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

ConditionCritical Illness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHospital Civil de Guadalajara

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Less than 18 years-old

Patients with previous failed attempts with non-ultrasound guided technique

Non-resolved pneumothorax/hemothorax at enrollment

Refusal to sign informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Internal jugular vein catheterization

    Procedure/Surgery

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

  • Subclavian vein catheterization

    Procedure/Surgery

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

  • Innominate vein catheterization

    Procedure/Surgery

    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.

Treatment groups

315 Participants
are divided into 3 treatment groups
Group A: Internal jugular vein siteActive comparator 1 intervention
Group B: Subclavian vein siteActive comparator 1 intervention
Group C: Innominate vein siteActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Civil de Guadalajara

Lead sponsor

Instituto Jalisciense de Cancerologia

Collaborator

Source ClinicalTrials.gov
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