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ThrombophlebitisCOT-cannulaNCT07182877

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

A study testing Closed-type peripheral cannula and Open type peripheral cannula in people with Thrombophlebitis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 90 years
Conditions the study is for
Thrombophlebitis
What is being tested?
Closed-type peripheral cannula and Open type peripheral cannula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIndia
Study dates
1 Oct 2025to 31 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

India1 site
  • Respiratory ICU, Department of Pulmonary Medicine, PGIMER

    Chandigarh, 160012

Other trials in India

About this study

Official 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

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

Read the 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

Being tested
Closed-type peripheral cannula, Open type peripheral cannula
Keywords
IV cannula, thrombophlebitis
Medical subject headings
Thrombophlebitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Closed-type peripheral cannulaDevice

    Also called Closed cannula

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

  • Open type peripheral cannulaDevice

    Also called Open cannula

    We will use POLYMED Ultra Intravenous cannula in the control arm

Study groups in NCT07182877
Study groupRoleWhat they receive
Group 1ExperimentalClosed-type peripheral catheters
Receives: Device: Closed-type peripheral cannula
Group 2Active comparatorOpen-type peripheral catheters
Receives: Device: Open type peripheral cannula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dwell time

    Time till cannula is used for dispensing drugs

    Measured: 28 days

  2. Dwell time

    The time for which intravenous cannula is kept for dispensing drugs

    Measured: 28 days

Secondary outcomes (1)
  1. Catheter-related complications

    Complications attributed to the intravenous cannula

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study start1 Oct 2025
  3. Primary completion1 Jan 2026
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group 1: closed-type peripheral catheters Group 2: open-type peripheral catheters
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07182877
Sponsor's protocol ID
IEC-INT/2024/Study-2393
Acronym
COT-cannula
Status last verified
Feb 2026
First submitted
13 Sep 2025
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD will be shared on reasonable request to the PI. The IPD will be shared for academic purposes and if the protocol is approved by the PI's IEC

Questions about this trial

What is this clinical trial studying?

A study testing Closed-type peripheral cannula and Open type peripheral cannula in people with Thrombophlebitis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dwell time (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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