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A Study Comparing the Ease and Safety of Two Types of Long Intravenous Lines Used During Surgery

Evaluation of Perioperative Usability of a Triple-Lumen Central Venous Catheter Used as a Midline Device versus Standard Central Venous Cannulation: A Prospective, Randomised Controlled Non-Inferiority Trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105908
Enrollment
110
Registered
2026-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Health Condition 1: PCS-

Interventions

Intervention1: Triple-lumen central venous catheter used as midline device: Peripheral upper arm vein (ultrasound-guided) Insertion of a 7 Fr triple-lumen central venous catheter into a large upper-ar

Sponsors

All India Institute of Medical Sciences (AIIMS)New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Adult patients greater than or equal to 18 years. b) Adult patients undergoing major surgeries requiring insertion of central venous cannulation for peri operative use.

Exclusion criteria

Exclusion criteria: a) Patients with thrombocytopenia or coagulopathy b) Preexisting venous thrombosis or known hypercoagulable state. c) BMI greater than 40 kg per meter square d) Neurovascular condition involving the upper extremity. e) Local site infection or inflammation. f) Kidney disease requiring vein preservation g) Patient requiring intra-operative CVP monitoring

Design outcomes

Primary

MeasureTime frame
Proportion of patients with a usable catheter at 72 hours. Catheter usability defined as meeting all the following criteria: Absence of local redness, induration, tenderness, pus point. Ability to administer medicines through all three ports without peri-port leakage. Ability to aspirate blood for sampling. Absence of any sign for venous thrombosis (pain and asymmetrical edema of ipsilateral limb)Timepoint: Proportion of patients with a usable catheter at 72 hours. Catheter usability defined as meeting all the following criteria: Absence of local redness, induration, tenderness, pus point. Ability to administer medicines through all three ports without peri-port leakage. Ability to aspirate blood for sampling. Absence of any sign for venous thrombosis (pain and asymmetrical edema of ipsilateral limb)

Secondary

MeasureTime frame
Insertion time (time of skin prick to aspiration of blood from any of the ports). 1st attempt success rate (one attempt defined as proportion of catheter insertions successfully completed on the very first needle puncture or venipuncture without requiring additional punctures, needle redirections, or catheter reinsertion attempts) Insertion site complications. Blood culture positivity at 72 hours. Incidence of nerve injury (paraesthesia or paresis of the ipsilateral arm)Timepoint: Insertion time Measured from skin prick to first successful blood aspiration from any port During procedure (intraoperative) First-attempt success rate Documented during cannulation success if completed without additional punctures/needle redirection/catheter reinsertion During procedure (intraoperative) Insertion site complications Clinical examination for bleeding, hematoma, arterial puncture, malposition, pain Immediately post-procedure and daily till 72 hours (Day 1, Day 2, Day 3) Blood culture positivity 10 ml blood aspirated from catheter port for culture At 72 hours post-surgery Incidence of nerve injury Clinical evaluation of paraesthesia/weakness of ipsilateral arm Daily assessment till 72 hours (Day 1, Day 2, Day 3) and earlier if symptoms appear

Countries

India

Contacts

Public ContactShreya Inamdar

All India Institute of Medical Sciences (AIIMS) New Delhi

vimirewari@gmail.com9818304880

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026