Catheterization, Central VenousNCT00388375
Can Ultrasound be Used to Verify CVC Position and to Exclude Pneumothorax?
A study testing Ultrasound in people with Catheterization, Central Venous, run by Christiana Care Health Services at 1 site in United States.
Trial summary
The purpose of this study is to determine if emergency room physicians can use bedside ultrasound to quickly determine the proper placement of a central venous catheter and to evaluate for complications such as a punctured lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Central Venous
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2008
- Phase
- Interventional
- 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
Who may be able to join
- Male or female 18 years or older
- Signed consent
- In need of subclavian or internal jugular central line placement
Who cannot join
- Any subject who refuses or whose family refuses to sign consent
- Any subject in whose immediate transfer from the care of the ED to another location is mandated by clinical presentation
- Any subject under the age of 18
- Any subject being evaluated for chest trauma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Heath System
Newark, Delaware, 19718
About this study
Official title: Can Ultrasound be Used as an Alternative to Chest Radiography After Central Venous Catheter Insertion to Confirm Proper Catheter Position and to Exclude Pneumothorax?
The purpose of this study is to determine if emergency room physicians can use bedside ultrasound to quickly determine the proper placement of a central venous catheter and to evaluate for complications such as a punctured lung.
Read the detailed description
Central venous catheterization (CVC) of the subclavian or internal jugular veins is a common procedure performed in the emergency department (ED). This procedure is followed by complications in 0.3 to 12% of cases. Pneumothorax (PTX) and catheter-tip misplacement can occur. The diagnosis of these complications requires a chest radiograph (CXR). In certain cases, CXR may be time-consuming, requiring more than 30 minutes. This could be harmful in the case of critically ill patients. Moreover, several investigators have questioned the need of routine post-procedural CXR in the absence of clinical complications.
Recent data has shown that ultrasound can accurately detect PTX in critically ill patients. Furthermore, bedside ultrasound is an easy technique to investigate the subclavian and internal jugular veins, and can improve the success rate of catheter insertion. Ultrasound also allows visualization of central venous catheters in vivo. Ultrasound has been reported as a tool to detect catheterization complications and misplacement when performed by ICU physicians, but has never been studied in the ED.
This method could be valuable in hemodynamically unstable patients, who quickly need a CVC for the measurement of central venous pressure, immediate fluid resuscitation, and infusion of vasoactive medications. Similarly, bedside ultrasound examination could quickly confirm PTX and allow immediate chest tube insertion in case of respiratory distress after catheter insertion.
We hypothesize that bedside ultrasound examination performed by ED physicians could accurately detect placement of the CVC and the presence or absence of a PTX after catheterization of the jugular and subclavian veins.
- Conditions
- Catheterization, Central Venous
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
limited ultrasound examination to evaluate the following areas: Examination of the subclavian and internal jugular veins to assess proper catheter placement PTX detection, using lung sliding and comet-tail artifact Visualization of the heart (right atrium and ventricle) and the inferior vena cava through the subcostal window
| Study group | Role | What they receive |
|---|---|---|
| CVC Internal Jugular or Subclavian Vein | No intervention | Not described Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence or absence of a misplaced CVC as detected by US and CXR.
Measured: 10 Minutes
The presence or absence of PTX as detected by US and CXR
Measured: 10 minutes
Secondary outcomes (1)
Time needed to complete the US exam and CXR
Measured: varies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Not feasible, did not have the study population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheterization, Central VenousStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Nomura, MD, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388375
- Sponsor's protocol ID
- 25185
- Status last verified
- Nov 2012
- First submitted
- 12 Oct 2006
- Last updated
- 20 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Ultrasound be Used as an Alternative to Chest Radiography After Central Venous Catheter Insertion to Confirm Proper Catheter Position and to Exclude Pneumothorax?
- ClinicalTrials.gov ID
- NCT00388375
- Acronym / sponsor ID
- 25185
- Conditions
- Catheterization, Central Venous
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not feasible, did not have the study population.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Oct 2006 (estimated)
- 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 purpose of this study is to determine if emergency room physicians can use bedside ultrasound to quickly determine the proper placement of a central venous catheter and to evaluate for complications such as a punctured lung.
Detailed description
Central venous catheterization (CVC) of the subclavian or internal jugular veins is a common procedure performed in the emergency department (ED). This procedure is followed by complications in 0.3 to 12% of cases. Pneumothorax (PTX) and catheter-tip misplacement can occur. The diagnosis of these complications requires a chest radiograph (CXR). In certain cases, CXR may be time-consuming, requiring more than 30 minutes. This could be harmful in the case of critically ill patients. Moreover, several investigators have questioned the need of routine post-procedural CXR in the absence of clinical complications.
Recent data has shown that ultrasound can accurately detect PTX in critically ill patients. Furthermore, bedside ultrasound is an easy technique to investigate the subclavian and internal jugular veins, and can improve the success rate of catheter insertion. Ultrasound also allows visualization of central venous catheters in vivo. Ultrasound has been reported as a tool to detect catheterization complications and misplacement when performed by ICU physicians, but has never been studied in the ED.
This method could be valuable in hemodynamically unstable patients, who quickly need a CVC for the measurement of central venous pressure, immediate fluid resuscitation, and infusion of vasoactive medications. Similarly, bedside ultrasound examination could quickly confirm PTX and allow immediate chest tube insertion in case of respiratory distress after catheter insertion.
We hypothesize that bedside ultrasound examination performed by ED physicians could accurately detect placement of the CVC and the presence or absence of a PTX after catheterization of the jugular and subclavian veins.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVC Internal Jugular or Subclavian Vein | No intervention | Procedure: Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female 18 years or older
- Signed consent
- In need of subclavian or internal jugular central line placement
Key exclusion criteria (4 listed)
- Any subject who refuses or whose family refuses to sign consent
- Any subject in whose immediate transfer from the care of the ED to another location is mandated by clinical presentation
- Any subject under the age of 18
- Any subject being evaluated for chest trauma.
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 |
|---|---|---|
| Ultrasoundlimited ultrasound examination to evaluate the following areas: Examination of the subclavian and internal jugular veins to assess proper catheter placement PTX detection, using lung sliding and comet-tail artifact Visualization of the heart (right atrium and ventricle) and the inferior vena cava through the subcostal window | Procedure or surgery | CVC Internal Jugular or Subclavian Vein |
Primary outcome
The presence or absence of a misplaced CVC as detected by US and CXR.
Time frame: 10 Minutes
The presence or absence of PTX as detected by US and CXR
Time frame: 10 minutes
1 secondary outcome
Time needed to complete the US exam and CXR
Time frame: varies
Results and safety
The study was stopped early (reason given: Not feasible, did not have the study population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
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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.
Jason Nomura, MD principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Catheterization, Central Venous, run by Christiana Care Health Services 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 3 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: stopped early, as of the sponsor's last update on 20 Oct 2014. 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 was stopped early (reason given: Not feasible, did not have the study population.). Results are not available in the source record.
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 presence or absence of a misplaced CVC as detected by US and CXR. (time frame: 10 Minutes). The study lists 2 primary outcomes in all. 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 20 Oct 2014.