Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot study to evaluate a restraint device for lumbar punctures. Designed to help improve the restraint techniques for lumbar puncture, the restraint device will be compared to the current standard of manual physical restraint in neonatal and pediatric patients (age 1 day to 90 days of life). The investigators will study 30 subjects, with 20 randomized for the experimental device and 10 randomized for the "control" group, which is current standard of care. The investigators' primary outcomes will include time of procedure, red blood cells in the cerebrospinal fluid as well as physician satisfaction. Subjects will be eligible if they are 1-90 days of life, and their treating physician believes lumbar puncture is indicated. There is no follow-up once the lumbar puncture has been completed and the data has been obtained.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positioning Device | Experimental | use of positioning device |
|
| Control | Active Comparator | institutional standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediatric Restraint for Lumbar Puncture | Device | Restraint for children 1-90 days of age that allows physician to position pt for optimal lumbar puncture procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of the lumbar puncture restraint board | one time use |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of the restraint board on the quality of the procedure (time of procedure, quality of specimen obtained, physician impression) | One time use |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Boettner, RN, BSN | Contact | 402 559-6256 | aboettner@unmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Edward Truemper, MD | UNMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital & Medical Center | Recruiting | Omaha | Nebraska | 68114 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 16, 2022 | |
| Reset | Jan 3, 2023 | |
| Release | Dec 5, 2023 | |
| Reset | Dec 26, 2023 | |
| Release | Dec 27, 2023 | |
| Reset | Jun 6, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 16, 2022 | Jan 3, 2023 | |||
| Dec 5, 2023 |
| ID | Term |
|---|---|
| D013129 | Spinal Puncture |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lumbar Puncture Device | Device | Lumbar Puncture positioner |
|
|
| Standard of Care | Other | Lumbar Puncture positioner |
|
| Dec 26, 2023 |
| Dec 27, 2023 | Jun 6, 2024 |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |