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Comparative safety and durability of ETFE versus FEP material based intravenous cannulas among adult patients requiring intravenous cannulation

A Randomized Controlled Trial Comparing the Safety and Functional Longevity of ETFE and FEP Peripheral Intravenous Cannulas in Adult Patients (ETFE-FEP Trial). - ETFE-FEP Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109496
Enrollment
218
Registered
2026-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z452- Encounter for adjustment and management of vascular access device

Interventions

Intervention1: ETFE based i.v. cannula: ETFE based intravenous cannula (till the patient require therapy/till the cannula needs to be replaced on medical grounds e.g. thrombophlebitis) Control Interve

Sponsors

Self
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A)Adult Patients more than 18 years will be admitted to elective General Surgery and Ophthalmology units with PIVCs (peripheral intravenous cannulation) B)Cannulation will be performed on the dorsum of the hand of 20 gauge peripheral intravenous cannula C)Presence of visible and palpable peripheral veins will be suitable for cannulation on clinical assessment D)A peripheral IV Cannula will be inserted for the first time during the current admission E)Cannula will be inserted by the trained Nursing officer, followed by fixation using a transparent, self-adhesive dressing for both groups F)All participants have to give written, informed consent before participation in the study

Exclusion criteria

Exclusion criteria: A. Patients have a current bloodstream infection B. Planned PIVC removal within 24 hours C. Intravenous catheter already in situ at the proposed insertion site D. Known hypersensitivity to cannula materials E. Existing local infection, thrombophlebitis, or skin lesions at the proposed insertion site F. Patients requiring central venous access at baseline G. Patient who has any incision or scar tissue in the IV area

Design outcomes

Primary

MeasureTime frame
To compare the functional longevity of two type of IV cannulaTimepoint: Patient will be evaluated every 8 hour till the occurrence of any cannula related thrombophlebitis/ complication.

Secondary

MeasureTime frame
A)To compare the total number of cannula required till completion of therapy. B)To compare & characterize the Device dysfunction rates of the two devices (characterization of device will be done on unused cannulas in vitro) C)To compare the Catheter-related blood stream infection between the two cannula D)To compare the all-cause bloodstream infection between the two cannula E)To compare the Infiltration rate between the two cannula F)To compare the Catheter occlusion or blockage rate between the two cannula G)To compare the number of catheter re-sites per participant per cannula H)To compare the local complication rates between the two cannula I)Cost of cannula during treatment periodTimepoint: Patient will be evaluated every 8 hour till the occurrence of any cannula related thrombophlebitis/ complication.

Countries

India

Contacts

Public ContactDr Phulen Sarma

AIIMS - Guwahati

phulen10@gmail.com8728830834

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026