Central Venous Catheter vs Midline in Difficulty Access Patient - Pilot Trial

NCT06719869 | Completed

• 2 other identifiers: CIV-24-08-0487982024-05700-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous access is a necessity for nearly all inpatient medical care. Approximately half of hospitalized patients require a peripheral venous catheter (PVC), either to enable administration of medications intravenously or to repeatedly draw blood samples (1). Establishing a venous access sometimes requires repeated attempts, resulting in multiple needle sticks and prolonged discomfort for patients. In addition, this may lead to a diminished healthcare experience and create a stressful situation for both patients and healthcare personnel (2, 3). Delays in establishing intravenous access can result in setbacks in sample collection and drug administration (4, 5). Difficult Intravenous Access (DIVA) is a situation that arises "when two or more clinicians fail two or more times to establish a peripheral access using conventional techniques, when a patient lacks visible or palpable veins or the patient has a stated or documented history of DIVA" (6). The prevalence of DIVA varies from 6% to 88% in different studies, primarily due to variations in definition of DIVA. Known risk factors are diabetes, intravenous drug abuse, sex (higher risk for women), chronic illness, obesity, malnutrition, absence of visible or palpable veins (7, 8). Although it is possible to establish a short, standard-length PVC through the help of ultrasound-guidance, this approach has limited scientific support (4, 9-11). In addition, ultrasound-guided PVCs are not health economically justifiable (12). There are a handful of alternatives in terms of vascular access devices (VAD) for DIVA patients: Standard short PVC, Midline catheter, Central Venous Catheter (CVC) and Peripherally Inserted Central Catheter (PICC). A Midline is a long (8-12 cm), peripherally inserted venous catheter that is most commonly inserted into the upper arm via the basilic, cephalic or brachial veins, with its tip terminating below the level of the axilla (13). A Central Venous Catheter (CVC) is inserted through one of several veins (subclavian, jugular, or femoral) and terminates in a central vein, typically the superior vena cava, right atrium, or the iliac/inferior vena cava, depending on the insertion site. A PICC is an extended venous catheter inserted peripherally, similar to the Midline, inserted through the veins of the upper arm. However, the PICC terminates centrally, in the superior vena cava. There is some existing evidence supporting that Midline catheters could be safer compared to PICCs in short term (14-16). Today, CVCs are standard of care in many centers, but retrospective data indicate that Midlines could be a feasible option in DIVA patients (17). Furthermore, CVC insertion involves certain risks, such as arterial puncture, hematoma or pneumothorax (18). For DIVA patients in need of venous access for 5 days or more, Midlines are preferred as per the Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) guidelines (13). However, there are no randomized controlled clinical trials comparing Midlines to CVCs in DIVA patients. Primary aim of study The aim of the study is to test the feasibility of the study protocol before a future large-scale RCT.

Conditions

Difficult Intravenous Access

Keywords

central venous catheterization; midline; difficult intravenous access; randomised controlled trial; pilot trial

Outcome Measures

Primary Outcomes (7)

• Percentage of participants who complete all study procedures accordingly. (Feasibility)

  Feasibility is defined as the percentage of participants who complete all study procedures as per protocol. Assesed using screening logs, case report forms, follow-up logs and collected data base.

  From screening to 29 days after enrollment

• Percentage of screened patients eligible to participate. (Eligibility)

  Eligibility is defined as the percentage of screened patients who meet the inclusion criteria and are eligible to participate in the study. Assessed by screening logs and eligibility criteria checklists.

  At screening.

• Percentage of eligible patients who consent to participate. (Recruitment)

  Recruitment is defined as the percentage of eligible patients who provide informed consent to participate in the trial. Assessed by consent logs.

  At recruitment to 29 days after recruitment.

• Percentage of patients retained in the study. (Retention and attrition)

  Retention and attrition is defined as the percentage of patients retained in the study, excluding those lost to follow-up or who withdrew consent. Assessed by follow-up forms.

  From randomization to 29 days after enrollment

• Percentage of patients adhering to randomized intervention. (Adherence)

  Adherence is defined as the percentage of enrolled patients who receive their randomized intervention as per protocol. Assesed by case report forms.

  From randomization to 29 days after enrollment

• Percentage of patients with incomplete data. (Missing data)

  Missing data is defined as having less than 10% of enrolled patients' data incomplete. Assesed through case report forms and collected database.

  From randomization to 29 days after enrollment

• Percentage of patients requiring multiple venipunctures. (Venipuncture attempts)

  Venipuncture attempts are defined as the percentage of enrolled patients requiring 2 or more venipunctures per insertion. Assesed through case report forms.

  At insertion.

Secondary Outcomes (3)

• Insertion time, minutes

  At insertion

• Dwell time, days

  From randomization to 29 days after enrollment

• Number of patients with complications.

  From randomization to 29 days after enrollment

Study Arms (2)

Midline catheter

EXPERIMENTAL

Device: Midline intravenous catheter

Central venous catheter

ACTIVE COMPARATOR

Centrally inserted CVC

Device: Central Venous Catheter (CVC):

Interventions

Midline intravenous catheter DEVICE

Patients in the intervention group receive a 10 cm PowerGlide Pro™ Midline Catheter (Becton Dickinson). Catheters are inserted with ultrasound-guidance by an anesthesiologist using sterile gloves, mask, and large drape. The insertion site is treated with a solution of 0.5% chlorhexidine (wt/vol) in 70% alcohol (SCHA) and allowed to dry for 1 to 2 minutes prior to insertion. No prophylactic antibiotics are given as per default. All catheters are secured with using a StatLock™ Stabilization device (Becton Dickinson), and the site is dressed with a semipermeable dressing (Tegaderm HP; 3M Healthcare, St. Paul, MN). A red paper tag is attached to the catheter, indicating study participation. Choice of insertion site on arm below or above the elbow avoiding catheter across joints and at the clinician's discretion.

Midline catheter

Central Venous Catheter (CVC): DEVICE

Patients in the control group receive a Celsite 320 or 315 (B. Braun) or Pressure Injectable Arrowg+ard Blue Plus+ (Arrow). Catheters are inserted with ultrasound-guidance by an anesthesiologist with maximal sterile precautions (cap, mask, gown, gloves, and large drape) using the Seldinger technique. The insertion site is treated with a solution of 0.5% chlorhexidine (wt/vol) in 70% alcohol (SCHA) and allowed to dry for 1 to 2 minutes prior to insertion. No prophylactic antibiotics are given as per default. Catheters are secured with monofilament sutures, and the site is dressed with a semipermeable dressing (Tegaderm HP; 3M Healthcare, St. Paul, MN). A red paper tag is attached to the catheter, indicating study participation. The choice of insertion site is at the clinician's discretion

Central venous catheter

Eligibility Criteria

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

You may qualify if:

• Age 18 and over
• DIVA criterium fulfilled;
• attempts of venous access by 2 clinicians OR
• No visible nor palpable veins OR
• History of difficult venous access
• days of catheter dwell time anticipated as assessed by referring clinician.

You may not qualify if:

• Unable to speak Scandinavian
• Cognitive Impairment
• Is to receive hyperosmolar solutions (600 milliosmoles/L or above).
• Is to receive chemotherapy

Sponsors & Collaborators

• Region Jönköping County: lead

Study Sites (1)

Länssjukhuset Ryhov

Jönköping, Region Jönköping, Sweden

Location

MeSH Terms

Interventions

Central Venous Catheters

Intervention Hierarchy (Ancestors)

Vascular Access Devices; Catheters; Equipment and Supplies

Study Officials

• Knut Taxbro, MD, PhD

  Region Jönköping County

  PRINCIPAL INVESTIGATOR

• Stefanie Seifert, MD

  Region Jönköping County

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 6, 2024
• Study Start: January 13, 2025
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

SE (1)