Cold Saline Irrigation for Lung Disease

Overseen By Rachel Baker, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TriHealth Inc.

Must not be taking: Anticoagulants

Disqualifiers: Under 18, Pregnant, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to reduce bleeding during lung biopsies. The researchers will test whether flushing the bronchial wall with cold saline (Cold Saline Irrigation) minimizes bleeding, potentially leading to clearer biopsy slides and faster diagnosis. Participants will either receive this cold saline treatment or follow standard care without it. This trial suits individuals undergoing an endobronchial ultrasound and biopsy at Bethesda North Hospital who do not have bleeding disorders and are not on blood thinners. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance diagnostic procedures.

Do I need to stop my current medications for the trial?

If you are taking anticoagulant medications, you must stop them for the procedure to participate in the trial.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you must stop taking anticoagulant medications (blood thinners) before the procedure.

What prior data suggests that cold saline irrigation is safe for reducing bleeding during lung biopsies?

Research has shown that using cold saline (a saltwater solution) is a safe method. It has been successfully applied in lung treatments, such as for pulmonary alveolar proteinosis. This process involves rinsing the lungs with cold saline to improve breathing.

Cold saline irrigation is usually well-tolerated and resembles a common lung procedure called bronchoalveolar lavage (BAL), which involves washing out the lungs with a fluid to examine lung issues and is considered safe.

Controlling bleeding is crucial when treating lung problems. Cold saline helps by tightening blood vessels, reducing bleeding, and making procedures like biopsies safer.

Overall, previous safe use in similar procedures supports the use of cold saline in lung treatments. It is designed to be gentle and helps clarify biopsy results by reducing bleeding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cold saline irrigation for lung disease because it introduces a novel technique for preparing the biopsy site. Unlike standard care, which involves no irrigation before a biopsy, this method uses cold saline to potentially reduce inflammation and improve biopsy accuracy. By directly applying cold saline to the bronchial wall, the technique might enhance the visibility and accessibility of the area to be biopsied, potentially leading to more accurate diagnoses. This innovative approach could offer a new way to optimize lung disease diagnostics, which excites researchers about its potential impact.

What evidence suggests that cold saline irrigation is effective for reducing bleeding during lung biopsies?

This trial will compare cold saline irrigation with standard care during lung biopsies. Research has shown that cold saline (saltwater) can help control bleeding during lung procedures. Specifically, studies have found that iced saline effectively manages bleeding in the airways by narrowing blood vessels, which reduces bleeding. This method resembles how cold saline has been used to aid lung function in other conditions. Overall, early evidence suggests that cold saline irrigation could make lung biopsies faster and safer by reducing blood contamination. ^{1 2 3 4 6}

Who Is on the Research Team?

Austin Pittman, BSN, RN

Principal Investigator

TriHealth Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

I am unable to give consent for research participation.

I am under 18 years old.

Had a biopsy taken immediately prior to the endobronchial ultrasound

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo endobronchial ultrasound and biopsy with or without cold saline irrigation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the biopsy procedure

up to 12 hours

What Are the Treatments Tested in This Trial?

Interventions

• Cold Saline Irrigation

Trial Overview 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.

How Is the Trial Designed?

Group I: Flush Group Experimental Treatment 1 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 Group Active Control 1 Intervention

No irrigation before the biopsy

Who Is Running the Clinical Trial?

TriHealth Inc.

Lead Sponsor

Trials

103

Recruited

54,100+

Published Research Related to This Trial

In a study involving 23 patients with chronic rhinosinusitis and 9 healthy subjects, both heated and room-temperature saline nasal irrigation significantly improved mucociliary clearance, as measured by saccharin transit time.

There was no significant difference in the effectiveness of heated saline compared to room-temperature saline, indicating that warming the saline does not provide additional benefits for patients with chronic rhinosinusitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Heating up Saline for Nasal Irrigation Improve Mucociliary Function in Chronic Rhinosinusitis? Nimsakul, S., Ruxrungtham, S., Chusakul, S., et al.[2018]

In a study involving 403 children with mild and asymptomatic Omicron infections, physiological seawater nasal irrigation (PSNI) significantly reduced the duration of viral shedding compared to a control group, with a median duration of 2.40 days versus 3.09 days (P = 0.014).

The use of PSNI was particularly beneficial for unvaccinated children, suggesting it may be an effective supportive therapy for managing mild COVID-19 symptoms in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of physiological seawater nasal irrigation for the treatment of children with SARS-CoV-2 Omicron BA.2 variant infection: a randomized controlled trial. Lin, JL., Zhang, F., Li, YB., et al.[2023]

The lung lavage technique described is safe and effective for treating patients with pulmonary alveolar proteinosis, leading to significant improvements in symptoms and chest X-ray results within a day.

Using normal saline for lung lavage is as effective as solutions containing heparin and acetylcysteine, and incorporating chest percussion during the procedure enhances the effectiveness and efficiency of the lavage process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the treatment of pulmonary alveolar proteinosis. Kao, D., Wasserman, K., Costley, D., et al.[2015]

In a study involving 22 patients with chronic bronchitis or bronchiectasis, direct instillations of normal saline and N-acetylcysteine into the trachea did not significantly affect gas exchange, indicating the treatment is physiologically safe.

Despite the lack of change in gas exchange, pulmonary function tests showed significant overall improvement in lung function after the treatment, suggesting that tracheobronchial lavage can be an effective therapeutic approach for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of direct instillations of a therapeutic mixture into the tracheobronchial tree. Paez, PN., Mansangkay, M., Sproule, BJ.[2018]

In a study of 127 adults with chronic nasal and sinus symptoms, nasal irrigations using large volumes and low positive pressure significantly improved quality of life, as shown by lower SNOT-20 scores compared to saline sprays over an 8-week period.

At the 8-week mark, only 40% of patients using the irrigation method reported frequent symptoms, compared to 61% in the spray group, indicating that the irrigation method was more effective in reducing symptom frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. Pynnonen, MA., Mukerji, SS., Kim, HM., et al.[2015]

Nasal saline irrigation (SI) has been shown to reduce SARS-CoV-2 levels in the nasopharynx and speed up viral clearance, suggesting it could be an effective adjunctive treatment for COVID-19.

Patients using SI reported significant symptom relief and a lower risk of hospitalization, with no reported harm, making it a safe and inexpensive hygiene measure to complement other COVID-19 prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saline nasal irrigation and gargling in COVID-19: a multidisciplinary review of effects on viral load, mucosal dynamics, and patient outcomes. Huijghebaert, S., Parviz, S., Rabago, D., et al.[2023]

In a study involving 146 patients with ventricular tachycardia (VT) due to structural heart disease, the radiofrequency catheter ablation system with internal saline irrigation achieved an acute success rate of 75%, eliminating all mappable VTs in 106 patients.

The procedure had a moderate complication rate of 8%, with 41% of patients showing no inducible VT after the procedure, indicating that while effective, there is still a risk of sustained arrhythmias post-ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of ventricular tachycardia in patients with structural heart disease using cooled radiofrequency energy: results of a prospective multicenter study. Cooled RF Multi Center Investigators Group. Calkins, H., Epstein, A., Packer, D., et al.[2023]

Normal saline instillation (NSI) during endotracheal suction in pediatric patients was linked to a temporary decrease in blood oxygen saturation, indicating a potential risk during the procedure.

The current evidence on NSI's efficacy and safety is limited and of low quality, highlighting the need for more robust clinical trials to better understand its effects and improve clinical practices in pediatric intensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of normal saline instillation and paediatric endotracheal suction: An integrative review. Schults, J., Mitchell, ML., Cooke, M., et al.[2019]

A study found that 35.1% of homemade saline nasal irrigation solutions became contaminated with bacteria within a week, especially those made with boiled water and hypotonic solutions.

To prevent bacterial growth, it's recommended to refrigerate saline solutions, and if stored at room temperature, they should be isotonic or hypertonic and made from bottled or distilled water.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for decreasing contamination of homemade nasal saline irrigation solutions. Hardy, ET., Stringer, SP., O'Callaghan, R., et al.[2016]

In a study involving 60 patients over 17 days, a sodium chloride nasal gel at a concentration of 6.0mg/g was found to provide greater comfort and less stinging sensation compared to a 4.5mg/g concentration.

Both concentrations of the nasal gel did not show a significant difference in humidification effectiveness, indicating that while comfort levels varied, the ability to humidify the nasal passages remained consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Ringer's lactate gel formulation on nasal comfort and humidification. Neves, MCD., Romano, FR., Guerra Filho, S.[2022]

Saline nasal irrigation is an effective adjunctive therapy for managing symptoms of chronic rhinosinusitis, with consensus guidelines supporting its use for various upper respiratory conditions.

The procedure is considered safe, with no serious adverse events reported, and minor side effects can be minimized through proper technique and salinity adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saline nasal irrigation for upper respiratory conditions. Rabago, D., Zgierska, A.[2021]

Citations

1. withpower.com withpower.com/trial/phase-lung-diseases-11-2023-fbdc6

Cold Saline Irrigation for Lung Disease · Info for Participants For example, lung lavage with saline has been shown to clear chest symptoms and improve lung function in patients with pulmonary alveolar proteinosis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7578496/

Bronchoalveolar lavage as a diagnostic procedure Bronchoalveolar lavage (BAL) is a commonly used procedure in the evaluation of lung disease as it allows for sampling of the lower respiratory tract.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352464225000604

Management of severe acute pulmonary haemorrhage in ... The overall management strategy should address control of symptomatic bleeding, identification of the bleeding source, and treatment of the underlying cause.

4. researchgate.net researchgate.net/publication/270473430_Iced_Saline_Bronchoalveolar_Lavage_-A_Potential_Therapeutic_Option_For_Pulmonary_Hemorrhage_After_Percutaneous_Coronary_Intervention_PCI

Iced Saline Bronchoalveolar Lavage –A Potential ... 22 Conan and Hurwitz reported that cold saline was an effective measure in controlling bronchial bleeding. 23 Approximately 1 L of saline ...

5. jtd.amegroups.org jtd.amegroups.org/article/view/43483/html

Bronchoalveolar lavage as a diagnostic procedure: a review ... This review focuses on common cellular and molecular findings of BAL in a wide range of lung diseases. Since the performance of the first lung irrigation in ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK430762/

Bronchoalveolar Lavage - StatPearls - NCBI Bookshelf - NIH Bronchoalveolar lavage (BAL) is a diagnostic procedure used in pulmonary medicine to obtain a fluid sample from the lungs' bronchoalveolar spaces.