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Completed

NCT Number: NCT03477552

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

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.

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Key information

Conditions

Sickle Cell Crisis Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Vaso-Occlusive Crises

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP - Hopital Europeen Georges-Pompidou Paris, France, Paris, Île-de-France Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accuvein V400 device

Device

Sickle cell patients who need a new vein puncture in order to infuse them will benefit of AccuveinV400 device to illuminate their venous network

Routine procedure

Other

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

Primary outcomes

  1. Number of venipunctures

    Time frame: Time of the infusion procedure

    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 outcomes

  1. Time of the procedure

    Time frame: Time of the infusion procedure

    Time from the tourniquet inflation to the insertion of the catheter with a retrograde blood sample was recorded with a chronometer

  2. Procedure failure

    Time frame: Time of the infusion procedure

    Percentage of the procedure failure

  3. The need of a central venous catheter

    Time frame: Time of the infusion procedure

    Percentage of use of a central venous catheter due to failure of peripheral perfusion.

  4. Patient bone pain before and after the procedure

    Time frame: Before and within 1 hour after a successful peripheral IV placement

    Patient bone pain will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain) before and after the infusion procedure

  5. Anxiety before and after the procedure

    Time frame: Just before and within 1 hour after a successful peripheral IV placement

    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

  6. Patient satisfaction (pain)

    Time frame: Within 1 hour after a successful peripheral IV placement

    Patient pain related to the procedure will be evaluated by Visual Analogue Scale (between 0=no pain to10=intolerable pain)

  7. Patient satisfaction (procedure)

    Time frame: Within 1 hour after a successful peripheral IV placement

    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

  8. Nurse satisfaction (procedure)

    Time frame: Within 1 hour after a successful peripheral IV placement

    Nurse global satisfaction of the procedure will be evaluated by Likert scale (between 1=not at all anxiety to 5=extremely anxious)

  9. Nurse satisfaction (quality of placement)

    Time frame: Within 1 hour after a successful peripheral IV 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)

  10. Qualitative interview of the Accuvein use

    Time frame: An average of one week after the procedure

    Verbatim of a semi-structured interview by a psychologist of 10 to 15 patients (and their nurse) often hospitalized, in the Accuvein Arm

  11. Side effects of the procedure

    Time frame: Time of the infusion procedure

    Complication rate of the peripheral venous catheter procedure (hematoma, bleeding, malaise).

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Efficacy of AccuVein V400 to Facilitate Peripheral Intravenous Placement in Sickle Cell Disease Adults With Vaso-occlusive Crisis : a Randomized Clinical Trial

Acronym: PERFID

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 26, 2018
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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