Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients

NCT ID: NCT01643291

Last Updated: 2015-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-05-31

Brief Summary

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Hematology-oncology patients may require frequent lumbar puncture for diagnosis, assessment and therapy. When LP is difficult, the patient may endure multiple attempts, prolonged anesthesia time, and with failure of LP may require fluoroscopy-guidance with associated radiation exposure. This investigation will evaluate lumbar punctures performed in the intraoperative setting by oncologists with ultrasound guidance performed by the anesthesiologist in the leukemic pediatric population. The investigators hypothesis is that anesthesiologist guided ultrasound assistance will decrease intraoperative time, number of attempts and need to have the procedure done with fluoroscopy minimizing radiation exposure.

Detailed Description

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Conditions

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Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound

Group Type EXPERIMENTAL

Ultrasound

Intervention Type PROCEDURE

Ultrasound guidance for difficult lumbar punctures in the leukemic pediatric population.

Interventions

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Ultrasound

Ultrasound guidance for difficult lumbar punctures in the leukemic pediatric population.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing LP as per Heme-Onc clinic who have been deemed to be difficult LP placements.

Exclusion Criteria

* Patients having concomitant procedures (bone marrow bx, etc.)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tarun Bhalla, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Ferre RM, Sweeney TW, Strout TD. Ultrasound identification of landmarks preceding lumbar puncture: a pilot study. Emerg Med J. 2009 Apr;26(4):276-7. doi: 10.1136/emj.2007.057455.

Reference Type BACKGROUND
PMID: 19307389 (View on PubMed)

Abo A, Chen L, Johnston P, Santucci K. Positioning for lumbar puncture in children evaluated by bedside ultrasound. Pediatrics. 2010 May;125(5):e1149-53. doi: 10.1542/peds.2009-0646. Epub 2010 Apr 19.

Reference Type BACKGROUND
PMID: 20403933 (View on PubMed)

Ayalin T, Lam SH. Ultrasound-assisted lumbar puncture in infants. Acad Emerg Med. 2011 Apr;18(4):e36. doi: 10.1111/j.1553-2712.2011.01044.x. No abstract available.

Reference Type BACKGROUND
PMID: 21496132 (View on PubMed)

Other Identifiers

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IRB12-00335

Identifier Type: -

Identifier Source: org_study_id

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