Lung Diseases
Conditions
Keywords
Biopsy
Brief summary
Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies.
Interventions
OTHERFlush
After identifying the lymph node or lesion to be biopsied on ultrasound, using the endobronchial ultrasound scope, two 60mL syringes of cold saline will be inserted, through the biopsy channel of the endobronchial ultrasound scope, directly onto the bronchial wall where the biopsies are to be performed. The saline will then be sucked out of the airway using the endobronchial ultrasound scope.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing an endobronchial ultrasound and biopsy at Bethesda North Hospital
Exclusion criteria
* Under 18 years old * Does not speak English * Unable to consent to involvement in the research study * Is pregnant * Has a bleeding disorder/diagnosis * Currently taking anticoagulant medications and not stopped for procedure * Documented low platelets (\<100,000) * Had a biopsy taken immediately prior to the endobronchial ultrasound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unreadable Biopsy Slides | from enrollment until discharge from biopsy appointment, up to 12 hours | cumulative number of unreadable slides across all biopsy slides noted by the pathologist to be unreadable due to blood on slide |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAustin Pittman, BSN, RN
TriHealth Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.5 years |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
None listed