RecruitingACTRN12617000619347

Accuracy of electrocardiogram to insert peripherally inserted central catheters (PICCs) in adult hospitalised patients

Accuracy of the Delta electrocardiogram (ECG) system to verify correct peripherally inserted central catheter (PICC) tip location in adult hospitalised patients


Sponsor

Fiona Stanley Hospital

Enrollment

120 participants

Start Date

Mar 5, 2018

Study Type

Interventional

Conditions

Summary

Peripherally Inserted Central Catheters (PICCs) are tubes inserted into the veins of patients to infuse medications, fluids and blood products. The ends of these tubes need to sit near the heart to reduce side effects. Commonly live xray (fluoroscopy) is used to make sure the PICC is at the right place. But this is expensive and difficult to coordinate. ECG tracing represents different parts of the heart working and when the PICC is placed near the heart, this tracing will change. Thus, we can see when the end of the PICC is in the correct place. But, there is limited evidence that this system is accurate compared to fluoroscopy and the cost implications are unknown. This research aims to compare the accuracy of an ECG tip verification system (Nautilus Delta) with fluoroscopy and determine the economic implications of a change in practice. Patients already undergoing PICC insertion will be recruited at Fiona Stanley Hospital. The PICC will be inserted the usual way and when the Nautilus Delta ECG system indicates it’s in the correct area, fluoroscopy will be used to verify where the tip is. Hospital and enterprise bargaining information will be used to determine the costs associated with the different systems. Hypothesis: the Nautilus Delta ECG system will be accurate when compared to fluoroscopy and more cost effective


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • All adult (18 years or older) patients booked for a single, double or triple lumen PICC insertion above the ante-cubital fossa region (usual practice) by the PICC nurse inserter in the Radiology Department.

Exclusion Criteria5

  • Inability to provide informed consent due to neurological or language barriers (diagnosis of dementia; uncontrolled mental illness or deficits; inability to read, write or understand English).
  • Participants with known cardiac arrhythmia disorders (Atrial Fibrillation, Atrial Flutter, Tachycardia) or those with Pacemakers.
  • Undetectable or abnormal P-wave on baseline ECG
  • Inability to lie flat on procedure bench
  • Participants who are pregnant

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Interventions

Peripherally Inserted Central Catheters (PICCs) are tubes inserted into the veins of patients to infuse medications, fluids and blood products. It is considered best practice for the PICC tip to termi

Peripherally Inserted Central Catheters (PICCs) are tubes inserted into the veins of patients to infuse medications, fluids and blood products. It is considered best practice for the PICC tip to terminate in a large vein near the entrance to the heart (lower third superior vena cava (SVC) or right atrium junction). Commonly, the carina (tracheal bifurcation) is used as a surrogate landmark for the commencement of the lower section of the SVC. Currently, fluoroscopy or live x-ray is used to determine PICC tip location in many hospitals, but this is costly and requires patients to travel to the Radiology department. Many hospitals in Australia and overseas use an electrocardiogram (ECG) tip verification system for PICC insertion. The ECG tracing changes as the PICC tip approaches the right atrium junction. There is limited evidence that this system is accurate compared to fluoroscopy and the cost implications are unknown. This research aims to compare the accuracy of an ECG tip verification system (Nautilus Delta) with fluoroscopy and determine the economic implications of a change in practice. Patients booked for PICC insertion, as part of their usual care will be invited to participate. Patients will be excluded if they are unable to provide informed consent, have cardiac arrhythmia disorders, abnormal P-wave (atrial fibrillation) on baseline ECG and who are pregnant. Patients will have a PICC inserted as per usual practice by the PICC inserter, an advanced practice Registered Nurse. The approximate duration of the procedure is 30 minutes. Once the tip is near the right atrium junction the PICC inserter will use the ECG trace to determine correct tip termination. Once the Nautilus Delta ECG system indicates correct PICC tip placement, fluoroscopic imaging will be performed to determine whether the tip position is in the lower third SVC or SVC/RA junction. The fluoroscopic image will be saved on the Picture Archiving and Communications System (PACS) as per usual practice. If the PICC tip location is deemed to be incorrect by the PICC inserter using fluoroscopy, the first image will be labelled as clinical trial and the PICC tip position will be adjusted. A second fluoroscopic image will be stored on PACS which will be labelled corrected tip position. An independent Medical Registrar will use inbuilt callipers to measure the distance of the PICC tip from the carina on the image stored on PACS after trial completion (solitary image or image labelled clinical trial where appropriate).


Locations(1)

Fiona Stanley Hospital - Murdoch

WA, Australia

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ACTRN12617000619347