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Transillumination Device for Peripheral Intravenous Placement in Patients With Sickle Cell Disease (PERFID) (PERFID)

Primary Purpose

Sickle Cell Crisis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Accuvein V400 device
Routine procedure
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sickle Cell Crisis focused on measuring Sickle Cell Crisis, intravenous catheter, transillumination

Eligibility Criteria

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

Inclusion Criteria:

  • Sickle cell patients (all genotypes)
  • Patients hospitalized for uncomplicated vaso-occlusive crisis (CVO) in Internal/general Medicine department
  • Patients requiring the placement or replacement of a peripheral intra-venous catheter in the Department of Internal/general Medicine
  • Patients arrived in the internal/general medicine department of the hospital between 9h and 18h and except weekends
  • Signed informed consent.
  • Affiliated to the French health care insurance.

Exclusion Criteria:

  • Signs of shock
  • Acute chest Syndrome
  • Central venous catheter already present
  • Indication to have a central venous catheter from the ourset
  • Patient who has already participated to the PERFID study during the current hospitalization
  • Refusal of the patient's participation
  • Pregnant or lactating woman
  • Patient under guardianship or curatorship

Sites / Locations

  • AP-HP - Hopital Europeen Georges-Pompidou Paris, France
  • CHU H. Mondor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Accuvein V400 device

Routine procedure

Arm Description

In the Accuvein group, the nurse uses the Accuvein device to identify the veins before any puncture to infuse the patient and then proceeds as usual, under illumination of the device.

In the control group, the nurse proceeds as usual to infuse the patient (visual identification in the light of the chamber and palpation)

Outcomes

Primary Outcome Measures

Number of venipunctures
Number of venipunctures until the peripheral IV placement (with a retrograde blood sample) or before failure (discontinuation after at least 3 attempts by 2 nurses and a maximum of 9 attempts in total).

Secondary Outcome Measures

Time of the procedure
Time from the tourniquet inflation to the insertion of the catheter with a retrograde blood sample was recorded with a chronometer
Procedure failure
Percentage of the procedure failure
The need of a central venous catheter
Percentage of use of a central venous catheter due to failure of peripheral perfusion.
Patient bone pain before and after the procedure
Patient bone pain will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain) before and after the infusion procedure
Anxiety before and after the procedure
Patient and nurse anxiety will be evaluated by a visual 5 points-Likert scale (between 1=not at all anxiety to 5=extremely anxious) of anxiety before and after the procedure
Patient satisfaction (pain)
Patient pain related to the procedure will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain)
Patient satisfaction (procedure)
Patient satisfaction of the procedure will be evaluated by a visual 5-points Likert scale (between 1=not at all anxiety to 5=extremely anxious) of satisfaction of the procedure
Nurse satisfaction (procedure)
Nurse global satisfaction of the procedure will be evaluated by Likert scale (between 1=not at all anxiety to 5=extremely anxious)
Nurse satisfaction (quality of placement)
Nurse satisfaction of the quality of the peripheral intravenous placement will be evaluated by Likert scale (between 1=not at all anxiety to 5=extremely anxious)
Qualitative interview of the Accuvein use
Verbatim of a semi-structured interview by a psychologist of 10 to 15 patients (and their nurse) often hospitalized, in the Accuvein Arm
Side effects of the procedure
Complication rate of the peripheral venous catheter procedure (hematoma, bleeding, malaise).

Full Information

First Posted
February 7, 2018
Last Updated
January 12, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT03477552
Brief Title
Transillumination Device for Peripheral Intravenous Placement in Patients With Sickle Cell Disease (PERFID)
Acronym
PERFID
Official Title
Efficacy of AccuVein V400 to Facilitate Peripheral Intravenous Placement in Sickle Cell Disease Adults With Vaso-occlusive Crisis : a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary goal of this randomized, controlled, open-label study is to determine the efficacy of AccuveinV400 (a transillumination veins device) to facilitate peripheral intravenous (IVP) catheter placement during a vaso-oclusive crisis. The investigators hypothesized that the number of attempts to a successful placement of a peripheral IV, our primary outcome, would be shorter with the assistance of the Accuvein V400. It is also expected that AccuveinV400 will reduce the time of the procedure, the rate of failure, the technique-related pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Crisis
Keywords
Sickle Cell Crisis, intravenous catheter, transillumination

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adult sickle cell patients who need of a new peripheral intravenous catheter placement (for fluid or porphine therapy) will be randomized between two arms : usual technique or use of the AccuveinV400® device). The randomization list (ratio 1: 1) will be made by the statistician of the study using the SAS software and balanced by random blocks of small size (2, 4, 6) to make it unpredictable. The randomization will be stratified on the center and the number of hospitalizations in the previous year (>3, <3).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Accuvein V400 device
Arm Type
Experimental
Arm Description
In the Accuvein group, the nurse uses the Accuvein device to identify the veins before any puncture to infuse the patient and then proceeds as usual, under illumination of the device.
Arm Title
Routine procedure
Arm Type
Active Comparator
Arm Description
In the control group, the nurse proceeds as usual to infuse the patient (visual identification in the light of the chamber and palpation)
Intervention Type
Device
Intervention Name(s)
Accuvein V400 device
Intervention Description
Sickle cell patients who need a new vein puncture in order to infuse them will benefit of AccuveinV400 device to illuminate their venous network
Intervention Type
Other
Intervention Name(s)
Routine procedure
Intervention Description
In the control group, the nurse proceeds as usual to infuse the patient (visual identification in the light of the chamber and palpation)
Primary Outcome Measure Information:
Title
Number of venipunctures
Description
Number of venipunctures until the peripheral IV placement (with a retrograde blood sample) or before failure (discontinuation after at least 3 attempts by 2 nurses and a maximum of 9 attempts in total).
Time Frame
Time of the infusion procedure
Secondary Outcome Measure Information:
Title
Time of the procedure
Description
Time from the tourniquet inflation to the insertion of the catheter with a retrograde blood sample was recorded with a chronometer
Time Frame
Time of the infusion procedure
Title
Procedure failure
Description
Percentage of the procedure failure
Time Frame
Time of the infusion procedure
Title
The need of a central venous catheter
Description
Percentage of use of a central venous catheter due to failure of peripheral perfusion.
Time Frame
Time of the infusion procedure
Title
Patient bone pain before and after the procedure
Description
Patient bone pain will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain) before and after the infusion procedure
Time Frame
Before and within 1 hour after a successful peripheral IV placement
Title
Anxiety before and after the procedure
Description
Patient and nurse anxiety will be evaluated by a visual 5 points-Likert scale (between 1=not at all anxiety to 5=extremely anxious) of anxiety before and after the procedure
Time Frame
Just before and within 1 hour after a successful peripheral IV placement
Title
Patient satisfaction (pain)
Description
Patient pain related to the procedure will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain)
Time Frame
Within 1 hour after a successful peripheral IV placement
Title
Patient satisfaction (procedure)
Description
Patient satisfaction of the procedure will be evaluated by a visual 5-points Likert scale (between 1=not at all anxiety to 5=extremely anxious) of satisfaction of the procedure
Time Frame
Within 1 hour after a successful peripheral IV placement
Title
Nurse satisfaction (procedure)
Description
Nurse global satisfaction of the procedure will be evaluated by Likert scale (between 1=not at all anxiety to 5=extremely anxious)
Time Frame
Within 1 hour after a successful peripheral IV placement
Title
Nurse satisfaction (quality of placement)
Description
Nurse satisfaction of the quality of the peripheral intravenous placement will be evaluated by Likert scale (between 1=not at all anxiety to 5=extremely anxious)
Time Frame
Within 1 hour after a successful peripheral IV placement
Title
Qualitative interview of the Accuvein use
Description
Verbatim of a semi-structured interview by a psychologist of 10 to 15 patients (and their nurse) often hospitalized, in the Accuvein Arm
Time Frame
An average of one week after the procedure
Title
Side effects of the procedure
Description
Complication rate of the peripheral venous catheter procedure (hematoma, bleeding, malaise).
Time Frame
Time of the infusion procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sickle cell patients (all genotypes) Patients hospitalized for uncomplicated vaso-occlusive crisis (CVO) in Internal/general Medicine department Patients requiring the placement or replacement of a peripheral intra-venous catheter in the Department of Internal/general Medicine Patients arrived in the internal/general medicine department of the hospital between 9h and 18h and except weekends Signed informed consent. Affiliated to the French health care insurance. Exclusion Criteria: Signs of shock Acute chest Syndrome Central venous catheter already present Indication to have a central venous catheter from the ourset Patient who has already participated to the PERFID study during the current hospitalization Refusal of the patient's participation Pregnant or lactating woman Patient under guardianship or curatorship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Benoit Arlet, MD,PhD
Organizational Affiliation
Medicine interne department, Europeen Georges Pompidou Hopital, Paris, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Fischer
Organizational Affiliation
Medicine interne department, Europeen Georges Pompidou Hospital, Paris, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François Lionnet, MD
Organizational Affiliation
Medicine interne department, Tenon Hospital, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HP - Hopital Europeen Georges-Pompidou Paris, France
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75908
Country
France
Facility Name
CHU H. Mondor
City
Créteil
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transillumination Device for Peripheral Intravenous Placement in Patients With Sickle Cell Disease (PERFID)

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