Agitated Saline Versus CXR Confirmation of Central Venous Lines

NCT03442790 | Unknown

• 1 other identifier: NepalMediciti
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Central Venous Catheterization; Exposure to X-Rays

Keywords

CVC confirmation; Agitated Saline; CXR

Outcome Measures

Primary Outcomes (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

  7 months

Secondary Outcomes (2)

• Compare the time required for confirmation

  7 months

• Accuracy of malposition detection

  7 months

Study Arms (2)

Agitated Saline Method

EXPERIMENTAL

The proper placement of the central venous line will be confirmed using agitated saline under ultrasound vision

Procedure: Agitated Saline Method; Procedure: chest x-ray

Chest X-Ray Confirmation

ACTIVE COMPARATOR

The proper placement of the central venous line will be compared with chest x-ray obtained in supine position after central line placement

Procedure: Agitated Saline Method; Procedure: chest x-ray

Interventions

Agitated Saline Method PROCEDURE

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.

Also known as: bubble confirmation, contrast enhanced confirmation

Agitated Saline Method; Chest X-Ray Confirmation

chest x-ray PROCEDURE

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

Also known as: CXR, supine x-ray

Agitated Saline Method; Chest X-Ray Confirmation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nepal Mediciti Hospital: lead

Related Publications (10)

• 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.

  BACKGROUND

• 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.

  PMID: 19826584 BACKGROUND

• 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.

  PMID: 18197436 BACKGROUND

• 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.

  PMID: 19881083 BACKGROUND

• 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.

  PMID: 18326129 BACKGROUND

• 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.

  PMID: 20599208 BACKGROUND

• 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.

  PMID: 27556036 BACKGROUND

• 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.

  PMID: 10389780 BACKGROUND

• 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.

  PMID: 24184012 BACKGROUND

• 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.

  PMID: 26973755 BACKGROUND

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Achyut Sharma, MD

  Nepal Mediciti Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Achyut Sharma, MD

CONTACT

+9779841266828; achyut.sharma@nepalmediciti.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participants will not have any knowledge of the intervention and the investigator who is doing the ultrasound confirmation will not have access to the results of the chest x-ray confirmation until the end of the study period when all the data is analyzed.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Anesthesia and Intensive Care

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 22, 2018
• Study Start: May 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 10, 2018

Record last verified: 2018-04