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OpenTrials
Completed

NCT Number: NCT05214560

Prospective Clinical Evaluation of BD Spinal Needles

Post-market, observational study to assess the real-world safety and efficacy of BD Spinal Needles used in an on-market fashion.

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Key information

Conditions

Analgesia Agnosia Anesthesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Wien, Vienna, Austria

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About this study

Single-arm, post-market, observational, prospective study of participants who will receive neuraxial procedures with a BD Spinal Needle as part of their routine medical care.

Patients will be followed from BD Spinal needle insertion up to 7 days after the insertion according to the routine medical care and site policy.

Data collected will be gathered from the patient's medical charts.

Who can participate

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

Inclusion criteria

  • Any patient, regardless of age or gender, for which the investigator has decided that a neuraxial procedure must be performed utilizing BD Spinal Needles as part of their routine medical care
  • Expected to be available for observation through the study period (7-days post procedure)
  • Provision of signed and dated informed consent form (Note: Consent of guardian or parent may be required for patients under the age of 18 years; participant assent may be required as well.)

Exclusion criteria

  • Undergoing emergency surgery
  • Coagulopathy or bleeding disorder for which regional anesthesia poses an increased risk
  • History of neurological impairment or disease of the trunk or lower extremities.
  • Infection at or near the site of needle insertion
  • Previous spine surgery at the level involved in the study procedure

Treatment and study plan

Spinal needle

Device

Insertion of a spinal needle to perform the neuraxial procedure.

Primary outcomes

  1. Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).

    Time frame: From insertion up to 7 days post procedure

    Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure.

  2. Primary Performance: Incidence of Successful Needle Placement

    Time frame: During the insertion procedure

    Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub.

Secondary outcomes

  1. Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.

    Time frame: From insertion up to 7 days post procedure

    Incidence of device/procedure-related adverse events including the incidence of any spinal/epidural hematoma.

  2. Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).

    Time frame: From insertion up to 7 days post procedure

    Incidence of any device or procedure-related adverse events, including the incidence of any nerve damage (pain or weakness lower extremities).

  3. Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)

    Time frame: From insertion up to 7 days post procedure

    Incidence of device/procedure-related adverse events including the incidence of any infection (meningitis, spinal abscess)

  4. Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site.

    Time frame: From insertion up to 7 days post procedure

    Incidence of device/procedure-related adverse events including the incidence of any pain, skin redness, irritation at or near the skin puncture site.

  5. Secondary Safety: Incidence of Any Needle or Procedure-related Backache.

    Time frame: From insertion up to 7 days post procedure

    Incidence of device/procedure-related adverse events including the incidence of backache.

Other outcomes

  1. Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey.

    Time frame: After spinal needle placement

    After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure.

    The ease-of-use survey was conducted among physician investigator to obtain information on BD spinal needle and related stylet performance.

  2. Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey.

    Time frame: After spinal needle placement

    After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure.

    When the BD ancillary devices (e.g., spinal introducer) were used, the ease-of-use survey was conducted among physician investigator to obtain information on their performance.

  3. Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey.

    Time frame: After spinal needle placement

    After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure.

    When the BD ancillary devices (e.g., BD syringe) were used, the ease-of-use survey was conducted among physician investigator to obtain information on their performance.

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Collaborators

  • Cromsource

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Aug 19, 2024

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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