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

Anesthesia Clinical Trial

— SHERLOCK 3CG  

Official title:

An Observational, Prospective, Single-center Study of Placement and Confirmation of Peripheral Inserted Central Catheters Tip Position Using a New Electrocardiographic Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969981
• Other study ID #: SHERLOCK 3CG
• Secondary ID: 1626789
• Status: Completed
• Phase: N/A
• First received: October 22, 2013
• Last updated: September 11, 2014
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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…

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia
• Intravenous

Intervention

Procedure:
• PICC placement with Sherlock 3CG

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of PICC placement using the Sherlock 3CG	Success rate of PICC placement (no need to use radiation or fluoroscopy before the end of the procedure)	During the procedure (Day 0)	No
Secondary	Assess the number of punctures in brachial site	Efficacy of needle guide	During the procedure (Day 0)	No
Secondary	Assess the unique punction rate		During the procedure (Day 0)	No
Secondary	Assess the number of repositions after procedure closed		During the procedure (Day 0)	No
Secondary	Assess pain	By means of a Verbal Numeric Scale	During the procedure (Day 0)	No
Secondary	Assess acute complications rate	Hemothorax, arterial puncture, etc.	During the procedure (Day 0)	Yes
Secondary	Assess the percentage of patients requiring fluoroscopy		During the procedure (Day 0)	No
Secondary	Assess the final radiation rate	When applicable	During the procedure (Day 0)	No
Secondary	Assess the percentage of patients with good placement on the X-Ray		During the procedure (Day 0)	No