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

NCT01969981 | Completed

• 2 other identifiers: SHERLOCK 3CG1626789
• Study Type: observational
• Target: 571
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Intravenous

Keywords

Peripheral Inserted Central Catheter

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

• Assess the number of punctures in brachial site

  During the procedure (Day 0)

• Assess the unique punction rate

  During the procedure (Day 0)

• Assess the number of repositions after procedure closed

  During the procedure (Day 0)

• Assess pain

  During the procedure (Day 0)

• Assess acute complications rate

  During the procedure (Day 0)

Study Arms (1)

PICC placement

Procedure: PICC placement with Sherlock 3CG

Interventions

PICC placement with Sherlock 3CG PROCEDURE

PICC placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be included as well as they are ambulatory or hospitalized in Centre Leon Berard.

You may qualify if:

• 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.

You may not qualify if:

• 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…

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Leon Berard

Lyon, 69008, France

Location

MeSH Terms

Interventions

Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Hervé ROSAY, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 25, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

FR (1)