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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flush Group | Experimental | 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. |
|
| Standard Care Group | No Intervention | No irrigation before the biopsy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flush | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Unreadable Biopsy Slides | cumulative number of unreadable slides across all biopsy slides noted by the pathologist to be unreadable due to blood on slide | from enrollment until discharge from biopsy appointment, up to 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Austin Pittman, BSN, RN | TriHealth Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bethesda North Hospital | Cincinnati | Ohio | 45242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Normal care with no cold saline flush |
| FG001 | Cold Saline Group | Cold saline flush before biopsy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Standard care without cold saline flush |
| BG001 | Cold Saline Group | Cold saline flush before biopsy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Unreadable Biopsy Slides | cumulative number of unreadable slides across all biopsy slides noted by the pathologist to be unreadable due to blood on slide | Posted | Number | number of unreadable slides | from enrollment until discharge from biopsy appointment, up to 12 hours | BiopsySlides | BiopsySlides |
|
|
from enrollment until discharge, up to 1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Standard care without cold saline flush | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nurse Researcher | TriHealth | 5135696191 | Rachel_Baker2@trihealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2023 | Feb 12, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | control group only | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
| BiopsySlides |
|
|
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Cold Saline Group | Cold saline flush before biopsy | 0 | 2 | 0 | 2 | 0 | 2 |
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