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Central line placement in critically ill children: ultrasound versus landmark

Efficacy and safety of central venous catheter placement in the internal jugular vein, using the ultrasound-guided technique versus the anatomical landmark technique, in critically ill pediatric patients: Randomized clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45566499
Enrollment
98
Registered
2026-06-12
Start date
2019-09-12
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Central venous catheter placement in critically ill paediatric patients: ultrasound-guided versus anatomical landmark technique guided internal jugular vein catheterisation. Other

Interventions

A randomised, controlled, single-blind clinical trial in paediatric patients (aged 1 month to 15 years and 11 months) admitted to the Paediatric Intensive Care Unit (PICU) at UMAE No. 48, León, Mexico
catheter size according to age/weight (infants 4 Fr
2–6 years 4–5 Fr
6–10 years 5–7 Fr
>10 years 7 Fr). Anatomical landmark technique placement (ALT, control): classic Seldinger approach using anatomical landmarks with the patient in the Trendelenburg position. The procedure consists o
the lumens were flushed with heparinised saline (100 IU/100 mL) according to local protocol. Failure was defined as failure to achieve cannulation after 4 attempts or the occurrence of a major complic
the final position of the catheter was confirmed by chest X-ray or echocardiography. Randomisation: 1:1 allocation by coin toss at the time of the procedure
the study was single blind (operators were unblinded
outcome assessors and the statistical analyst were blinded via data coding). Planned sample size 98 (49 per group)
73 patients recruited
the trial was stopped early on the recommendation of the independent committee following an interim analysis due to evidence of superior efficacy of TGUS.

Sponsors

Mexican Social Security Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 15 Years

Inclusion criteria

Inclusion criteria: 1. Age: between 1 month and 15 years and 11 months at the time of the procedure 2. Admission: to be hospitalised in the Paediatric Intensive Care Unit (PICU) of UMAE No. 48, Hospital Gineco Pediatria 3. Clinical indication: requires placement of a central venous catheter (CVC) according to medical criteria 4. Gender: any gender (no restriction)

Exclusion criteria

Exclusion criteria: 1. Haematological malignancies with active coagulation disorders, defined by any of the following: prothrombin time greater than 18 seconds; activated partial thromboplastin time (aPTT) greater than 55 seconds. or platelet count less than 50 × 10?/L. 2. Ongoing anticoagulant therapy 3. Malformation at the puncture site preventing the procedure 4. Legal guardian not providing informed consent 5. Incomplete medical records preventing the collection of essential data 6. Incomplete procedure data on the data collection form 7. Voluntary discharge of the patient before completion of the protocol 8. Withdrawal from the protocol by decision of the legal guardian 9. Transfer to another hospital unit preventing follow-up and evaluation of results

Countries

Mexico

Contacts

Public ContactIsrael Moreno
medicinacriticapedimssbajio@gmail.com+1 52 477 7174800, +1 52 477 2525628

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 29, 2026