Insertion of PICC With Intracavitary ECG Navigation

• Sponsor: University Hospital Ostrava (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04444479
• Collaborator: (none)
• Enrollment: 450
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 33.7
• Patients Per Site Per Month: 13.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Long-term Venous Access	Other: ECG verification; Other: X-ray verification	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 450 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The study subjects enrolled in the study will be assigned to one study group. No randomization is performed.The study subjects enrolled in the study will be assigned to one study group. No randomization is performed.
• Masking: None (Open Label)
• Masking Description: No masking will be used in the study
• Primary Purpose: Other
• Official Title: PICC Insertion With the Use of IC ECG Navigation to Confirm the PICC Tip Location Compare to Chest X-ray
• Actual Study Start Date: Jun 10, 2020
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PICC catheter placement Study subjects in whom placement of the PICC catheter is indicated	Other: ECG verification; The correct positioning of the PICC catheter tip will be verified using ECG.; Other: X-ray verification; The correct positioning of the PICC catheter tip will be verified using X-ray imaging.

Outcome Measures

Primary Outcome Measures

1. Time interval between ECG and X-ray [2 hours]

   The time elapsed between performing the ECG examination and the X-ray examination will be measured in minutes.

Secondary Outcome Measures

1. Success-rate of correct PICC tip location [2 hours]

   The success-rate of correct PICC tip location will be determined using ECG navigation against the use of chest X-ray, and expressed as distance in centimetres from the target point.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ostrava	Ostrava	Moravian-Silesian Region	Czechia	70852

Sponsors and Collaborators

• University Hospital Ostrava

Investigators

• Principal Investigator: Iveta Constantine, Bc.,MSc., University Hospital Ostrava

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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. Review.

• Responsible Party: University Hospital Ostrava
• ClinicalTrials.gov Identifier: NCT04444479
• Other Study ID Numbers: PICC-07-ECG_Navigation; 07/ RVO- FNOs/ 2020; MH CZ - DRO - FNOs/2020
• First Posted: Jun 23, 2020
• Last Update Posted: Jun 25, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital Ostrava: peripherally inserted central catheter; ECG navigation; chest x-ray; PICC tip navigation; catheter tip location; intracavitary ECG

Study Results

No Results Posted as of Jun 25, 2020