Evaluate the Impact of Arm Abduction and Adduction on the Intravascular Electrocardiograph During PICC Placement and the Tip Location Changes Related to it

NCT03592602 | Unknown

• 1 other identifier: 26010105051802
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the impact of arm abduction and adduction on the intravascular electrocardiograph during PICC placement and to find out how arm position influences the catheter tip location by taking postprocedural chest X-ray radiographs.

Conditions

Catheterization, Peripheral; Catheterization, Central Venous

Outcome Measures

Primary Outcomes (1)

• Changes of the intravenous ECG with the arm abducted and adducted during PICC placement.

  Comparing the shape and amplitude of the p wave with the arm abducted and adducted.

  Usually the procedure will take from 0-60 minutes.

Secondary Outcomes (1)

• Changes of the catheter tip position with the arm abducted and adducted.

  Usually from 0-7 days after the procedure.

Study Arms (1)

arm movement

EXPERIMENTAL

Male or female patients, age ≥ 18, who meet the indication of PICC placement and be able to move the arm (abducted and adducted) with compliance will be studied.

Procedure: arm abduction and adduction

Interventions

arm abduction and adduction PROCEDURE

All PICC lines will be placed under the guidance of intravascular ECG. Before the PICC placement procedure, basal ECG will be examed. During the procedure, intravascular ECG data will be collected with the punctured arm adduction and abduction while the catheter advances to the cavoatrial junction. After the procedure, chest X-ray radiographs will be taken with arms 90° abducted and adducted (i.e., 0°abducted) in a supine position.

arm movement

Eligibility Criteria

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

You may qualify if:

• indication for PICC placement
• able to corporate with the operator during the procedure
• a recognizable P wave on basal ECG

You may not qualify if:

• bedside PICC placement
• Atrial fibrillation or other atrial arrhythmia's in which a P wave was not consistently present on ECG.
• with pacemaker
• unable to move to take post-procedural chest X-ray radiographs
• unable to move the punctured arm or can only move with limited angles due to anatomical abnormalities or personal/medical equipment or surgeries.
• catheter tip cannot be clearly visible on chest X-ray radiograph due to thoracic abnormalities or cardiothoracic surgeries.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

RECRUITING

Central Study Contacts

Wei Gao

CONTACT

+8617753101262; gaoweisdu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: July 19, 2018
• Study Start: June 15, 2018
• Primary Completion: October 15, 2018
• Study Completion: November 1, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)