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

Catheterization, Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03592602
• Other study ID #: 26010105051802
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: July 2018
• Source: Qilu Hospital of Shandong University
• Contact: Wei Gao
• Phone: +8617753101262
• Email: gaoweisdu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 1, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheterization, Central Venous
• Catheterization, Peripheral

Intervention

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.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.