Anesthesia, Local, Infant Conditions
Conditions
Brief summary
Although the current standard for lumbar puncture and spinal anesthesia is the use of manual palpation of surface landmarks to identify the correct interspace, performance of the procedure at too high of a level may increase the incidence of adverse effects. The current study will evaluate the efficacy of ultrasound in identifying the correct intervertebral space for lumbar puncture thereby improving the safety of the procedure.
Interventions
DIAGNOSTIC_TESTUltrasound
Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
Inclusion criteria
* Patients less than 1 year of age scheduled for spinal anesthesia for elective lower abdominal, urologic, or lower extremity surgery at Nationwide Children's Hospital
Exclusion criteria
* Parents unwilling for their children to undergo spinal anesthesia for surgery. * Children with known spinal anomalies including sacral dimple. * Children with coagulation abnormalities or receiving anticoagulation which precludes the use of spinal anesthesia. * Children with superficial or deep infections over the spine which precludes the use of spinal anesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intended Interspace | Immediately prior to spinal anesthesia | The vertebral interspace that the anesthesia provider believes that they had marked & identified by manual palpation |
| Actual Interspace of Provider's Mark | Immediately prior to spinal anesthesia | The actual vertebral interspace that the anesthesia provider marked & identified, as verified by ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Conus Medullaris - Sitting | Immediately prior to spinal anesthesia | Assessing the level of the conus medullaris by ultrasound in the sitting position. |
| Time to Mark | Immediately prior to spinal anesthesia | The amount of time if took for the anesthesia provider to manually palpate and mark the desired interspace. |
| Time to Conduct Ultrasound | Immediately prior to spinal anesthesia | The amount of time it took for the investigator to identify the actual space that the provider marked using ultrasound. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Anesthesia Infants receiving spinal anesthesia for standard of care procedure
Ultrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Spinal Anesthesia | — |
|---|---|---|
| Age, Categorical <=18 years | 50 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Age, Continuous | 7 months | — |
| American Society of Anesthesiologists (ASA) status ASA I | 29 Participants | — |
| American Society of Anesthesiologists (ASA) status ASA II | 18 Participants | — |
| American Society of Anesthesiologists (ASA) status ASA III | 3 Participants | — |
| Height | 66.5 centimeters | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 50 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 50 Participants | — |
| Weight | 7.8 kilograms | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Actual Interspace of Provider's Mark
The actual vertebral interspace that the anesthesia provider marked & identified, as verified by ultrasound.
Time frame: Immediately prior to spinal anesthesia
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia | Actual Interspace of Provider's Mark | L2-3 | 5 Participants |
| Spinal Anesthesia | Actual Interspace of Provider's Mark | L4-5 | 21 Participants |
| Spinal Anesthesia | Actual Interspace of Provider's Mark | L3-4 | 24 Participants |
Primary
Intended Interspace
The vertebral interspace that the anesthesia provider believes that they had marked & identified by manual palpation
Time frame: Immediately prior to spinal anesthesia
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia | Intended Interspace | L4-5 | 25 Participants |
| Spinal Anesthesia | Intended Interspace | L2-3 | 1 Participants |
| Spinal Anesthesia | Intended Interspace | L3-4 | 24 Participants |
Secondary
Level of Conus Medullaris - Sitting
Assessing the level of the conus medullaris by ultrasound in the sitting position.
Time frame: Immediately prior to spinal anesthesia
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia | Level of Conus Medullaris - Sitting | T12-L1 | 9 Participants |
| Spinal Anesthesia | Level of Conus Medullaris - Sitting | L1-2 | 27 Participants |
| Spinal Anesthesia | Level of Conus Medullaris - Sitting | L2-3 | 9 Participants |
| Spinal Anesthesia | Level of Conus Medullaris - Sitting | L3-4 | 3 Participants |
| Spinal Anesthesia | Level of Conus Medullaris - Sitting | Unable to obtain | 2 Participants |
Secondary
Time to Conduct Ultrasound
The amount of time it took for the investigator to identify the actual space that the provider marked using ultrasound.
Time frame: Immediately prior to spinal anesthesia
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Spinal Anesthesia | Time to Conduct Ultrasound | 38.5 seconds |
Secondary
Time to Mark
The amount of time if took for the anesthesia provider to manually palpate and mark the desired interspace.
Time frame: Immediately prior to spinal anesthesia
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Spinal Anesthesia | Time to Mark | 25 seconds |