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Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service (KatECHO)

Primary Purpose

Catheterization, Peripheral, Echography, Hospital Units

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ultrasound guidance and therapeutic communication
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Catheterization, Peripheral

Eligibility Criteria

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

Inclusion Criteria:

  • Hospitalized in the post-emergency unit
  • Requiring the placement of a venous catheter in the post-emergency unit
  • Affiliation to social security or benefiting from such a scheme
  • Informed and written consent signed

Exclusion Criteria:

  • Protected person (art. L1121-5 to L1121-8 of the CSP)
  • Patient included in another interventional study
  • Patient already included for a first catheter placement in the post-emergency unit.

Sites / Locations

  • CHU Grenoble AlpesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

echo guidance

conventional

Arm Description

insertion of a peripheral venous catheter with ultrasound guidance and therapeutic communication

insertion of a peripheral venous catheter conventionally

Outcomes

Primary Outcome Measures

successful placement of a venous catheter on the first attempt
percentage of successful placement of a venous catheter on the first attempt

Secondary Outcome Measures

patient experience
not validated Satisfaction questionnaire and pain scale. score between 0 and 30 corresponding to high satisfaction
number of attempts to insert a peripheral venous catheter
Average in each group of the number of attempts
number of calls for a second nurse in the service
Average in each group of the number of service's interveners for a catheter placement
number of calls to a nurse anesthetist
Average in each group of the number of external interveners
location of the final placement site
Proportion of patients in each group according to the location of the final placement site
the caliber of the catheter placed
Proportion of patients in each group according to the caliber of the catheter placed
infectious or thromboembolic events
total number of infectious or thromboembolic events at the implantation site during the patient's stay in the post-emergency unit
duration of catheter placement
Average duration, in minutes, of catheter placement in each group
functional life of the catheter
functional life of the catheter, by group.
Satisfaction of nursing staff
not validated Satisfaction questionnaire for nursing staff in the post-emergency unit . score between 0 and 55 corresponding to a high satisfaction

Full Information

First Posted
January 11, 2021
Last Updated
September 15, 2022
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT04856826
Brief Title
Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service
Acronym
KatECHO
Official Title
Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

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
Compare the number of attempts to place a peripheral venous catheter in the group of patients hospitalized in the post-emergency unit and benefiting from echo guidance and therapeutic communication, to the group of patients hospitalized on the post-emergency unit using traditional technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheterization, Peripheral, Echography, Hospital Units

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
echo guidance
Arm Type
Experimental
Arm Description
insertion of a peripheral venous catheter with ultrasound guidance and therapeutic communication
Arm Title
conventional
Arm Type
No Intervention
Arm Description
insertion of a peripheral venous catheter conventionally
Intervention Type
Device
Intervention Name(s)
ultrasound guidance and therapeutic communication
Intervention Description
insertion of a peripheral venous catheter with ultrasound guidance and therapeutic communication
Primary Outcome Measure Information:
Title
successful placement of a venous catheter on the first attempt
Description
percentage of successful placement of a venous catheter on the first attempt
Time Frame
within the hour after insertion of peripheral venous catheter
Secondary Outcome Measure Information:
Title
patient experience
Description
not validated Satisfaction questionnaire and pain scale. score between 0 and 30 corresponding to high satisfaction
Time Frame
within the hour after insertion of peripheral venous catheter
Title
number of attempts to insert a peripheral venous catheter
Description
Average in each group of the number of attempts
Time Frame
within the hour during insertion of peripheral venous catheter
Title
number of calls for a second nurse in the service
Description
Average in each group of the number of service's interveners for a catheter placement
Time Frame
within the hour during insertion of peripheral venous catheter
Title
number of calls to a nurse anesthetist
Description
Average in each group of the number of external interveners
Time Frame
within the hour during insertion of peripheral venous catheter
Title
location of the final placement site
Description
Proportion of patients in each group according to the location of the final placement site
Time Frame
within the hour during insertion of peripheral venous catheter
Title
the caliber of the catheter placed
Description
Proportion of patients in each group according to the caliber of the catheter placed
Time Frame
within the hour during insertion of peripheral venous catheter
Title
infectious or thromboembolic events
Description
total number of infectious or thromboembolic events at the implantation site during the patient's stay in the post-emergency unit
Time Frame
4 days
Title
duration of catheter placement
Description
Average duration, in minutes, of catheter placement in each group
Time Frame
within the hour during insertion of peripheral venous catheter
Title
functional life of the catheter
Description
functional life of the catheter, by group.
Time Frame
4 days
Title
Satisfaction of nursing staff
Description
not validated Satisfaction questionnaire for nursing staff in the post-emergency unit . score between 0 and 55 corresponding to a high satisfaction
Time Frame
at the end of study inclusion, at 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized in the post-emergency unit Requiring the placement of a venous catheter in the post-emergency unit Affiliation to social security or benefiting from such a scheme Informed and written consent signed Exclusion Criteria: Protected person (art. L1121-5 to L1121-8 of the CSP) Patient included in another interventional study Patient already included for a first catheter placement in the post-emergency unit.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Duhoo
Phone
+33476767094
Email
jduhoo@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Arnaud
Phone
+33476767838
Email
marnaud3@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perrine Dumanoir
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Grenoble Alpes
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Duhoo
Phone
0476767094
Email
jduhoo@chu-grenoble.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service

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