Trial Outcomes & Findings for Prospective Clinical Evaluation of BD Spinal Needles (NCT NCT05214560)

NCT ID: NCT05214560

Last Updated: 2024-08-19

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

160 participants

Primary outcome timeframe

From insertion up to 7 days post procedure

Results posted on

2024-08-19

Participant Flow

The study was conducted at 6 sites in 5 European countries. The first participant was enrolled on February 14, 2022 and the last participant had the last study visit on July 22,2022.

The choice of the specific BD Spinal Needle type, size, and length required for an individual participant was left to the discretion of the clinician. In this post market study, 160 participants, who were to receive a neuraxial procedures with a BD Spinal Needle as per routine clinical practice, were observed through 7-days post procedure to assess for adverse events/complications.

Participant milestones

Participant milestones
Measure	All Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Overall Study STARTED	160
Overall Study Enrolled Set	160
Overall Study Evaluable Set	144
Overall Study Safety Set	142
Overall Study COMPLETED	142
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Overall Study Screening Failure	1
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2
Overall Study General anesthesia at the request of the surgeon	2
Overall Study Study physician not available for the anesthesia	3
Overall Study Anesthesia rejected by the patient on the day of surgery	1
Overall Study Device not listed in the study was used for the procedure	1
Overall Study Surgery not performed	3

Baseline Characteristics

Prospective Clinical Evaluation of BD Spinal Needles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=144 Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Age, Continuous	55.5 years STANDARD_DEVIATION 18.01 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	143 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Austria	5 participants n=5 Participants
Region of Enrollment Finland	35 participants n=5 Participants
Region of Enrollment Germany	73 participants n=5 Participants
Region of Enrollment Spain	31 participants n=5 Participants
Body Max Index	27.51 kg/m^2 STANDARD_DEVIATION 4.934 • n=5 Participants
Primary diagnosis for intervention Surgery of lower extremities	65 Participants n=5 Participants
Primary diagnosis for intervention Surgery of lower abdomen	16 Participants n=5 Participants
Primary diagnosis for intervention Surgery of perineum	2 Participants n=5 Participants
Primary diagnosis for intervention Surgery of hips and pelvis	9 Participants n=5 Participants
Primary diagnosis for intervention Obstetric	5 Participants n=5 Participants
Primary diagnosis for intervention Other	47 Participants n=5 Participants
Reason for neuraxial procedure Reason for neuraxial procedure:anesthesia	144 Participants n=5 Participants
Reason for neuraxial procedure Reason for neuraxial procedure:analgesia	0 Participants n=5 Participants
Reason for neuraxial procedure Reason for neuraxial procedure: other	0 Participants n=5 Participants
American Society of Anesthesiologists (ASA) physical status (PS) classification ASA PS Classification I	39 Participants n=5 Participants
American Society of Anesthesiologists (ASA) physical status (PS) classification ASA PS Classification II	82 Participants n=5 Participants
American Society of Anesthesiologists (ASA) physical status (PS) classification ASA PS Classification III	23 Participants n=5 Participants
Spinal needle placement details- Participant position during spinal needle procedure Lateral position	39 Participants n=5 Participants
Spinal needle placement details- Participant position during spinal needle procedure Sitting position	105 Participants n=5 Participants
Spinal needle placement details - Aseptic technique Aseptic technique = Chlorhexidine	26 Participants n=5 Participants
Spinal needle placement details - Aseptic technique Aseptic technique = Betadine	6 Participants n=5 Participants
Spinal needle placement details - Aseptic technique Aseptic technique = Other	112 Participants n=5 Participants
Spinal needle placement details - Local anesthesia Local anesthesia = Lidocaine 1%	105 Participants n=5 Participants
Spinal needle placement details - Local anesthesia Local anesthesia = Lidocaine 2%	5 Participants n=5 Participants
Spinal needle placement details - Local anesthesia Local anesthesia = Other	34 Participants n=5 Participants
Spinal needle placement details - Lumbar interspace L2-L3	12 Participants n=5 Participants
Spinal needle placement details - Lumbar interspace L3-L4	104 Participants n=5 Participants
Spinal needle placement details - Lumbar interspace L4-L5	27 Participants n=5 Participants
Spinal needle placement details - Lumbar interspace Other	1 Participants n=5 Participants
Spinal needle placement details - Number of Puncture attempts Number of Puncture attempts = 1	136 Participants n=5 Participants
Spinal needle placement details - Number of Puncture attempts Number of Puncture attempts = 2	3 Participants n=5 Participants
Spinal needle placement details - Number of Puncture attempts Number of Puncture attempts = 3	3 Participants n=5 Participants
Spinal needle placement details - Number of Puncture attempts Number of Puncture attempts = 4	2 Participants n=5 Participants
Spinal needle placement details - Number of Interspace levels attempts Number of Interspace levels attempts = 1	132 Participants n=5 Participants
Spinal needle placement details - Number of Interspace levels attempts Number of Interspace levels attempts = 2	10 Participants n=5 Participants
Spinal needle placement details - Number of Interspace levels attempts Number of Interspace levels attempts = 3	2 Participants n=5 Participants
Spinal needle placement details - Paresthesia verbalized by participant Paresthesia not verbalized by participant	138 Participants n=5 Participants
Spinal needle placement details - Paresthesia verbalized by participant Paresthesia verbalized by participant	6 Participants n=5 Participants
Spinal needle placement details - Spontaneous appearance of CSF emerging from the needle hub Spontaneous appearance of Cerebrospinal Fluid (CSF) emerging from the needle hub	142 Participants n=5 Participants
Spinal needle placement details - Spontaneous appearance of CSF emerging from the needle hub No Spontaneous appearance of Cerebrospinal Fluid (CSF) emerging from the needle hub	2 Participants n=5 Participants
Spinal needle placement details - BD Spinal needle type BD Spinal Quincke needle 22Gx90mm	5 Participants n=5 Participants
Spinal needle placement details - BD Spinal needle type BD Spinal Quincke needle 27Gx90mm	34 Participants n=5 Participants
Spinal needle placement details - BD Spinal needle type BD Spinal Whitacre needle 25Gx103mm plus BD Introducer 20Gx32mm	19 Participants n=5 Participants
Spinal needle placement details - BD Spinal needle type BD Spinal Whitacre needle 25Gx90mm plus BD Introducer 20Gx32mm	22 Participants n=5 Participants
Spinal needle placement details - BD Spinal needle type BD Spinal Whitacre needle 27Gx103mm plus BD Introducer 22Gx32mm	1 Participants n=5 Participants
Spinal needle placement details - BD Spinal needle type BD Spinal Whitacre needle 27Gx90mm plus BD Introducer 22Gx32mm	63 Participants n=5 Participants
Spinal needle placement details - BD Syringes BD Syringe size 5mL used	34 Participants n=5 Participants
Spinal needle placement details - BD Syringes BD Syringe size 10mL used	1 Participants n=5 Participants
Spinal needle placement details - BD Syringes No BD Syringe used	109 Participants n=5 Participants

PRIMARY outcome

Timeframe: From insertion up to 7 days post procedure

Population: Out of 144 participants who received a neuraxial procedure, a total of 142 participants received a successful placement of the study device and were included in the safety set, used for the primary safety calculation.

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

Outcome measures

Outcome measures
Measure	All Participants n=142 Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).	2.8 % of subjects with a PDPH Interval 0.8 to 7.1

PRIMARY outcome

Timeframe: During the insertion procedure

Population: 160 subjects signed informed consent. As 1 subject was screening failure, and for other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects: evaluable set, used for primary performance calculation.The study device could not be placed successfully in 1 subject due to pronounced left convex scoliosis and 1 subject with successful placement was not treated via the study device.142 subjects successfully received a placement of the study device

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

Outcome measures

Outcome measures
Measure	All Participants n=144 Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Primary Performance: Incidence of Successful Needle Placement	98.6 % of successful needle placement Interval 95.1 to 99.8

SECONDARY outcome

Timeframe: From insertion up to 7 days post procedure

Population: 160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for secondary safety calculation.

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

Outcome measures

Outcome measures
Measure	All Participants n=144 Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.	0.0 % of subject with a spinal hematoma Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	All Participants n=144 Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).	0.0 % of subject with a nerve damage Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: From insertion up to 7 days post procedure

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

Outcome measures

Outcome measures
Measure	All Participants n=144 Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)	0.0 % of subject with an infection Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=144 Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site.	1.4 % subjects with pain/readness/irritation Interval 0.2 to 4.9

SECONDARY outcome

Timeframe: From insertion up to 7 days post procedure

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

Outcome measures

Outcome measures
Measure	All Participants n=144 Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Secondary Safety: Incidence of Any Needle or Procedure-related Backache.	0.7 % of subjects with backache Interval 0.0 to 3.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=143 Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
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. BD Spinal Needle insertion was easy or very easy	135 Participants
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. BD Spinal Needle withdrawal after placement was easy or very easy	143 Participants
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. PIs were agree with "stylet helped to determine the direction of spinal needle tip"	131 Participants
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. PIs were agree or strongly agree with "stylet functioned properly during spinal needle placement".	143 Participants
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. Ease of BD Stylet removal from the spinal needle after placement was easy or very easy	142 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: After spinal needle placement

Population: Considering that the Spinal Introducer is an optional aid to perform the spinal procedure, 105 Introducers have been used by physicians to perform the study procedure, but only for 104 of 105 subjects for which the BD introducer has been used, the investigators completed the questionnaire and answered the respective question.

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.

Outcome measures

Outcome measures
Measure	All Participants n=104 Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey. Use of the BD Introducer was easy or very easy	104 Participants
Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey. PIs were agree with "introducer facilitated placement of spinal needle"	103 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: After spinal needle placement

Population: Considering that this study is an observational study in which the physicians performed the spinal procedure according to their clinical practice and hence, they could choose any ancillary devices to achieve the study procedure, 35 BD syringes have been used by physicians to perform the study procedure, and the investigators completed the questionnaire and answered the respective question.

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.

Outcome measures

Outcome measures
Measure	All Participants n=35 Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey. Reading BD Syringe graduations when preparing the dose for spinal injection was very easy	35 Participants
Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey. Securely connecting between the BD Syringe and the BD Spinal Needle hub was easy or very easy	32 Participants
Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey. Disconnecting the syringe from the spinal needle after injection was very easy	31 Participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=144 participants at risk Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.
General disorders Procedural failure	0.69% 1/144 • Number of events 1 • From the BD Spina needle insertion up to 7 days post procedure An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice. An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.
Infections and infestations Rhinitis	0.69% 1/144 • Number of events 1 • From the BD Spina needle insertion up to 7 days post procedure An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice. An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.
Injury, poisoning and procedural complications Injection site irritation	0.69% 1/144 • Number of events 1 • From the BD Spina needle insertion up to 7 days post procedure An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice. An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.
Injury, poisoning and procedural complications Post lumbar puncture syndrome	2.8% 4/144 • Number of events 4 • From the BD Spina needle insertion up to 7 days post procedure An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice. An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.
Injury, poisoning and procedural complications Puncture site pain	0.69% 1/144 • Number of events 1 • From the BD Spina needle insertion up to 7 days post procedure An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice. An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.
Musculoskeletal and connective tissue disorders Back pain	2.1% 3/144 • Number of events 3 • From the BD Spina needle insertion up to 7 days post procedure An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice. An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.
Musculoskeletal and connective tissue disorders Pain in extremity	0.69% 1/144 • Number of events 1 • From the BD Spina needle insertion up to 7 days post procedure An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice. An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.
Nervous system disorders Headache	2.1% 3/144 • Number of events 3 • From the BD Spina needle insertion up to 7 days post procedure An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice. An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.
Skin and subcutaneous tissue disorders Paresthesia	0.69% 1/144 • Number of events 1 • From the BD Spina needle insertion up to 7 days post procedure An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice. An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.
Vascular disorders Hypotension	3.5% 5/144 • Number of events 5 • From the BD Spina needle insertion up to 7 days post procedure An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice. An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.

Additional Information

Clinical Project Manager

Becton, Dickinson and Company

Phone: 00393452237718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI submits to Sponsor for review a draft 90 days prior to submission of thedraft for publication.Draft shall not divulge any confidential info.Sponsor hasthe right to:review and make comments on any proposed publication; withholdthe use of its name in connection with publication;make any results from thestudy known to its customers and governmental agencies prior topublication.The first publication of the study results shall be made inconjunction with the results from the other PIs.
Publication restrictions are in place

Restriction type: OTHER