Comparison of Dwell Time of Open Versus Closed Type Peripheral Intravenous Cannula

NCT ID: NCT07182877

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-01-31

Brief Summary

Studies have shown that stabilisation devices are associated with fewer complications and lower failure rates in peripheral catheters.3,6,7 Although closed-system peripheral catheters offer potential advantages, such as reduced manipulation of components and minimised blood spillage, more research is needed to understand their impact on outcomes. The ability of peripheral catheters to remain functional and in place without complications is crucial. While various clinical factors influence peripheral catheter performance, the composition and structure of peripheral catheters also affect their dwell time, which is defined as the duration at which the catheter remains functional after insertion. A study by McNeill et al. found that during the preintervention phase, about 62% of open-system peripheral catheters lost IV access within 36 hours, with less than 10% remaining functional beyond 72 hours. The dwell time of closed-system peripheral catheters with a securement device increased to up to 96 hours during the intervention period.8

Detailed Description

Peripheral catheters are the most frequently used medical devices in acute care settings, primarily for intravenous medication, fluid, and blood administration.1 However, their use is linked to various complications and risks, such as phlebitis, pain, infiltration, hematoma, occlusion, and more severe issues like bacteremia and sepsis.2 Studies indicate that the failure rate of peripheral catheters ranges between 35% and 50%, often due to dislodgment, infiltration, and other factors.2 These failures can lead to repeated venipunctures, increasing the risk of infection, pain, and potential damage to veins, all of which can impact patient comfort.

Advancements in the design and materials of peripheral catheters have improved their safety and comfort over time. These improvements include developing materials better suited for extended venous dwell time, mechanisms to prevent needle-related injuries, and securement devices, extension sets, stopcocks, and hubs. 3 The equipment needed for catheter insertion and maintenance varies, often consisting of multiple components that must be connected either before or after insertion. However, the manipulation of these components can introduce several issues. For instance, breaches in aseptic technique during this process can lead to the introduction of microbes into the patient's bloodstream, potentially causing insertion-related bacteremia. Previous studies have shown that Staphylococcus aureus is present in 7.6% to 23.5% of such cases.4,5 Catheter movement during manipulation can also result in dislodgment and loss of venous access. 3 One type of peripheral catheter, known as an open system, features a hub with an open end. These systems require additional components to complete the IV circuit, some of which are packaged separately. In open-system catheters, blood can flow out of the cannula and the open hub during venous access, leading to blood spillage and potential contamination. To address this, newer open-system catheters include features to prevent blood flow out of the hub after insertion, reducing the risk of blood spillage.

Another type of peripheral catheter is the closed system, which integrates an extension tube that contains blood flow within the circuit during cannulation. This design helps prevent blood spillage and needle-stick injuries. Closed-system peripheral catheters are self-contained units that do not require additional components for the IV circuit, reducing common points of contamination. Some closed-system peripheral catheters also include an integrated stabilisation platform to secure the catheter's position, which may help prevent dislodgment or injury to the vein.

Studies have shown that stabilisation devices are associated with fewer complications and lower failure rates in peripheral catheters.3,6,7 Although closed-system peripheral catheters offer potential advantages, such as reduced manipulation of components and minimised blood spillage, more research is needed to understand their impact on outcomes. The ability of peripheral catheters to remain functional and in place without complications is crucial. While various clinical factors influence peripheral catheter performance, the composition and structure of peripheral catheters also affect their dwell time, which is defined as the duration at which the catheter remains functional after insertion. A study by McNeill et al. found that during the preintervention phase, about 62% of open-system peripheral catheters lost IV access within 36 hours, with less than 10% remaining functional beyond 72 hours. The dwell time of closed-system peripheral catheters with a securement device increased to up to 96 hours during the intervention period.8

Conditions

Comparison of Dwell Time of Two Different Types of Intravenous Cannula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Closed-type peripheral catheters

Group Type: EXPERIMENTAL

Closed-type peripheral cannula

Intervention Type: DEVICE

We will use closed-type peripheral catheters (BD Nexia Closed IV Catheter System.

Group 2

Open-type peripheral catheters

Group Type: ACTIVE_COMPARATOR

Open type peripheral cannula

Intervention Type: DEVICE

We will use POLYMED Ultra Intravenous cannula in the control arm

Interventions

Closed-type peripheral cannula

We will use closed-type peripheral catheters (BD Nexia Closed IV Catheter System.

Intervention Type: DEVICE

Open type peripheral cannula

We will use POLYMED Ultra Intravenous cannula in the control arm

Intervention Type: DEVICE

Other Intervention Names

Closed cannula; Open cannula

Eligibility Criteria

Inclusion Criteria

1. All patients admitted to the intensive care unit and requiring intravenous cannulation for dispensing drugs

Exclusion Criteria

1. Patients with peripheral catheters inserted elsewhere before RICU admission 2 . Central venous catheters or other central vascular access devices 3. those with RICU stay < 24 hours will be excluded from the study 4. Pregnancy

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Inderpaul singh

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inderpaul S Sehgal, DM

Role: PRINCIPAL_INVESTIGATOR

PGIMER, Chandigarh

Central Contacts

Inderpaul S Sehgal, DM

Role: CONTACT

inderpgi@outlook.com

+91722756823

Other Identifiers

IEC-INT/2024/Study-2393

Identifier Type: -

Identifier Source: org_study_id