Central line placement in critically ill children: ultrasound versus landmark
| ISRCTN | ISRCTN45566499 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45566499 |
| Sponsor | Mexican Social Security Institute |
| Funder | Instituto Mexicano del Seguro Social |
- Submission date
- 18/05/2026
- Registration date
- 12/06/2026
- Last edited
- 12/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The placement of a central venous catheter (CVC) in critically ill children can be technically challenging and carries a risk of complications. The study compares two techniques for inserting a CVC into the internal jugular vein: the ultrasound-guided technique (TGUS) and the anatomical landmark technique (ALT), to determine which is more effective and safer.
Who can participate?
Children aged between 1 month and 15 years 11 months who are admitted to the Paediatric Intensive Care Unit (PICU) and require placement of a central venous catheter (CVC) in the internal jugular vein (IJV).
What does the study involve?
Interventions being compared:
TGUS (intervention): real-time ultrasound-guided central venous catheter (CVC) insertion using a linear transducer; Seldinger technique; catheters selected according to age/weight.
ALT (control): insertion using the anatomical landmarks technique (Trendelenburg position, identification of landmarks) using the Seldinger technique.
Procedure: a single placement attempt per patient (with up to 4 attempts permitted before declaring failure); sedation/analgesia according to protocol; confirmation of catheter position by chest X-ray or echocardiography.
Randomisation: 1:1 allocation by coin toss at the time of the procedure.
Blinding: single-blind study: outcome assessors and the statistical analyst remain blinded; operators are aware of the technique used.
Duration of follow-up: monitoring during hospitalisation and until catheter removal to detect
complications.
What are the possible benefits and risks of participating?
Potential benefits: a better insertion technique (if TGUS proves to be superior) may increase the likelihood of success in fewer attempts, reduce the duration of the procedure and minimise minor complications; it contributes to knowledge that may improve care for other children.
• Potential risks: complications associated with central venous catheter (CVC) placement, which may be immediate (e.g. arterial puncture, haematoma, pneumothorax), intermediate or delayed (e.g. catheter-related infection). The protocol includes safety measures, standardised procedures and imaging confirmation to minimise risks.
Where is the study run from?
The Paediatric Intensive Care Unit (PICU) at UMAE No. 48, the Gynaecology and Paediatrics Hospital, part of the Bajío National Medical Centre, in León, Guanajuato, Mexico.
When is the study starting and how long is it expected to run for?
June 2019 to August 2020.
Who is funding the study?
There was no external funding; the procedure was carried out using the hospital’s own resources.
Who is the main contact?
Gloria Patricia Sosa-Bustamante, gloria.sosa@imss.gob.mx
Contact information
Principal investigator
Department of Education and Health Research, IMSS UMAE 48, Paseo de los Insurgentes S/N, Los Paraísos
León, Guanajuato
37328
Mexico
 ORCID ID |
0000-0002-8460-4965 |
|---|---|
| Phone | +1 52 4443931426, +1 52 477 7174800 |
| gloria.sosa@imss.gob.mx |
Scientific, Public
Department of Education and Health Research, IMSS UMAE 48, Paseo de los Insurgentes S/N, Los Paraísos
León, Guanajuato
37328
Mexico
| ORCID ID |
0009-0003-9187-2540 |
|---|---|
| Phone | +1 52 477 7174800, +1 52 477 2525628 |
| medicinacriticapedimssbajio@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Participant information sheet | 49556 Participant_Information_and_Informed_Consent.pdf |
| Scientific title | 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. |
| Study acronym | Central Line In Children — Ultrasound vs Landmark |
| Study objectives | GENERAL OBJECTIVE To assess the 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 paediatric patients. SPECIFIC OBJECTIVES 1. To establish the efficacy of central venous catheter placement using both techniques in critically ill paediatric patients. 2. To determine the safety of central venous catheter placement using both techniques in critically ill paediatric patients. 3. To compare whether there are differences in the efficacy and safety of central venous catheter placement using ultrasound-guided techniques versus anatomical landmark techniques in critically ill paediatric patients. |
| Ethics approval(s) |
Approved 20/06/2019, Comite Local De Investigacion 1002 (COMBIOETICA 11 CEI 0062017103) (Paseo de los Insurgentes S/N, Los Paraísos, León, Guanajuato, 37328, Mexico; +1 52 477 7174800; investigaumae48@gmail.com), ref: R-2019-1002-028 |
| Health condition(s) or problem(s) studied | Central venous catheter placement in critically ill paediatric patients: ultrasound-guided versus anatomical landmark technique guided internal jugular vein catheterisation. |
| Intervention | 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. Interventions: Ultrasound-guided central venous catheter (CVC) placement (TGUS): real-time puncture using a linear transducer (Philips 7500), Seldinger technique, sterile catheter and gel; 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 of a single intervention per patient, performed under sedation/analgesia by standardised paediatric intensivists; 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 complication; 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 01/09/2020 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 1 Month |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 98 |
| Total final enrolment | 73 |
| Key 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) |
| Key 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 × 10⁹/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 |
| Date of first enrolment | 12/09/2019 |
| Date of final enrolment | 05/08/2020 |
Locations
Countries of recruitment
- Mexico
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 19/05/2026 | No | No | ||
| Other files | Child assent form | 11/06/2026 | No | No | |
| Participant information sheet | 11/06/2026 | No | Yes | ||
| Protocol file | 11/06/2026 | No | No | ||
| Statistical Analysis Plan | within the protocol | 11/06/2026 | No | No |
Additional files
- 49556_Abstract.pdf
- Abstract results
- 49556 Study_Protocol_SPIRIT_CVC_Ultrasound_vs_Landmark.pdf
- Protocol file
- 49556 Study_Protocol_SPIRIT_CVC_Ultrasound_vs_Landmark.pdf
- within the protocol
- 49556Child_Assent_Form.pdf
- Child assent form
- 49556 Participant_Information_and_Informed_Consent.pdf
- Participant information sheet
Editorial Notes
11/06/2026: Trial's existence confirmed by Instituto Mexicano del Suguro Social.
