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Completed

NCT Number: NCT07182877

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

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

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Key information

Age range

12 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory ICU, Department of Pulmonary Medicine, PGIMER

Chandigarh, 160012, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Closed-type peripheral cannula

Device

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

Other names: Closed cannula

Open type peripheral cannula

Device

We will use POLYMED Ultra Intravenous cannula in the control arm

Other names: Open cannula

Primary outcomes

  1. Dwell time

    Time frame: 28 days

    Time till cannula is used for dispensing drugs

  2. Dwell time

    Time frame: 28 days

    The time for which intravenous cannula is kept for dispensing drugs

Secondary outcomes

  1. Catheter-related complications

    Time frame: 28 days

    Complications attributed to the intravenous cannula

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

A Randomized Controlled Trial to Compare the Dwell Time of Open and Closed-type Peripheral Catheters in Patients Admitted to the Respiratory Intensive Care Unit

Acronym: COT-cannula

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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