Pneumothorax Iatrogenic PostproceduralCOMBUXNCT02959203
Comparison of Bedside Ultrasound With Chest X-ray for Confirmation of Central Venous Catheter Position
An observational study of Pneumothorax Iatrogenic Postprocedural and Malposition, Central Venous Catheter, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Background: Insertion of a central venous catheter (CVC) could lead to a variety of complications. To detect those complications, Chest X-ray (CXR) is still the reference standard. However, there are major limitations in performing CXR's in the critical care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax Iatrogenic Postprocedural, Malposition, Central Venous Catheter
- How many people
- 750 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2016to Dec 2017
- 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 who undergo central venous cannulation
Who may be able to join
- Age above 18
- Central venous cannulation performed
- CVC in internal jugular vein or subclavian vein
Who cannot join
- Refusal to undergo ultrasound examination
- Refusal to undergo chest X-ray
- CVC in femoral vein
- PICC
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1081 HZ
About this study
Official title: Comparison of Bedside Ultrasound With Chest X-ray to Detect CVC Related Mechanical Complications; a Prospective Observational Study (COMBUX-study)
Background:
Insertion of a central venous catheter (CVC) could lead to a variety of complications.
Read more
To detect those complications, Chest X-ray (CXR) is still the reference standard. However, there are major limitations in performing CXR's in the critical care setting.
Aim/objectives:
The objective of this study is to compare the use of bedside ultrasound (US) to conventional CXR in visualization of accuracy and safety of the CVC placement. The aim is to eventually replace X-ray with bedside ultrasound as gold standard for the confirmation of CVC-placement in critically ill patients, thereby reducing radiation exposure and unnecessary delay before CVC use.
Methods:
The bedside US will be performed by the student or attending physician, who is blinded for CXR findings. After US examination, the attending physician (or student) will fill in a structured form, based on an established protocol. CXR will be performed before or after US examination and assessed by a radiologist. The radiologist will be blinded for the findings of the bedside ultrasound to prevent any biases. Final diagnosis will be determined after examination of the complete medical chart.
Read the detailed description
Most patients admitted to an intensive care unit undergo central venous catheterization (CVC) or already have received a CVC. Over 5 million CVC placements are performed each year in the United States. An indication of central venous access is for example when peripheral veins are inaccessible or for the administration of potent vasoactive drugs such as norepinephrine or dopamine. Three anatomical sites are frequently used to insert a CVC: the subclavian, jugular and femoral site. Although central venous catheterization offers multiple advantages, it is associated with adverse events that could be hazardous for patients. Mechanical, infectious or thrombotic complications could occur. Most common mechanical complications include arterial puncture, hematoma and pneumothorax. Besides mechanical complications, malposition of a CVC could also lead to complications, including phlebitis, perforation, and venous thrombosis or occlusion. Malposition of the CVC tip into the right atrium could also lead to arrhythmias. The frequency of primary mal-positioning has been shown to be up to 3.7%. A recent multicenter trial, which included 3471 catheters in 3027 patients, showed that subclavian-vein catheterization was associated with a lower risk of bloodstream infection and symptomatic thrombosis but involved a higher risk of pneumothorax as compared to jugular-vein or femoral-vein catheterization. The risk of mechanical complications in subclavian, jugular or femoral catheterization was 2.1%, 1.4% and 6% respectively.
To date, the post-procedural chest X-ray (CXR) has been the reference standard to detect these mechanical complications. Some studies suggest that it should not be considered a reliable procedure for detecting complications in the absence of clinical symptoms. In addition, reading of a bedside CXR alone is not very accurate to identify intra-atrial tip position. The exceedingly low complication rate after right internal jugular vein catheterization suggests that, to detect pneumothorax and intra-atrial malposition, routine post-procedure CXR is neither necessary nor accurate and causes delay until catheter use. Omitting the need for CXR could reduce healthcare costs as well.
Due to some clear advantages, there has already been an increasing role for ultrasonography in the critical care setting. In comparison to radiography, an advantage of ultrasound is that the patient is not exposed to radiation, and is often faster performed. Compared to the traditional 'blind' landmark method, ultrasound-guided subclavian cannulation reduces failed catheterizations and complications associated with subclavian catheterization. Advantages of ultrasound-guided cannulation include correct identification of the vein, detecting variable anatomy and reducing events of arterial puncture. Due to the developing knowledge and techniques in ultrasound, is has been suggested that it would be a suitable method to replace CXR in the role of detecting pneumothorax and identifying CVC tip position. A small number of studies already demonstrated this effect.
In this study we evaluate the use of ultrasound as diagnostic modality in patients after CVC placement in the subclavian or jugular vein. This research proposal aims to evaluate US examination as diagnostic tool for misplacement, bleeding and pneumothorax after CVC-placement. Combining the different strategies from previous studies. we developed "tHe UltraSound evaluation of Cvc Insertion" i.e. HUSCI-protocol. Hereby, we aim to improve accuracy The outcome measure will be the sensitivity and specificity of US. In addition, diagnostic concordance between US and CXR in patients after CVC placement will be studied. If US catches clinical relevant findings accurately we can replace standard expensive and harmful CXR as standard diagnostic tool in patients after CVC-placement in the future. We hypothesize that US can confirm correct CVC placement and detect potential associated complications accurately.
- Keywords
- Central Venous Catheter, Ultrasound, Chest X-ray, Pneumothorax
- Medical subject headings
- Pneumothorax
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of ultrasound to detect CVC malposition
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) are used as accuracy outcome parameters. A 'true positive' result is defined as an US-suggested aberrant position of the CVC (catheter tip in any other vein than the superior vena cava (SVC), outside the venous system, or positioned deep in the right atrium or ventricle) confirmed by CXR. If bedside US rules out an aberrant position of the catheter tip correctly it is considered to be a 'true negative' result
Measured: Accuracy will be measured after ultrasound and Chest X-ray evaluation (expected time frame: 3 hours)
Secondary outcomes (2)
Feasibility of ultrasound
Ultrasound is considered to be feasible if all US-views in the protocol can be obtained
Measured: Feasiblity will be measured after ultrasound and Chest X-ray evaluation (expected time frame: 3 hours)
Diagnostic accuracy of ultrasound to detect pneumothorax
Interobserver and overall percent agreement between US and CXR is calculated
Measured: Accuracy will be measured after ultrasound and Chest X-ray evaluation (expected time frame: 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Pneumothorax Iatrogenic PostproceduralStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Groene Hart Ziekenhuis
- Responsible party
- Principal investigator, Jasper Smit, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959203
- Sponsor's protocol ID
- 2016.053
- Acronym
- COMBUX
- Status last verified
- Feb 2018
- First submitted
- 4 Nov 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hourmozdi JJ, Markin A, Johnson B, Fleming PR, Miller JB. Routine Chest Radiography Is Not Necessary After Ultrasound-Guided Right Internal Jugular Vein Catheterization. Crit Care Med. 2016 Sep;44(9):e804-8. doi: 10.1097/CCM.0000000000001737.
PubMed 27035241Lalu MM, Fayad A, Ahmed O, Bryson GL, Fergusson DA, Barron CC, Sullivan P, Thompson C; Canadian Perioperative Anesthesia Clinical Trials Group. Ultrasound-Guided Subclavian Vein Catheterization: A Systematic Review and Meta-Analysis. Crit Care Med. 2015 Jul;43(7):1498-507. doi: 10.1097/CCM.0000000000000973.
PubMed 25803646Lichtenstein D, van Hooland S, Elbers P, Malbrain ML. Ten good reasons to practice ultrasound in critical care. Anaesthesiol Intensive Ther. 2014 Nov-Dec;46(5):323-35. doi: 10.5603/AIT.2014.0056.
PubMed 25432552Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.
PubMed 26398070Zadeh MK, Shirvani A. The role of routine chest radiography for detecting complications after central venous catheter insertion. Saudi J Kidney Dis Transpl. 2014 Sep;25(5):1011-6. doi: 10.4103/1319-2442.139895.
PubMed 25193899Vezzani A, Manca T, Vercelli A, Braghieri A, Magnacavallo A. Ultrasonography as a guide during vascular access procedures and in the diagnosis of complications. J Ultrasound. 2013 Oct 29;16(4):161-70. doi: 10.1007/s40477-013-0046-5. eCollection 2013 Oct 29.
PubMed 24432170Nayeemuddin M, Pherwani AD, Asquith JR. Imaging and management of complications of central venous catheters. Clin Radiol. 2013 May;68(5):529-44. doi: 10.1016/j.crad.2012.10.013. Epub 2013 Feb 13.
PubMed 23415017Wirsing M, Schummer C, Neumann R, Steenbeck J, Schmidt P, Schummer W. Is traditional reading of the bedside chest radiograph appropriate to detect intraatrial central venous catheter position? Chest. 2008 Sep;134(3):527-533. doi: 10.1378/chest.07-2687. Epub 2008 Jul 18.
PubMed 18641117Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. doi: 10.1097/01.CCM.0000260241.80346.1B.
PubMed 17414086McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.
PubMed 12646670Bedel J, Vallee F, Mari A, Riu B, Planquette B, Geeraerts T, Genestal M, Minville V, Fourcade O. Guidewire localization by transthoracic echocardiography during central venous catheter insertion: a periprocedural method to evaluate catheter placement. Intensive Care Med. 2013 Nov;39(11):1932-7. doi: 10.1007/s00134-013-3097-3. Epub 2013 Sep 20.
PubMed 24052186Cortellaro F, Mellace L, Paglia S, Costantino G, Sher S, Coen D. Contrast enhanced ultrasound vs chest x-ray to determine correct central venous catheter position. Am J Emerg Med. 2014 Jan;32(1):78-81. doi: 10.1016/j.ajem.2013.10.001. Epub 2013 Oct 9.
PubMed 24184012Vezzani A, Brusasco C, Palermo S, Launo C, Mergoni M, Corradi F. Ultrasound localization of central vein catheter and detection of postprocedural pneumothorax: an alternative to chest radiography. Crit Care Med. 2010 Feb;38(2):533-8. doi: 10.1097/CCM.0b013e3181c0328f.
PubMed 19829102Gekle R, Dubensky L, Haddad S, Bramante R, Cirilli A, Catlin T, Patel G, D'Amore J, Slesinger TL, Raio C, Modayil V, Nelson M. Saline Flush Test: Can Bedside Sonography Replace Conventional Radiography for Confirmation of Above-the-Diaphragm Central Venous Catheter Placement? J Ultrasound Med. 2015 Jul;34(7):1295-9. doi: 10.7863/ultra.34.7.1295.
PubMed 26112633Kim SC, Graff I, Sommer A, Hoeft A, Weber S. Ultrasound-guided supraclavicular central venous catheter tip positioning via the right subclavian vein using a microconvex probe. J Vasc Access. 2016 Sep 21;17(5):435-9. doi: 10.5301/jva.5000518. Epub 2016 Mar 22.
PubMed 27012271
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bedside Ultrasound With Chest X-ray to Detect CVC Related Mechanical Complications; a Prospective Observational Study (COMBUX-study)
- ClinicalTrials.gov ID
- NCT02959203
- Acronym / sponsor ID
- COMBUX / 2016.053
- Keywords
- Central Venous Catheter, Ultrasound, Chest X-ray, Pneumothorax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Groene Hart Ziekenhuis
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Nov 2016 (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.
Background:
Insertion of a central venous catheter (CVC) could lead to a variety of complications.
To detect those complications, Chest X-ray (CXR) is still the reference standard. However, there are major limitations in performing CXR's in the critical care setting.
Aim/objectives:
The objective of this study is to compare the use of bedside ultrasound (US) to conventional CXR in visualization of accuracy and safety of the CVC placement. The aim is to eventually replace X-ray with bedside ultrasound as gold standard for the confirmation of CVC-placement in critically ill patients, thereby reducing radiation exposure and unnecessary delay before CVC use.
Methods:
The bedside US will be performed by the student or attending physician, who is blinded for CXR findings. After US examination, the attending physician (or student) will fill in a structured form, based on an established protocol. CXR will be performed before or after US examination and assessed by a radiologist. The radiologist will be blinded for the findings of the bedside ultrasound to prevent any biases. Final diagnosis will be determined after examination of the complete medical chart.
Detailed description
Most patients admitted to an intensive care unit undergo central venous catheterization (CVC) or already have received a CVC. Over 5 million CVC placements are performed each year in the United States. An indication of central venous access is for example when peripheral veins are inaccessible or for the administration of potent vasoactive drugs such as norepinephrine or dopamine. Three anatomical sites are frequently used to insert a CVC: the subclavian, jugular and femoral site. Although central venous catheterization offers multiple advantages, it is associated with adverse events that could be hazardous for patients. Mechanical, infectious or thrombotic complications could occur. Most common mechanical complications include arterial puncture, hematoma and pneumothorax. Besides mechanical complications, malposition of a CVC could also lead to complications, including phlebitis, perforation, and venous thrombosis or occlusion. Malposition of the CVC tip into the right atrium could also lead to arrhythmias. The frequency of primary mal-positioning has been shown to be up to 3.7%. A recent multicenter trial, which included 3471 catheters in 3027 patients, showed that subclavian-vein catheterization was associated with a lower risk of bloodstream infection and symptomatic thrombosis but involved a higher risk of pneumothorax as compared to jugular-vein or femoral-vein catheterization. The risk of mechanical complications in subclavian, jugular or femoral catheterization was 2.1%, 1.4% and 6% respectively.
To date, the post-procedural chest X-ray (CXR) has been the reference standard to detect these mechanical complications. Some studies suggest that it should not be considered a reliable procedure for detecting complications in the absence of clinical symptoms. In addition, reading of a bedside CXR alone is not very accurate to identify intra-atrial tip position. The exceedingly low complication rate after right internal jugular vein catheterization suggests that, to detect pneumothorax and intra-atrial malposition, routine post-procedure CXR is neither necessary nor accurate and causes delay until catheter use. Omitting the need for CXR could reduce healthcare costs as well.
Due to some clear advantages, there has already been an increasing role for ultrasonography in the critical care setting. In comparison to radiography, an advantage of ultrasound is that the patient is not exposed to radiation, and is often faster performed. Compared to the traditional 'blind' landmark method, ultrasound-guided subclavian cannulation reduces failed catheterizations and complications associated with subclavian catheterization. Advantages of ultrasound-guided cannulation include correct identification of the vein, detecting variable anatomy and reducing events of arterial puncture. Due to the developing knowledge and techniques in ultrasound, is has been suggested that it would be a suitable method to replace CXR in the role of detecting pneumothorax and identifying CVC tip position. A small number of studies already demonstrated this effect.
In this study we evaluate the use of ultrasound as diagnostic modality in patients after CVC placement in the subclavian or jugular vein. This research proposal aims to evaluate US examination as diagnostic tool for misplacement, bleeding and pneumothorax after CVC-placement. Combining the different strategies from previous studies. we developed "tHe UltraSound evaluation of Cvc Insertion" i.e. HUSCI-protocol. Hereby, we aim to improve accuracy The outcome measure will be the sensitivity and specificity of US. In addition, diagnostic concordance between US and CXR in patients after CVC placement will be studied. If US catches clinical relevant findings accurately we can replace standard expensive and harmful CXR as standard diagnostic tool in patients after CVC-placement in the future. We hypothesize that US can confirm correct CVC placement and detect potential associated complications accurately.
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 who undergo central venous cannulation
Key inclusion criteria (3 listed)
- Age above 18
- Central venous cannulation performed
- CVC in internal jugular vein or subclavian vein
Key exclusion criteria (4 listed)
- Refusal to undergo ultrasound examination
- Refusal to undergo chest X-ray
- CVC in femoral vein
- PICC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of ultrasound to detect CVC malposition
Time frame: Accuracy will be measured after ultrasound and Chest X-ray evaluation (expected time frame: 3 hours)
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) are used as accuracy outcome parameters. A 'true positive' result is defined as an US-suggested aberrant position of the CVC (catheter tip in any other vein than the superior vena cava (SVC), outside the venous system, or positioned deep in the right atrium or ventricle) confirmed by CXR. If bedside US rules out an aberrant position of the catheter tip correctly it is considered to be a 'true negative' result
2 secondary outcomes
Feasibility of ultrasound
Time frame: Feasiblity will be measured after ultrasound and Chest X-ray evaluation (expected time frame: 3 hours)
Diagnostic accuracy of ultrasound to detect pneumothorax
Time frame: Accuracy will be measured after ultrasound and Chest X-ray evaluation (expected time frame: 3 hours)
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 22 Feb 2018.
- Background: PubMed 27035241Hourmozdi JJ, Markin A, Johnson B, Fleming PR, Miller JB. Routine Chest Radiography Is Not Necessary After Ultrasound-Guided Right Internal Jugular Vein Catheterization. Crit Care Med. 2016 Sep;44(9):e804-8. doi: 10.1097/CCM.0000000000001737.
- Background: PubMed 25803646Lalu MM, Fayad A, Ahmed O, Bryson GL, Fergusson DA, Barron CC, Sullivan P, Thompson C; Canadian Perioperative Anesthesia Clinical Trials Group. Ultrasound-Guided Subclavian Vein Catheterization: A Systematic Review and Meta-Analysis. Crit Care Med. 2015 Jul;43(7):1498-507. doi: 10.1097/CCM.0000000000000973.
- Background: PubMed 25432552Lichtenstein D, van Hooland S, Elbers P, Malbrain ML. Ten good reasons to practice ultrasound in critical care. Anaesthesiol Intensive Ther. 2014 Nov-Dec;46(5):323-35. doi: 10.5603/AIT.2014.0056.
- Background: PubMed 26398070Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.
- Background: PubMed 25193899Zadeh MK, Shirvani A. The role of routine chest radiography for detecting complications after central venous catheter insertion. Saudi J Kidney Dis Transpl. 2014 Sep;25(5):1011-6. doi: 10.4103/1319-2442.139895.
- Background: PubMed 24432170Vezzani A, Manca T, Vercelli A, Braghieri A, Magnacavallo A. Ultrasonography as a guide during vascular access procedures and in the diagnosis of complications. J Ultrasound. 2013 Oct 29;16(4):161-70. doi: 10.1007/s40477-013-0046-5. eCollection 2013 Oct 29.
- Background: PubMed 23415017Nayeemuddin M, Pherwani AD, Asquith JR. Imaging and management of complications of central venous catheters. Clin Radiol. 2013 May;68(5):529-44. doi: 10.1016/j.crad.2012.10.013. Epub 2013 Feb 13.
- Background: PubMed 18641117Wirsing M, Schummer C, Neumann R, Steenbeck J, Schmidt P, Schummer W. Is traditional reading of the bedside chest radiograph appropriate to detect intraatrial central venous catheter position? Chest. 2008 Sep;134(3):527-533. doi: 10.1378/chest.07-2687. Epub 2008 Jul 18.
- Background: PubMed 17414086Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. doi: 10.1097/01.CCM.0000260241.80346.1B.
- Background: PubMed 12646670McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.
- Background: PubMed 24052186Bedel J, Vallee F, Mari A, Riu B, Planquette B, Geeraerts T, Genestal M, Minville V, Fourcade O. Guidewire localization by transthoracic echocardiography during central venous catheter insertion: a periprocedural method to evaluate catheter placement. Intensive Care Med. 2013 Nov;39(11):1932-7. doi: 10.1007/s00134-013-3097-3. Epub 2013 Sep 20.
- Background: PubMed 24184012Cortellaro F, Mellace L, Paglia S, Costantino G, Sher S, Coen D. Contrast enhanced ultrasound vs chest x-ray to determine correct central venous catheter position. Am J Emerg Med. 2014 Jan;32(1):78-81. doi: 10.1016/j.ajem.2013.10.001. Epub 2013 Oct 9.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pneumothorax Iatrogenic Postprocedural and Malposition, Central Venous Catheter, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 22 Feb 2018. 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 Netherlands. 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?
Diagnostic accuracy of ultrasound to detect CVC malposition (time frame: Accuracy will be measured after ultrasound and Chest X-ray evaluation (expected time frame: 3 hours)). 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 NCT02959203, which also lists 16 linked publications.
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 22 Feb 2018.