Trial · NCT05214560
Prospective Clinical Evaluation of BD Spinal Needles
NCT05214560, Completed, Becton, Dickinson and Company; results first posted 2024-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prospective Clinical Evaluation of BD Spinal Needles. Trials, record NCT05214560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05214560
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prospective Clinical Evaluation of BD Spinal Needles
- NCT number
- NCT05214560
- Status
- Completed
- Enrollment
- 160 participants, actual
- Lead sponsor
- Becton, Dickinson and Company
- Conditions
- Analgesia, Anesthesia
- Interventions
- Spinal needle
- First posted
- 2022-01-28
- Last updated
- 2024-08-19
- Results first posted
- 2024-08-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Safety: Incidence of Post-dural Puncture Headache (PDPH). | From insertion up to 7 days post procedure | Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure. |
| Primary | Primary Performance: Incidence of Successful Needle Placement | During the insertion procedure | Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub. |
| Secondary | Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma. | From insertion up to 7 days post procedure | Incidence of device/procedure-related adverse events including the incidence of any spinal/epidural hematoma. |
| Secondary | Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities). | 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). |
| Secondary | Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess) | From insertion up to 7 days post procedure | Incidence of device/procedure-related adverse events including the incidence of any infection (meningitis, spinal abscess) |
| Secondary | Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site. | 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. |
| Secondary | Secondary Safety: Incidence of Any Needle or Procedure-related Backache. | From insertion up to 7 days post procedure | Incidence of device/procedure-related adverse events including the incidence of backache. |
| Other | 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 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. |
| Other | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey. | 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. |
| Other | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey. | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Safety: Incidence of Post-dural Puncture Headache (PDPH). | From insertion up to 7 days post procedure | 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. | % of subjects with a PDPH | NUMBER |
| PRIMARY | Primary Performance: Incidence of Successful Needle Placement | During the insertion procedure | 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 | % of successful needle placement | NUMBER |
| SECONDARY | Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma. | From insertion up to 7 days post procedure | 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. | % of subject with a spinal hematoma | NUMBER |
| SECONDARY | Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities). | From insertion up to 7 days post procedure | 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. | % of subject with a nerve damage | NUMBER |
| SECONDARY | Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess) | From insertion up to 7 days post procedure | 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. | % of subject with an infection | NUMBER |
| SECONDARY | Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site. | From insertion up to 7 days post procedure | 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. | % subjects with pain/readness/irritation | NUMBER |
| SECONDARY | Secondary Safety: Incidence of Any Needle or Procedure-related Backache. | From insertion up to 7 days post procedure | 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. | % of subjects with backache | NUMBER |
| OTHER_PRE_SPECIFIED | 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 spinal needle placement | 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 this specific measure. 143 is the overall number of subjects analyzed because 1 physician did not complete the survey. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey. | After spinal needle placement | 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. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey. | After spinal needle placement | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Safety: Incidence of Post-dural Puncture Headache (PDPH). | All Participants | 2.8 | 95% Confidence Interval 0.8 to 7.1 | % of subjects with a PDPH | |
| Primary Performance: Incidence of Successful Needle Placement | All Participants | 98.6 | 95% Confidence Interval 95.1 to 99.8 | % of successful needle placement | |
| Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma. | All Participants | 0.0 | 95% Confidence Interval 0.0 to 2.5 | % of subject with a spinal hematoma | |
| Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities). | All Participants | 0.0 | 95% Confidence Interval 0.0 to 2.5 | % of subject with a nerve damage | |
| Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess) | All Participants | 0.0 | 95% Confidence Interval 0.0 to 2.5 | % of subject with an infection | |
| Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site. | All Participants | 1.4 | 95% Confidence Interval 0.2 to 4.9 | % subjects with pain/readness/irritation | |
| Secondary Safety: Incidence of Any Needle or Procedure-related Backache. | All Participants | 0.7 | 95% Confidence Interval 0.0 to 3.8 | % of subjects with backache | |
| 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. | All Participants | 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. | All Participants | 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. | All Participants | PIs were agree with stylet helped to determine the direction of spinal needle tip | 131 | Participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 160 | |
| Overall Study | Enrolled Set | All Participants | 160 | |
| Overall Study | Evaluable Set | All Participants | 144 | |
| Overall Study | Safety Set | All Participants | 142 | |
| Overall Study | COMPLETED | All Participants | 142 | |
| Overall Study | NOT COMPLETED | All Participants | 18 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Procedural failure | General disorders | All Participants | 1 | 144 | 1 |
| other | Rhinitis | Infections and infestations | All Participants | 1 | 144 | 1 |
| other | Injection site irritation | Injury, poisoning and procedural complications | All Participants | 1 | 144 | 1 |
| other | Post lumbar puncture syndrome | Injury, poisoning and procedural complications | All Participants | 4 | 144 | 4 |
| other | Puncture site pain | Injury, poisoning and procedural complications | All Participants | 1 | 144 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | All Participants | 3 | 144 | 3 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | All Participants | 1 | 144 | 1 |
| other | Headache | Nervous system disorders | All Participants | 3 | 144 | 3 |
| other | Paresthesia | Skin and subcutaneous tissue disorders | All Participants | 1 | 144 | 1 |
| other | Hypotension | Vascular disorders | All Participants | 5 | 144 | 5 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 0 | 144 |
| Total, other adverse events | All Participants | 17 | 144 |
| Total, serious adverse events | All Participants | 0 | 144 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05214560
GET https://conductscience.org/api/trials/v1/NCT05214560/registered