Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V) and during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start10 Jul 2018
- Primary completion25 Nov 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insertion Depth of Central Venous CatheterStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- qi lu, Dr., Study director, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544151
- Sponsor's protocol ID
- 2018-012
- Status last verified
- Mar 2020
- First submitted
- 21 May 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swan-Ganz CCOmbo V for Obtaining an Optimal Depth of Right Internal Jugular Venous Catheter : A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03544151
- Acronym / sponsor ID
- 2018-012
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 1 Jun 2018 (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 investigators will perform a study to create formula for the optimal insertion depth of right internal jugular vein catheter.
Detailed description
Patients scheduled for cardiac surgery were studied.Determine the optimal insertion depth of right internal jugular vein catheter using Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V).The investigators measure the distance between the insertion point and the junction between right atrium and superior vena cava using Swan-Ganz CCOmbo V.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for cardiac surgery were studied
Key inclusion criteria (2 listed)
- Adult patient over 18 years of age undergoing mitral valve or/and tricuspid valve
- Surgery under general anesthesia, requiring Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V) insertion through the right internal jugular vein.
Key exclusion criteria (4 listed)
- A change in the mediastinal structure from previous neck surgery,thoracic surgery or cardiac surgery
- Extracardiac vascular anomaly
- Anatomical abnormality in neck and thorax
- Refusal to enrol
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 |
|---|---|---|
| Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V)Swan-Ganz CCOmbo V insertion | Device | – |
Primary outcome
The distance
Time frame: After insertion of the Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V) and during operation
The distance between the insertion point and the junction between right atrium and superior vena cava
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 24 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Insertion Depth of Central Venous Catheter
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
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.
qi lu, Dr. study director
Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
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 Insertion Depth of Central Venous Catheter, run by RenJi Hospital at 1 site in China.
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 2 inclusion and 4 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 24 Mar 2020. 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 China. 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?
The distance (time frame: After insertion of the Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V) and during operation). 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 24 Mar 2020.