A randomized controlled trial of manual compression of external iliac vein to facilitate femoral central line insertion in infants

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20221111006

Enrollment

206

Registered

2022-11-11

Start date

2022-11-25

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Pediatric intensive care unit patients Femoral central venous catheter insertion Central venous catheter Femoral vein Iliac vein Infant

Interventions

Assistant provides manual compression of ipsilateral external iliac vein above groin during ultrasound-guided femoral central venous catheter insertion by the operator.,Usual method of femoral vein ca

Experimental Procedure/Surgery,Active Comparator Procedure/Surgery

External iliac vein compression,Control

Eligibility

Sex/Gender

All

Age

No minimum to 12 Months

Inclusion criteria

Inclusion criteria: 1. Patients admitted to pediatric intensive care unit or neonatal intensive care unit, 2. Age less than 1 year old, 3. Postmenstrual age at least 37 weeks, 4. Physician in charge decides to insert femoral central venous catheter, 5. Designated operator in this study is available to perform the procedure

Exclusion criteria

Exclusion criteria: 1. Unstable vital signs or oxygen saturation, 2. Known iliac or femoral vein thrombosis or occlusion, 3. Previously enrolled into this study

Design outcomes

Primary

Measure	Time frame
First-attempt success rate During femoral central venous catheter insertion Counting needle puncture attempt	—

Secondary

Measure	Time frame
First-3-attempt success rate During femoral central venous catheter insertion Counting needle puncture attempt,Eventual success rate During femoral central venous catheter insertion Ability to percutaneously insert a central venous catheter in the initially planned side of the FV regardless of number of attempts,Number of attempts (in successful cases) During femoral central venous catheter insertion Counting needle puncture attempt,Time to successful CVC insertion During femoral central venous catheter insertion Time from first introducer needle puncture to the ability to draw free flowing blood from the inserted CVC	—

Measure

Time frame

First-3-attempt success rate During femoral central venous catheter insertion Counting needle puncture attempt,Eventual success rate During femoral central venous catheter insertion Ability to percutaneously insert a central venous catheter in the initially planned side of the FV regardless of number of attempts,Number of attempts (in successful cases) During femoral central venous catheter insertion Counting needle puncture attempt,Time to successful CVC insertion During femoral central venous catheter insertion Time from first introducer needle puncture to the ability to draw free flowing blood from the inserted CVC

—

Countries

Thailand

Contacts

Public ContactSuvikrom Law

Faculty of Medicine Siriraj Hospital, Mahidol University

suvikrom.law@mahidol.ac.th6624195673

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026