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

120 Participants Needed

Trial Summary

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 data supports the idea that Cold Saline Irrigation for Lung Disease is an effective treatment?

The available research shows that saline irrigation, similar to Cold Saline Irrigation, is beneficial for improving symptoms in conditions like chronic rhinosinusitis and pulmonary alveolar proteinosis. For example, lung lavage with saline has been shown to clear chest symptoms and improve lung function in patients with pulmonary alveolar proteinosis. Additionally, nasal saline irrigation helps improve mucociliary function, which is important for clearing mucus from the airways. These findings suggest that Cold Saline Irrigation could be effective for lung disease by helping clear mucus and improve lung function. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Cold Saline Irrigation for lung disease?

Research on lung lavage (washing out the lungs) with normal saline shows it can effectively clear the lungs and improve symptoms in patients with pulmonary alveolar proteinosis, a lung condition. This suggests that similar treatments like Cold Saline Irrigation might also help improve lung function in other lung diseases. ^{1 2 3 4 5}

What safety data exists for Cold Saline Irrigation for lung disease?

The provided research does not directly address Cold Saline Irrigation for lung disease. However, it includes studies on saline nasal irrigation, which is generally considered safe with no serious adverse events reported. Minor adverse effects can be managed with technique adjustments. The research on saline irrigation in other contexts, such as nasal and endotracheal applications, suggests that saline irrigation is safe, but specific safety data for Cold Saline Irrigation in lung disease is not available in the provided studies. ^{2 3 6 7 8}

Is cold saline irrigation safe for humans?

Saline nasal irrigation, which involves using saline (saltwater) to rinse the nasal passages, is generally safe with no serious adverse events reported. Minor side effects can be avoided by adjusting the technique and salinity. ^{2 3 6 7 8}

Is Cold Saline Irrigation a promising treatment for lung disease?

Cold Saline Irrigation could be promising because saline irrigation in general has been shown to help with respiratory conditions by improving symptoms and reducing viral loads. It is safe, easy to use, and can provide relief for patients with respiratory issues. ^{2 3 9 10 11}

How is Cold Saline Irrigation different from other treatments for lung disease?

Cold Saline Irrigation is unique because it involves using cold saline (saltwater) to potentially improve lung function, which is different from the more common use of saline at room temperature or heated for nasal irrigation in respiratory conditions. This approach may leverage the effects of cold temperature on mucociliary function, which is not typically explored in standard treatments for lung disease. ^{2 3 9 10 11}

What is the purpose of this trial?

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.

Research Team

Austin Pittman, BSN, RN

Principal Investigator

TriHealth Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Does Heating up Saline for Nasal Irrigation Improve Mucociliary Function in Chronic Rhinosinusitis? [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Saline nasal irrigation for upper respiratory conditions. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Advances in the treatment of pulmonary alveolar proteinosis. [2015]

5. Canada pubmed.ncbi.nlm.nih.gov

The effects of direct instillations of a therapeutic mixture into the tracheobronchial tree. [2018]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Strategies for decreasing contamination of homemade nasal saline irrigation solutions. [2016]

8. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of normal saline instillation and paediatric endotracheal suction: An integrative review. [2019]

9. Switzerland 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. [2023]

10. Brazil pubmed.ncbi.nlm.nih.gov

New Ringer's lactate gel formulation on nasal comfort and humidification. [2022]

11. Switzerland 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. [2023]