Cold Saline Irrigation Before Endobronchial Biopsy

Lung Diseases Clinical Trial

Official title:

Evaluating the Use of Preventive Cold Saline to Decrease Bleeding Associated With Endobronchial Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06373224
• Other study ID #: 23-037
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: February 2, 2025

Study information

• Verified date: April 2024
• Source: TriHealth Inc.
• Contact: Rachel Baker, PhD, RN
• Phone: 513-569-6191
• Email: Rachel_Baker2[@]trihealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2, 2025
• Est. primary completion date: December 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Other:
• Flush
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.

Locations

Country	Name	City	State
United States	Bethesda North Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of unreadable biopsy slides	Number of 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