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

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.

Study Overview

• Status: Unknown
• Conditions: Catheterization, Peripheral; Catheterization, Central Venous
• Intervention / Treatment: Procedure: arm abduction and adduction

Detailed Description

PICC has been widely applied for therapeutic and nutritional use. In the routine procedure of PICC placement, for better exposure of the punctured vein and a wider aseptic area, the PICC set is investigated with the patient's arm abducted in a supine position. While in actual use of the PICC line, patients commonly prefer a more comfortable position with arm adducted. Considering the incorporation of the arm position when the catheter is placed and being used, the effectiveness and safety of the PICC line with the punctured arm adducted are of practical importance.

This study aims to evaluate the impact of arm abduction and adduction on the intravascular electrocardiograph (ECG) during ECG-guided PICC placement and to explore how arm movement (from abduction to adduction) makes an influence on the catheter tip position.

This study is expected to enroll 150 participants. All participants would undergo the procedure of ECG-guided PICC placement. ECG data will be recorded before the procedure (basal ECG) and during the procedure with the punctured arm abducted and adducted. After the procedure, participants will take a post chest X-ray confirmation with arms adducted and abducted in a supine position. The catheter tip position and influences of arm movements will be calculated by the distances from the catheter tip to the carina on radiographs.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Gao; Phone Number: +8617753101262; Email: gaoweisdu@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Wei Gao; Email: gaoweisdu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: arm movement; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of the catheter tip position with the arm abducted and adducted.	Each patient will take two chest X-ray graphs with arms abducted and adducted respectively. Measuring distances from the catheter tip to the carina on radiographs.	Usually from 0-7 days after the procedure.

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Anticipated): October 15, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: July 1, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 26010105051802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No