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Completed

NCT Number: NCT01969981

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Leon Berard

Lyon, 69008, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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…

Treatment and study plan

PICC placement with Sherlock 3CG

Procedure

Primary outcomes

  1. Efficacy of PICC placement using the Sherlock 3CG

    Time frame: During the procedure (Day 0)

    Success rate of PICC placement (no need to use radiation or fluoroscopy before the end of the procedure)

Secondary outcomes

  1. Assess the number of punctures in brachial site

    Time frame: During the procedure (Day 0)

    Efficacy of needle guide

  2. Assess the unique punction rate

    Time frame: During the procedure (Day 0)

  3. Assess the number of repositions after procedure closed

    Time frame: During the procedure (Day 0)

  4. Assess pain

    Time frame: During the procedure (Day 0)

    By means of a Verbal Numeric Scale

  5. Assess acute complications rate

    Time frame: During the procedure (Day 0)

    Hemothorax, arterial puncture, etc.

  6. Assess the percentage of patients requiring fluoroscopy

    Time frame: During the procedure (Day 0)

  7. Assess the final radiation rate

    Time frame: During the procedure (Day 0)

    When applicable

  8. Assess the percentage of patients with good placement on the X-Ray

    Time frame: During the procedure (Day 0)

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

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

Acronym: SHERLOCK 3CG

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 25, 2013
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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