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Central Venous CatheterizationNCT03442790

Agitated Saline Versus CXR Confirmation of Central Venous Lines

A study testing Agitated Saline Method and chest x-ray in people with Central Venous Catheterization and Exposure to X-Rays, run by Nepal Mediciti Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Central venous lines insertion are common procedures these days. CVL placed under USG guidance have high success rates and low complications even in developing country settings. However, the investigators still have to rely on chest x-ray (CXR) to confirm the correct placement of central venous lines as a gold… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Agitated Saline Method and chest x-ray
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
No sites listed yet
Study dates
1 May 2018to 1 Dec 2018
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

  • Patients > 18 years admitted to ICU or presenting to operation theater for surgical procedures
  • Patients with indications for above the diaphragm CVL placement
  • All above the diaphragm central venous lines placed under ultrasound guidance.

Who cannot join

  • Age <18 years
  • Pregnant patients
  • Patients with moderate and severe RV dysfunction
  • Patient with moderate and severe tricuspid regurgitation

Trial locations and contacts

No sites are listed yet.

About this study

Official title: Agitated Saline Versus Chest X-ray for Determination of Correct Position of Central Venous Catheter: a Non-inferiority Study

Central venous lines insertion are common procedures these days. CVL placed under USG guidance have high success rates and low complications even in developing country settings. However, the investigators still have to rely on chest x-ray (CXR) to confirm the correct placement of central venous lines as a gold standard method. This might be time consuming and may cause delay in initiation of treatment. In some cases, as in operating room, the treatment is started even before confirmation by CXR. Ultrasound has ability to localize the tip of the catheter at the superior venacava- right atrium junction using agitated saline and the appearance of contrast within 2 seconds in right atrium. However, this technique is rarely used. The investigators, therefore, designed the trial to study whether confirmation of tip of CVL by ultrasound is non-inferior to the CXR confirmation.

Read the detailed description

Central venous lines (CVL) are placed in various in-hospital settings like operation theaters, emergency departments, oncology departments, and intensive care units for various purposes. Like any invasive procedures, placement of central lines is invariably associated with certain risks of inadvertent complications which are often life-threatening which occur because of the intricacy of the structures around the vascular access site like pleura, arteries, nerves, heart, etc. Measures such as landmark guidance, electrocardiographic guidance, fluoroscopy/C-arm-guided, and recently ultrasound image guidance have been in place to prevent and/or minimize the occurrence of such complications. Although the incidence of such complications have decreased considerably4, the rates have not reached the nadir.

Failure of confirmation of the correct placement of a CVL can have serious consequences. The consequences of an inadvertently misplaced catheter are grave for the patient be it the failure to elicit the vasopressor effect, unnecessary delay in starting of caustic substances like hypertonic fluids, parenteral nutrition, concentrated agents, etc., these will ultimately increase the morbidity and mortality. Thus, it becomes imperative that we confirm the accurate placement of CVL before infusing anything through these lines.

The confirmation of accurate placement of CVL is usually done by performing a post-procedure chest x-ray (CXR) which is done at the point of care if possible like in ICU or after shifting of patient to a post-operative ward in an operation theater setup. The most important constraint in obtaining CXR after CVL placement is the considerable amount of time it takes before a film is obtained even in center where there is a dedicated portable CXR for that purpose. For CVL placed in the operating theater, it is not always possible to do a portable CXR immediately after the procedure and at many times we have to immediately start infusion/medications through it even before confirmation of their proper placement. Secondly the very well-known problem of radiation hazard is a potential deterrent to the use of CXR each time a CVL is placed. When a large volume ICU is compared, the risk of radiation is inadvertently extended to all of the patients even though lines are placed in some. The hazard of the radiation to the ICU and ED staffs is always a concern considering the difficulty they face in escaping the hazard when they are taking care of sick patients. Thirdly, it is difficult to obtain an accurate CXR film in critical care unit setups where the patient are sometimes unable to hold breaths at inspiration (for the proper x-ray film) and the film so obtained may not be reliable enough to read. Fourthly, the overall costs in obtaining CXR for each and every single central lines placed will add to the overall healthcare costs at a time when the investigators are looking for reasons to cut down on health expenses.

Considering the fact that these lines are placed under ultrasound guidance, the rate of inadvertent complications are very few. But subjecting every single individual to an x-ray cannot always be justified. Nevertheless, this is not to say that central lines should not be confirmed for their proper placement, but certainly there is an imminent need of a simple, reliable, and more cost effective alternative to CXR. The very same ultrasound machine at point of care can be utilized for this purpose addressing most of the limitations of the CXR.

With simple, directed teaching it is possible for anyone with basic knowledge in ultrasound to do a focused point of care ultrasound to evaluate the accurate placement of CVL. This simple approach has several potential benefits. The first one being the saving of precious post-procedure time that is lost in obtaining a chest x-ray. The potential radiation hazard due to CXR is virtually eliminated. The same ultrasound can also be utilized for scanning the thorax to exclude pneumothorax and hemothorax and avoid potential delay in their management. If the sensitivity and specificity of ultrasound in accurately delineating the position of CVL is comparable to the chest x-ray, then obtaining of chest x-ray for confirmation can virtually be eliminated.

Although, it is possible to see the intravascularly placed CVL by scanning the respective vessel and visualizing the acoustic shadow in transverse axis and following the same in longitudinal axis, there is a limitation to the extent these lines can be followed to. The user who is usually positioned just above the head has access to scan the neck veins and follow the vessels until the bony structures like clavicle and ribs limit further interpretation unless we are using a transesophageal echocardiography. Thus, experts have devised a noble technique of using agitated saline as contrast agent to check the accurate location of central line. When performed properly, the contrast agent which is injected through the distal most port of central line will create a wave of microbubbles appearing to enter the right atrium from superior venacava and the relative time it takes for these bubbles to appear help interpret the position of CVL with a relatively high degree of sensitivity and specificity. This simple yet effective method is not expected to take a long time to perform. However, not all the studies thus performed so far have been consistent in obtaining a conclusive evidence of its effectivity and sensitivity. Most of the studies done till date have been relatively underpowered by a small sample size to draw a major conclusion as to justify the use of ultrasound in detection of CVL placement. This very finding dictates the necessity of conducting even more studies in diverse groups of population before a concrete conclusion is drawn. Unlike previous studies where the ultrasound was compared as an absolute method to completely replace the CXR in confirmation of CVL which still seems to be far-fetched idea, the investigators seek to see that ultrasound guided agitated saline method of confirmation is not inferior to chest x-ray in confirming or refuting the accurate placement of CVL. By this study, the investigators do not at all seek to completely eliminate chest x-ray in confirmation of CVL but at least make an interpretation by using appropriate tests that ultrasound has the potential to be effective in decreasing the necessity of CXR in post-CVL insertion confirmation. The investigators believe that rather than subjecting every single person to radiation hazard after CVL, it is justifiable to obtain CXR only in those cases where there is confirmatory dilemma with agitated saline. Till date, there are also no specific guides to accurately predict the length at which the CVL should be fixed at skin before any form of confirmation can be done. The investigators assume that with this study, they will be able to better able to tell what is the most appropriate length of CVL fixing which can be extended to other patients of similar population group. Also, the investigators presume that it is possible to virtually eliminate a large numbers of unnecessary x-rays including all of their hazards and also cut down the healthcare costs. The investigators also believe that in the due course of time, with this and other similar and sufficiently powered studies, it will be possible to draw a firm conclusion and use ultrasound as an effective tool for its varied purposes in intensive care and emergency settings.

Being tested
Agitated Saline Method, chest x-ray
Keywords
CVC confirmation, Agitated Saline, CXR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Agitated Saline MethodProcedure or surgery

    Also called bubble confirmation, contrast enhanced confirmation

    All patients in the study who have undergone a central venous line placement will undergo a confirmation of the accurate or inaccurate placement of central venous lines using agitated saline under ultrasound vision.

  • chest x-rayProcedure or surgery

    Also called CXR, supine x-ray

    All patients in the study who have undergone a central venous line placement will undergo a confirmation of the accurate or inaccurate placement of central venous lines using chest x-ray obtained in supine position as an active comparator

Study groups in NCT03442790
Study groupRoleWhat they receive
Agitated Saline MethodExperimentalThe proper placement of the central venous line will be confirmed using agitated saline under ultrasound vision
Receives: Procedure: Agitated Saline Method; Procedure: chest x-ray
Chest X-Ray ConfirmationActive comparatorThe proper placement of the central venous line will be compared with chest x-ray obtained in supine position after central line placement
Receives: Procedure: Agitated Saline Method; Procedure: chest x-ray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of central line placement

    1. To compare the accuracy of ultrasound guided agitated saline confirmation and chest x-ray confirmation of central venous line position

    Measured: 7 months

Secondary outcomes (2)
  1. Compare the time required for confirmation

    To compare the time required for ultrasound guided agitated saline confirmation and chest x-ray confirmation of central venous line position

    Measured: 7 months

  2. Accuracy of malposition detection

    To compare the accuracy of detection of central venous line malposition

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2018
  2. Study start1 May 2018 (estimated)
  3. Primary completion1 Sep 2018 (estimated)
  4. Study completion1 Dec 2018 (estimated)

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03442790
Sponsor's protocol ID
NepalMediciti
Status last verified
Apr 2018
First submitted
10 Feb 2018
Last updated
10 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mulvany SA, Mcconkey C, Allen S. An Audit of Central Venous Line Insertion, the use of Ultrasound Guidance and the Incidence of Carotid Artery Puncture. Int J Perioper Ultrasound Appl Technol Int J Periop Ultrasound Appl Technol. 2012;1(33):99-101.

  • Joshi AM, Bhosale GP, Parikh GP, Shah VR. Optimal positioning of right-sided internal jugular venous catheters: comparison of intra-atrial electrocardiography versus Peres' formula. Indian J Crit Care Med. 2008 Jan;12(1):10-4. doi: 10.4103/0972-5229.40943.

    PubMed 19826584
  • Gebauer B, Teichgraber UM, Werk M, Beck A, Wagner HJ. Sonographically guided venous puncture and fluoroscopically guided placement of tunneled, large-bore central venous catheters for bone marrow transplantation-high success rates and low complication rates. Support Care Cancer. 2008 Aug;16(8):897-904. doi: 10.1007/s00520-007-0378-9. Epub 2008 Jan 16.

    PubMed 18197436
  • Palepu GB, Deven J, Subrahmanyam M, Mohan S. Impact of ultrasonography on central venous catheter insertion in intensive care. Indian J Radiol Imaging. 2009 Jul-Sep;19(3):191-8. doi: 10.4103/0971-3026.54877.

    PubMed 19881083
  • Pikwer A, Baath L, Davidson B, Perstoft I, Akeson J. The incidence and risk of central venous catheter malpositioning: a prospective cohort study in 1619 patients. Anaesth Intensive Care. 2008 Jan;36(1):30-7. doi: 10.1177/0310057X0803600106.

    PubMed 18326129
  • Matsushima K, Frankel HL. Bedside ultrasound can safely eliminate the need for chest radiographs after central venous catheter placement: CVC sono in the surgical ICU (SICU). J Surg Res. 2010 Sep;163(1):155-61. doi: 10.1016/j.jss.2010.04.020. Epub 2010 May 11.

    PubMed 20599208
  • Xie Z, Liao X, Kang Y, Zhang J, Jia L. Radiation Exposure to Staff in Intensive Care Unit with Portable CT Scanner. Biomed Res Int. 2016;2016:5656480. doi: 10.1155/2016/5656480. Epub 2016 Jul 31.

    PubMed 27556036
  • Andropoulos DB, Stayer SA, Bent ST, Campos CJ, Bezold LI, Alvarez M, Fraser CD. A controlled study of transesophageal echocardiography to guide central venous catheter placement in congenital heart surgery patients. Anesth Analg. 1999 Jul;89(1):65-70. doi: 10.1097/00000539-199907000-00012.

    PubMed 10389780
  • Cortellaro 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 24184012
  • Rezayat T, Stowell JR, Kendall JL, Turner E, Fox JC, Barjaktarevic I. Ultrasound-Guided Cannulation: Time to Bring Subclavian Central Lines Back. West J Emerg Med. 2016 Mar;17(2):216-21. doi: 10.5811/westjem.2016.1.29462. Epub 2016 Mar 2.

    PubMed 26973755

Questions about this trial

What is this clinical trial studying?

A study testing Agitated Saline Method and chest x-ray in people with Central Venous Catheterization and Exposure to X-Rays, run by Nepal Mediciti Hospital.

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: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Achyut Sharma, MD (+9779841266828, achyut.sharma@nepalmediciti.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of central line placement (time frame: 7 months). 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 NCT03442790, which also lists 10 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 10 Apr 2018.

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