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

Primary Purpose

Critical Illness

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Internal jugular vein catheterization
Subclavian vein catheterization
Innominate vein catheterization
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Central venous access, Ultrasound-guided catheterization, Innominate vein, Brachiocephalic vein

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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 informed consent

Sites / Locations

  • Hospital Civil Fray Antonio AlcaldeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Internal jugular vein site

Subclavian vein site

Innominate vein site

Arm Description

Ultrasound-guided central venous catheterization at internal jugular vein site

Ultrasound-guided central venous catheterization at subclavian vein site

Ultrasound-guided central venous catheterization at innominate vein site

Outcomes

Primary Outcome Measures

Cannulation failure rate
Failure to cannulate selected vein after three attempts

Secondary Outcome Measures

Collapsibility associated with failure
Percentage of vein collapsibility independently associated with cannulation failure
Cannulation number of attempts
Number of attempts needed to attain cannulation
Procedure time
Time from skin puncture to guidewire confirmed into vessel (minutes)
Arterial puncture rate
Confirmed immediately after procedure with vascular ultrasound
Hematoma formation rate
Confirmed immediately after procedure with vascular ultrasound
Neumothorax rate
Confirmed immediately after procedure with lung ultrasound
Hemothorax rate
Confirmed immediately after procedure with lung ultrasound
Central line-associated blood infection rate
Confirmed with blood cultures

Full Information

First Posted
February 9, 2020
Last Updated
February 27, 2023
Sponsor
Hospital Civil de Guadalajara
Collaborators
Instituto Jalisciense de Cancerologia
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1. Study Identification

Unique Protocol Identification Number
NCT04265703
Brief Title
The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients
Acronym
INVADE
Official Title
Central Venous Access in Patients With Difficult Cannulation, A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil de Guadalajara
Collaborators
Instituto Jalisciense de Cancerologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Central venous access, Ultrasound-guided catheterization, Innominate vein, Brachiocephalic vein

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internal jugular vein site
Arm Type
Active Comparator
Arm Description
Ultrasound-guided central venous catheterization at internal jugular vein site
Arm Title
Subclavian vein site
Arm Type
Active Comparator
Arm Description
Ultrasound-guided central venous catheterization at subclavian vein site
Arm Title
Innominate vein site
Arm Type
Active Comparator
Arm Description
Ultrasound-guided central venous catheterization at innominate vein site
Intervention Type
Procedure
Intervention Name(s)
Internal jugular vein catheterization
Intervention Description
Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique.
Intervention Type
Procedure
Intervention Name(s)
Subclavian vein catheterization
Intervention Description
Catheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique.
Intervention Type
Procedure
Intervention Name(s)
Innominate vein catheterization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cannulation failure rate
Description
Failure to cannulate selected vein after three attempts
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Collapsibility associated with failure
Description
Percentage of vein collapsibility independently associated with cannulation failure
Time Frame
Baseline
Title
Cannulation number of attempts
Description
Number of attempts needed to attain cannulation
Time Frame
Baseline
Title
Procedure time
Description
Time from skin puncture to guidewire confirmed into vessel (minutes)
Time Frame
Baseline
Title
Arterial puncture rate
Description
Confirmed immediately after procedure with vascular ultrasound
Time Frame
Baseline
Title
Hematoma formation rate
Description
Confirmed immediately after procedure with vascular ultrasound
Time Frame
7 days
Title
Neumothorax rate
Description
Confirmed immediately after procedure with lung ultrasound
Time Frame
7 days
Title
Hemothorax rate
Description
Confirmed immediately after procedure with lung ultrasound
Time Frame
7 days
Title
Central line-associated blood infection rate
Description
Confirmed with blood cultures
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins 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 informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Ibarra-Estrada, MD
Phone
3317593502
Email
drmiguelibarra@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guadalupe Aguirre-Avalos, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Ibarra-Estrada, MD
Organizational Affiliation
Hospital Civil Fray Antonio Alcalde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Civil Fray Antonio Alcalde
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Ibarra-Estrada, MD
Phone
3317593502
Email
drmiguelibarra@hotmail.com
First Name & Middle Initial & Last Name & Degree
Guadalupe Aguirre-Avalos, MD
Email
guadalupe.aavalos@academicos.udg.mx
First Name & Middle Initial & Last Name & Degree
Quetzalcóatl Chávez-Peña, MD
First Name & Middle Initial & Last Name & Degree
Arnulfo López-Pulgarín, MD
First Name & Middle Initial & Last Name & Degree
Pável Aguilera-González, MD
First Name & Middle Initial & Last Name & Degree
Guadalupe Aguirre-Avalos, MD
First Name & Middle Initial & Last Name & Degree
Miguel Ibarra-Estrada, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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