The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

NCT00980070 | Unknown Phase 1

• 1 other identifier: 329-09-FB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Indication for Lumbar Puncture

Keywords

lumbar puncture positioning device

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of the lumbar puncture restraint board

  one time use

Secondary Outcomes (1)

• 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

Study Arms (2)

Positioning Device

EXPERIMENTAL

use of positioning device

Device: Pediatric Restraint for Lumbar Puncture; Device: Lumbar Puncture Device

Control

ACTIVE COMPARATOR

institutional standard of care

Other: Standard of Care

Interventions

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.

Positioning Device

Lumbar Puncture Device DEVICE

Lumbar Puncture positioner

Also known as: Lumbar Puncture positioner

Positioning Device

Standard of Care OTHER

Lumbar Puncture positioner

Control

Eligibility Criteria

• Age: 1 Day - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 1 to 90 days of life
• Indication for lumbar puncture procedure as determined by the treating physician
• Informed Consent from the subject's legal guardian indicating their acceptance of a lumbar puncture for the work-up of sepsis
• Informed consent to enrolled in said protocol

You may not qualify if:

• No indication for lumbar puncture procedure as determined by treating physician

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Childrens Hospital & Medical Center

Omaha, Nebraska, 68114, United States

RECRUITING

MeSH Terms

Interventions

Spinal Puncture; Standard of Care

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Edward Truemper, MD

  UNMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Boettner, RN, BSN

CONTACT

402 559-6256; aboettner@unmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: coordinator

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

US (1)