Insertion of PICC With Intracavitary ECG Navigation

NCT ID: NCT04444479

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-10

Study Completion Date

2023-04-30

Brief Summary

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The study subjects who are indicated for peripherally inserted central (PICC) catheter placement will undergo this procedure under the control of ECG, the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.

Detailed Description

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The study subjects who are indicated for PICC catheter placement will undergo this procedure under the control of electrocardiography (ECG), the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.

Conducting this study should allow us to see the feasibility of using real-time ECG navigation, its accuracy comparing to the chest X-ray method. ´ The second goal is to eliminate chest X-ray as an obsolete method, Also the advantages and disadvantages of both methods will be assessed.

Conditions

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Long-term Venous Access

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study subjects enrolled in the study will be assigned to one study group. No randomization is performed.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

No masking will be used in the study

Study Groups

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PICC catheter placement

Study subjects in whom placement of the PICC catheter is indicated

Group Type EXPERIMENTAL

ECG verification

Intervention Type OTHER

The correct positioning of the PICC catheter tip will be verified using ECG.

X-ray verification

Intervention Type OTHER

The correct positioning of the PICC catheter tip will be verified using X-ray imaging.

Interventions

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ECG verification

The correct positioning of the PICC catheter tip will be verified using ECG.

Intervention Type OTHER

X-ray verification

The correct positioning of the PICC catheter tip will be verified using X-ray imaging.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* indication for establishing long-term venous access
* 18 years of age and over

Exclusion Criteria

* oncological patients
* non-signing the informed consent form
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Ostrava

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Iveta Constantine, Bc.,MSc.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

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University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Site Status

Countries

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Czechia

References

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Pittiruti M, La Greca A, Scoppettuolo G. The electrocardiographic method for positioning the tip of central venous catheters. J Vasc Access. 2011 Oct-Dec;12(4):280-91. doi: 10.5301/JVA.2011.8381.

Reference Type BACKGROUND
PMID: 21667458 (View on PubMed)

Bidgood C. Improving the patient experience with real-time PICC placement confirmation. Br J Nurs. 2016 May 26-Jun 8;25(10):539-43. doi: 10.12968/bjon.2016.25.10.539.

Reference Type BACKGROUND
PMID: 27231736 (View on PubMed)

Johnston AJ, Holder A, Bishop SM, See TC, Streater CT. Evaluation of the Sherlock 3CG Tip Confirmation System on peripherally inserted central catheter malposition rates. Anaesthesia. 2014 Dec;69(12):1322-30. doi: 10.1111/anae.12785. Epub 2014 Jul 10.

Reference Type BACKGROUND
PMID: 25040430 (View on PubMed)

Other Identifiers

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07/ RVO- FNOs/ 2020

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MH CZ - DRO - FNOs/2020

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PICC-07-ECG_Navigation

Identifier Type: -

Identifier Source: org_study_id

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