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Procedure

Flush Group 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of unreadable biopsy slides

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

TriHealth Inc.Lead Sponsor

97 Previous Clinical Trials

53,468 Total Patients Enrolled

Austin Pittman, BSN, RNPrincipal InvestigatorTriHealth Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How large is the participant pool for this clinical trial in its entirety?

"Affirmative. Records from clinicaltrials.gov highlight the ongoing patient recruitment for this medical trial, initially shared on December 1st, 2023 and last revised on April 15th, 2024. The aim is to enroll a total of 120 participants at one designated site."

Answered by AI

Is the enrollment for this study currently available to prospective participants?

"Indeed, the details on clinicaltrials.gov suggest that this investigation is currently in need of participants. Its initial posting date was December 1st, 2023, with the most recent modification made on April 15th, 2024. The study aims to enroll a total of 120 patients from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cold Saline Irrigation Before Endobronchial Biopsy

2023. "Cold Saline Irrigation Before Endobronchial Biopsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06373224.

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