NCT07182877

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

September 13, 2025

Last Update Submit

February 16, 2026

Conditions

Keywords

IV cannula, thrombophlebitis

Outcome Measures

Primary Outcomes (2)

  • Dwell time

    Time till cannula is used for dispensing drugs

    28 days

  • Dwell time

    The time for which intravenous cannula is kept for dispensing drugs

    28 days

Secondary Outcomes (1)

  • Catheter-related complications

    28 days

Study Arms (2)

Group 1

EXPERIMENTAL

Closed-type peripheral catheters

Device: Closed-type peripheral cannula

Group 2

ACTIVE COMPARATOR

Open-type peripheral catheters

Device: Open type peripheral cannula

Interventions

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

Also known as: Closed cannula
Group 1

We will use POLYMED Ultra Intravenous cannula in the control arm

Also known as: Open cannula
Group 2

Eligibility Criteria

Age12 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory ICU, Department of Pulmonary Medicine, PGIMER

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Thrombophlebitis

Condition Hierarchy (Ancestors)

Venous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPhlebitisPeripheral Vascular DiseasesVasculitis

Study Officials

  • Inderpaul S Sehgal, DM

    PGIMER, Chandigarh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group 1: closed-type peripheral catheters Group 2: open-type peripheral catheters
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2025

First Posted

September 19, 2025

Study Start

October 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 31, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations