The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to obtain bone marrow biopsy specimens in children. The hypothesis is that use of the powered device will improve the quantity and quality of bone marrow biopsy specimens when compared to the manual device.
The purpose of this randomized, prospective trial is to compare use of the standard manual bone marrow aspiration and biopsy device to use of the powered bone marrow aspiration and biopsy device (OnControl) to obtain bone marrow biopsy specimens in pediatric patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
44
Use of the manual bone marrow aspiration and biopsy device to collect bone marrow aspiration and bone marrow biopsy specimens.
Use of the powered bone marrow aspiration and biopsy device to collect bone marrow aspiration specimens and bone marrow biopsy specimens.
Christus Santa Rosa Children's Hospital
San Antonio, Texas, United States
Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device
Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation.
Time frame: within 24 hours of bone marrow sampling procedure
Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device
bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length.
Time frame: within 24 hours of the bone marrow sampling procedure
Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device
bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width.
Time frame: within 24 hours of the bone marrow sampling procedure
Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device
bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume
Time frame: within 24 hours of the bone marrow sampling procedure
Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device
number of needle passes required to capture one bone marrow biopsy specimen using the manual device and the powered device
Time frame: at time of the bone marrow sampling procedure
Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device
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measurement of the amount of time required to acquire a bone marrow aspiration specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the aspiration specimen has been collected.
Time frame: at time of the bone marrow sampling procedure
Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device
Within 4 hours of the bone marrow sampling procedure, the patient will report their level of pain post-procedure using the Wong-Baker FACES pain rating scale. The scale measures pain from 0-10, where higher numbers represent worse pain.
Time frame: within 4 hours of the bone marrow sampling procedure
Operator Satisfaction With Manual Device and Powered Device
Device operators will report their level of satisfaction with use of the manual device and the powered device to perform the bone marrow sampling procedure. Level of satisfaction is reported using a 0 to 10 scale, where higher numbers represent a higher level of satisfaction.
Time frame: Within 24 hours of the bone marrow sampling procedure
Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device
measurement of the amount of time required to acquire one bone marrow biopsy specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the biopsy specimen has been collected.
Time frame: at time of the bone marrow sampling procedure