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Status unknownNCT03592602Updated Jul 19, 2018

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

An interventional study of arm abduction and adduction in Catheterization, Peripheral and Catheterization, Central Venous, sponsored by Qilu Hospital of Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Catheterization, Peripheral
  • Catheterization, Central Venous
03

In context

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • 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

Interventions

  • Procedurearm 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.

06

What researchers measure

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.

    Time frame: Usually the procedure will take from 0-60 minutes.

Secondary outcomes

  1. 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.

    Time frame: Usually from 0-7 days after the procedure.

07

Study locations

1 of 1 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03592602
Lead sponsor
Qilu Hospital of Shandong University
Responsible party
Sponsor
First posted
Jul 19, 2018
Start date
Jun 15, 2018
Primary completion
Oct 15, 2018 (estimated)
Completion
Nov 1, 2018 (estimated)
Last update
Jul 19, 2018

Study contacts

Wei Gao
Contact
gaoweisdu@163.com
+8617753101262

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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