← Back to Search

Procedure

Cold Saline Irrigation for Lung Disease

N/A

Recruiting

Led By Austin Pittman, BSN, RN

Research Sponsored by TriHealth Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing an endobronchial ultrasound and biopsy at Bethesda North Hospital

Be older than 18 years old

Must not have

Unable to consent to involvement in the research study

Has a bleeding disorder/diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment until discharge from biopsy appointment, up to 12 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to reduce bleeding during lung biopsies by irrigating the biopsy site with cold saline before the procedure. This may help prevent blood contamination on the pathology slides, leading to quicker and more

Who is the study for?

This trial is for patients with lung disease who are undergoing an endobronchial ultrasound and biopsy. The study aims to include those who could benefit from a potential reduction in bleeding during the procedure.

What is being tested?

The trial is testing whether irrigating the bronchial wall with cold saline before taking a biopsy can reduce bleeding, thus preventing blood contamination on pathology slides and potentially shortening anesthesia time.

What are the potential side effects?

Potential side effects may include discomfort due to the cold temperature of the saline, temporary coughing from irritation caused by irrigation, or rare instances of bronchospasm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a lung biopsy using an ultrasound at Bethesda North Hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to give consent for research participation.

Select...

I have a bleeding disorder.

Select...

I am under 18 years old.

Select...

I do not speak English.

Select...

I am currently on blood thinners and cannot stop them for a procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment until discharge from biopsy appointment, up to 12 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment until discharge from biopsy appointment, up to 12 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until discharge from biopsy appointment, up to 12 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of unreadable biopsy slides

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Flush GroupExperimental Treatment1 Intervention

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.

Group II: Standard Care GroupActive Control1 Intervention

No irrigation before the biopsy

0 / 6Eligibility criteria met