A Study to Assess Placement and Confirmation of Peripheral Inserted Central Catheters Tip Position Using a New Electrocardiographic Method

NCT ID: NCT01969981

Last Updated: 2014-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 571 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-04-30

Brief Summary

This is a prospective, single center, observational study. Patients who require a Peripheral Inserted Central Catheters (PICC) will constitute the study population.

The purpose of the study is to determine whether Sherlock 3CG, is adequate means for the total placement of PICC and confirmation of tip of PICC placement and if this method can be conducted safely and efficiently.

Patients will be included during a 6-month period as well as they are ambulatory or hospitalized. The patient's routine care will not be modified and only PICC will be assessed in the present study.

PICC placement will be performed using the Site Rite guidance and tip position will be confirmed using the Sherlock 3CG.

The procedure is the same as the routine habits of the operator (nurse or anesthesiologist); the vascular access team already uses the previous device for CVC placement.

Patients won't be followed up in the study.

Detailed Description

Our current Central Venous Catheter placement protocol for PICC includes the resort to UltraSonography (US) and requires fluoroscopy and plain radiographies throughout the PICC insertion and until the confirmation of best placement.

This verification is mandatory to avoid the risks, delays and costs of repositioning the tip, but obtaining a fluoroscopy and plain radiographies in operating rooms can be time consuming and exposes the patient, nurses and physicians to radiations.

The use of endocavitary electrocardiogram for tip position confirmation has been developed since 1985 and is now recognized as an alternative method. It has been recognized as the best technique in other indications, such as hemodialysis. It helps to position PICC tip in proximity to the cavoatrial junction. In Europe, Italian and German teams already use this new method.

A new ultrasound machine offering external sensors and Endocavitary ECG guide is now available (Site Rite and Sherlock 3CG - Tip Confirmation System), which allows the installation and proper placement in the same operation. This Sherlock 3CG TCS has already been approved by the Food and Drug Administration in the US and is indicated for PICC tip placement confirmation in adult patients.

This new ECG guidance method will allow the PICC insertion without any radiation in the operating room.

For the moment, according to the local recommendations, French patients will have to continue to perform one post-procedural X-ray to confirm tip position. This exam will be performed in a dedicated room of the radiology unit. But guidance and confirmation of CVC placement only by ECG may provide a faster means of confirmation and eliminates radiation exposure to the patients, nurses and anesthesiologists.

In addition, it would eliminate the costs associated with confirmatory chest X-ray (exam costs and time consumption).

Conditions

Anesthesia; Intravenous

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PICC placement

PICC placement with Sherlock 3CG

Intervention Type: PROCEDURE

Interventions

PICC placement with Sherlock 3CG

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18 years-old patient or older,
• Patient requiring PICC placement in the vascular access unit,
• Patient able to read and understand the French language,
• Patient affiliated with a social security system.

Exclusion Criteria

• Any contraindication to PICC insertion,
• Patient unable to lie in the supine position
• Patient with a Body Mass Index > 40
• Any medical condition that could change the normal presentation of the P-wave such as arrhythmia, atrial flutter, pace maker with permanent stimulation…

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hervé ROSAY, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Centre Leon Berard

Lyon, , France

Countries

France

Other Identifiers

1626789

Identifier Type: OTHER

Identifier Source: secondary_id

SHERLOCK 3CG

Identifier Type: -

Identifier Source: org_study_id