Trial Outcomes & Findings for The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps (NCT NCT02133066)
NCT ID: NCT02133066
Last Updated: 2017-08-31
Results Overview
First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
128 participants
Primary outcome timeframe
30 minutes
Results posted on
2017-08-31
Participant Flow
Participant milestones
| Measure |
US-Assisted Site Marking for LP
Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap
|
Routine Lumbar Puncture
These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
64
|
|
Overall Study
COMPLETED
|
64
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps
Baseline characteristics by cohort
| Measure |
US-Assisted Site Marking for LP
n=64 Participants
Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap
|
Routine Lumbar Puncture
n=64 Participants
These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24 days
n=5 Participants
|
29 days
n=7 Participants
|
26 days
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
64 participants
n=7 Participants
|
128 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutesFirst attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group
Outcome measures
| Measure |
US-Assisted Site Marking for LP
n=64 Participants
Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap
|
Routine Lumbar Puncture
n=64 Participants
These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care
|
|---|---|---|
|
Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group
|
58 percent success
Interval 50.0 to 70.0
|
31 percent success
Interval 19.0 to 39.0
|
SECONDARY outcome
Timeframe: 30 minutesOverall success of lumbar punctures (within 3 attempts) in the non-ultrasound-assisted group compared to the ultrasound-assisted group
Outcome measures
| Measure |
US-Assisted Site Marking for LP
n=64 Participants
Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap
|
Routine Lumbar Puncture
n=64 Participants
These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care
|
|---|---|---|
|
Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group
|
75 percentage success
Interval 68.0 to 82.0
|
44 percentage success
Interval 38.0 to 52.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of the hospital stay, an expected average of 2 daysIf a lumbar puncture is not successful, this may lead to a longer hospitalization than necessary until a lumbar puncture can be completed (with interventional radiology or other resources). According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary hospitalization.
Outcome measures
| Measure |
US-Assisted Site Marking for LP
n=64 Participants
Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap
|
Routine Lumbar Puncture
n=64 Participants
These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care
|
|---|---|---|
|
Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients
|
46 hours
Interval 35.0 to 61.0
|
48.1 hours
Interval 37.0 to 62.0
|
SECONDARY outcome
Timeframe: Participants will be followed until discontinuation of antibiotics, an expected average of 2 daysIf a lumbar puncture is not successful, this may lead to unnecessary (prophylactic) antibiotic use until a lumbar puncture can be completed (with interventional radiology or other resources) to rule out meningitis. According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary antibiotics.
Outcome measures
| Measure |
US-Assisted Site Marking for LP
n=64 Participants
Mindray M7 Ultrasound marking
Bedside Ultrasound-Assisted Site Marking: Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
Mindray M7 Ultrasound: Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap
|
Routine Lumbar Puncture
n=64 Participants
These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician
Routine lumbar puncture: Lumbar puncture will be performed per routine standard of care
|
|---|---|---|
|
Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients
|
26.8 hours
Interval 19.0 to 30.0
|
25 hours
Interval 18.0 to 29.0
|
Adverse Events
US-Assisted Site Marking for LP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Lumbar Puncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place