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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Anesthesia
• Intervention / Treatment: Device: Spinal needle

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria
    • Medizinische Universitat Wien
• Finland
  • Seinäjoki, Finland, 60220
    • Sejnjoen Central Hospital
• Germany
  • Berlin, Germany, 12203
    • Charite Campus Benjamin Franklin
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig
• Spain
  • Madrid, Spain, 28223
    • Hospital Universitario Quirónsalud Madrid
• Switzerland
  • Zürich, Switzerland, 8008
    • Schulthess Klinik, Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Any participants who require a spinal needle device as part of their routine medical care.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; Participants who require a BD Spinal needle	Device: Spinal needle; Insertion of a spinal needle to perform the neuraxial procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).	Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure.	From insertion up to 7 days post procedure
Primary Performance: Incidence of Successful Needle Placement	Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub.	During the insertion procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.	Incidence of device/procedure-related adverse events including the incidence of any spinal/epidural hematoma.	From insertion up to 7 days post procedure
Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).	Incidence of any device or procedure-related adverse events, including the incidence of any nerve damage (pain or weakness lower extremities).	From insertion up to 7 days post procedure
Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)	Incidence of device/procedure-related adverse events including the incidence of any infection (meningitis, spinal abscess)	From insertion up to 7 days post procedure
Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site.	Incidence of device/procedure-related adverse events including the incidence of any pain, skin redness, irritation at or near the skin puncture site.	From insertion up to 7 days post procedure
Secondary Safety: Incidence of Any Needle or Procedure-related Backache.	Incidence of device/procedure-related adverse events including the incidence of backache.	From insertion up to 7 days post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	After spinal needle placement
Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey.	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.	After spinal needle placement
Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey.	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.	After spinal needle placement

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Collaborators: Cromsource
• Investigators: Study Director: Klaus Hoerauf, MD, Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): July 22, 2022

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MDS-20EPSPEU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No