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Agitated Saline Versus CXR Confirmation of Central Venous Lines

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ClinicalTrials.gov Identifier: NCT03442790
Recruitment Status : Not yet recruiting
First Posted : February 22, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Achyut Sharma, Nepal Mediciti Hospital

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.

Condition or disease Intervention/treatment Phase
Central Venous Catheterization Exposure to X-Rays Procedure: Agitated Saline Method Procedure: chest x-ray Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: Agitated Saline Versus Chest X-ray for Determination of Correct Position of Central Venous Catheter: a Non-inferiority Study
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays

Arm Intervention/treatment
Experimental: Agitated Saline Method
The proper placement of the central venous line will be confirmed using agitated saline under ultrasound vision
Procedure: Agitated Saline Method
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.
Other Names:
  • bubble confirmation
  • contrast enhanced confirmation

Procedure: chest 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
Other Names:
  • CXR
  • supine x-ray

Active Comparator: Chest X-Ray Confirmation
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
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.
Other Names:
  • bubble confirmation
  • contrast enhanced confirmation

Procedure: chest 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
Other Names:
  • CXR
  • supine x-ray




Primary Outcome Measures :
  1. Accuracy of central line placement [ Time Frame: 7 months ]
    1. To compare the accuracy of ultrasound guided agitated saline confirmation and chest x-ray confirmation of central venous line position


Secondary Outcome Measures :
  1. Compare the time required for confirmation [ Time Frame: 7 months ]
    To compare the time required for ultrasound guided agitated saline confirmation and chest x-ray confirmation of central venous line position

  2. Accuracy of malposition detection [ Time Frame: 7 months ]
    To compare the accuracy of detection of central venous line malposition



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age <18 years
  2. Pregnant patients
  3. Patients with moderate and severe RV dysfunction
  4. Patient with moderate and severe tricuspid regurgitation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442790


Contacts
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Contact: Achyut Sharma, MD +9779841266828 achyut.sharma@nepalmediciti.com

Sponsors and Collaborators
Nepal Mediciti Hospital
Investigators
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Principal Investigator: Achyut Sharma, MD Nepal Mediciti Hospital

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.

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Responsible Party: Dr. Achyut Sharma, MD Anesthesia and Intensive Care, Nepal Mediciti Hospital
ClinicalTrials.gov Identifier: NCT03442790     History of Changes
Other Study ID Numbers: NepalMediciti
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Achyut Sharma, Nepal Mediciti Hospital:
CVC confirmation
Agitated Saline
CXR

Additional relevant MeSH terms:
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Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms