ClinicalTrials.gg
RecruitingNCT04265703INVADEUpdated Mar 12, 2026

The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients

An interventional study of Internal jugular vein catheterization and Subclavian vein catheterization in Critical Illness, sponsored by Hospital Civil de Guadalajara. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Hospital Civil de Guadalajara · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
315
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Most recent guidelines suggest central venous access must be performed with real-time ultrasound guidance, and the most recommended site for cannulation is internal jugular vein (IJV); however, it is recognized that evidence for other sites is, at present, limited. Besides, guidelines does not account for patients with small vein cross-sectional area and/or respirophasic collapse, which can make the procedure more difficult or even impossible. The investigators aim to compare three different insertion sites for central venous access, with real-time ultrasound guidance

Read the detailed description

Ultrasound-guided cannulation of central veins is successful in >95% of the cases, according to the largest study so far. However, this and other studies with similar success rate, are performed in patients with general anesthesia and/or neuromuscular blockade, without spontaneous respiratory efforts. Critical care physicians and many other specialists frequently need to cannulate patients in special circumstances as hypovolemia, pain, anxiety, and respiratory efforts that promotes respirophasic variation in cross-sectional area, and even complete collapse of the vessel. These changes can increase the probability of posterior wall or arterial puncture, hematomas, pneumothorax, etc. Supraclavicular approach for cannulation of the subclavian vein is a method described since 1965, also giving direct access to the innominate vein, a larger vessel which is rarely collapsible regardless of volume status or respiratory efforts. Based on a previous pilot trial, in this multi-center, prospective, randomized, controlled trial, the investigators aim to compare the successfulness and safety of ultrasound-guided central venous cannulation at 3 different sites: internal jugular, subclavian, and innominate veins.

02

Conditions studied

  • Critical Illness

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Keywords

  • Central venous access
  • Ultrasound-guided catheterization
  • Innominate vein
  • Brachiocephalic vein
03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's planned enrollment of 315 is above the median of 90 across 926 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Hospital Civil de Guadalajara is the lead sponsor of 41 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins

Exclusion criteria

Exclusion Criteria:

  • Less than 18 years-old

    • Patients with previous failed attempts with non-ultrasound guided technique
    • Non-resolved pneumothorax/hemothorax at enrollment
    • Refusal to sign
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
315 participants (estimated)

Study arms

  • Active comparator
    Internal jugular vein site

    Ultrasound-guided central venous catheterization at internal jugular vein site

    Procedure: Internal jugular vein catheterization

  • Active comparator
    Subclavian vein site

    Ultrasound-guided central venous catheterization at subclavian vein site

    Procedure: Subclavian vein catheterization

  • Active comparator
    Innominate vein site

    Ultrasound-guided central venous catheterization at innominate vein site

    Procedure: Innominate vein catheterization

Interventions

  • ProcedureInternal jugular vein catheterization

    Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique.

  • ProcedureSubclavian vein catheterization

    Catheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique.

  • ProcedureInnominate vein catheterization

    Catheterization of innominate vein with supra-clavicular approach with real-time (in-plane) method, with neutral shoulder position and no shoulder retraction. Standard aseptic technique.

06

What researchers measure

Primary outcomes

  1. Cannulation failure rate

    Failure to cannulate selected vein at first attempt

    Time frame: Baseline

Secondary outcomes

  1. Central line-associated blood infection rate

    Confirmed with blood cultures

    Time frame: 28 days

  2. Collapsibility associated with failure

    Percentage of vein collapsibility independently associated with cannulation failure

    Time frame: Baseline

  3. Cannulation number of attempts

    Number of attempts needed to attain cannulation

    Time frame: Baseline

  4. Procedure time

    Time from skin puncture to guidewire confirmed into vessel (minutes)

    Time frame: Baseline

  5. Arterial puncture rate

    Confirmed immediately after procedure with vascular ultrasound

    Time frame: Baseline

  6. Hematoma formation rate

    Confirmed immediately after procedure with vascular ultrasound

    Time frame: 7 days

  7. Neumothorax rate

    Confirmed immediately after procedure with lung ultrasound

    Time frame: 7 days

  8. Hemothorax rate

    Confirmed immediately after procedure with lung ultrasound

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
  • Hospital Civil Fray Antonio Alcalde
    Guadalajara, 44280, Mexico
    Recruiting
    • Miguel Ibarra-Estrada, MD · Contactdrmiguelibarra@hotmail.com · 3317593502
    • Guadalupe Aguirre-Avalos, MD · Contactguadalupe.aavalos@academicos.udg.mx
    • Quetzalcóatl Chávez-Peña, MD · Sub investigator
    • Arnulfo López-Pulgarín, MD · Sub investigator
    • Pável Aguilera-González, MD · Sub investigator
    • Guadalupe Aguirre-Avalos, MD · Sub investigator
    • Miguel Ibarra-Estrada, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04265703
Lead sponsor
Hospital Civil de Guadalajara
Collaborators
Instituto Jalisciense de Cancerologia
Responsible party
Miguel Á Ibarra-Estrada (Principal Investigator, Hospital Civil de Guadalajara) — Principal investigator
First posted
Feb 11, 2020
Start date
Feb 27, 2024
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Mar 12, 2026

Study contacts

Miguel Ibarra-Estrada, MD
Contact
drmiguelibarra@hotmail.com
3317593502
Guadalupe Aguirre-Avalos, MD
Contact
Miguel Ibarra-Estrada, MD
principal investigator · Hospital Civil Fray Antonio Alcalde

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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