Evaluation of Central Jugular Vein Catheter Lumen Holder Design and Ergonomic Use (CJVClumen)

The aim of this study was to evaluate the design and ergonomic use of central jugular vein catheter lumen holder.

Study Overview

• Status: Not yet recruiting
• Conditions: Central Venous Catheterization
• Intervention / Treatment: Other: Central Jugular Vein Catheter Lumen Holder Apparatus

Detailed Description

Central venous catheterisation is one of the invasive procedures commonly used in the treatment and care of patients in internal and surgical clinics and generally in intensive care units and in the follow-up of patients to be operated. Central venous catheters (CVC) are indispensable diagnostic and therapeutic applications in modern medicine. It is a practical method used in cases where venous vessels cannot be used.

Central venous catheterisation is a cannula inserted into the subclavian, jugular or femoral vein. Nurses are responsible for the care and daily control of central venous catheters inserted by physicians. Central venous catheterisation is widely used by nurses in clinical wards, intensive care units and during surgical procedures for many indications such as monitoring, drug administration and parenteral nutrition. Subclavian vein and jugular vein are most commonly used for this purpose. Many complications such as haemothorax, pneumothorax, malposition, air embolism and infection may develop during CVC applications. The role of the nurse is very important in the determination of CVC complications.

In terms of the individual with a central vein catheter, it constitutes a situation where the individual is worried about a catheter placed in his/her body and needs to be sensitive to the area where it is placed. They should be careful while performing daily life activities with the catheter. The presence of the central jugular vein catheter in the neck area affects the head position, and the sagging of the catheter lumens on the dressing causes skin sensitivity.

Individuals with central jugular vein catheters experience some problems such as discomfort due to sagging of the catheter lumens, inability to move comfortably in head and neck movements and sagging of the catheter lumens. The aim of this study was to develop an innovative design of central jugular vein catheter lumen holder to ensure the position, fixation and comfort efficiency of the central jugular vein catheter and to evaluate its ergonomic use.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Being a healthy individual over the age of 18
• Not having had a central jugular vein catheter inserted before for any reason (no experience)
• Being literate
• Voluntarily agreeing to participate in the research
• Being able to carry out daily life activities individually

Exclusion Criteria:

• Leaving work voluntarily
• Limitation in the head and neck area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention-control group; Participants assigned to the intervention-control group of the study performed activities using the central jugular vein catheter lumen retainer apparatus.	Other: Central Jugular Vein Catheter Lumen Holder Apparatus; Participants will experience the central jugular vein catheter lumen holder apparatus, perform walking, sitting, supine, right and left side lying activities and fill out the evaluation forms prepared by the researcher. They will then experience the same activities without the apparatus.
No Intervention: control-intervention group; Participants in the control-intervention group first performed the activities without the central jugular vein catheter lumen retainer apparatus, and then performed the activities with the apparatus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
demographic information	Contains participant identifying information	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comfort effect	The participant's comfort level is evaluated with Visual Analog Scale.	30 minutes

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Estimated): April 19, 2024
• Primary Completion (Estimated): May 16, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Nursing Research; Design, Equipment; Central Venous Catheterizations
• Other Study ID Numbers: sbughfyaseminozkan1985

Drug and device information, study documents

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