3D Printing to Improve Nasal Irrigation Outcome
3D Printing for Topical Nasal Corticosteroid Irrigations: a Randomized Clinical Trial.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Chronic rhinosinusitis (CRS) is one of the most common medical conditions in the US, affecting an estimated 13% of adults, or some 30 million people. It accounts for 12.5 million physician office visits each year and an annual health care expenditure of $5.8 billion (National Health Interview Survey 2009, CDC). Major symptoms include nasal obstruction, facial pain/pressure, nasal discharge, purulence in the nasal cavity, and loss of smell. These symptoms significantly impact patient quality of life, even compared to chronic debilitating diseases such as diabetes and congestive heart failure.
Topical therapies play an integral role in the management of CRS, and high-volume irrigation delivery (e.g., neti pot, squeeze bottles) is more effective for achieving distribution to the sinuses than other topical delivery methods such as nasal sprays, nebulizers, or atomizers. Saline irrigations have been recommended in a number of clinical scenarios, including initial management of CRS and postoperative care. High-volume irrigations have also shown benefits for medication delivery, such as with mupirocin and corticosteroids. However, due to the intricate and variable anatomy of the human nasal airway, the efficacy of topical irrigations is inconsistent and difficult to predict. Previous studies from our group and others have shown that nasal irrigant may not reliably penetrate all sinuses, and the effectiveness varies depending on specific sinuses, head positions, injection angle, pressure, flow rates, and other factors. We currently do not have a clear understanding of the optimal delivery technique(s). In efforts to improve these outcomes, the efficacy of topical irrigation delivery to target sinuses is an area of active research. Yet, investigations have been limited by labor-intensive methodologies, such as cadaver studies or using colored dyes followed by endoscopy to visualize where the irrigation might have reached. Other studies have used irrigations with iodinated contrast followed by computed tomography (CT) scans to determine which sinuses collect contrast material. Similarly, technetium 99m sulfur colloid and fluorescein have also been used as tracers to visualize the distribution of sinus irrigations. These labor-intensive techniques are difficult to apply to a large sample size. They increase patient risk and commonly capture only where the irrigation fluid has been at the end of irrigation, but not the details of irrigation flow paths that would allow us to understand why the irrigation outcomes vary.
From both patients' and clinicians' perspectives, the lack of clear prediction of patient-specific irrigation outcomes can be frustrating, as clinicians prescribe a rigorous daily irrigation routine but have no assurance that what patients are doing is effective. When symptoms fail to improve after courses of irrigation, it is difficult to determine whether the added medication is not working, or the irrigation does not reach clinically relevant targets deep within the sinuses. Many patients and surgeons thus opt for systemic medication or surgery, which increases risk of overmedication, growth of resistant organisms, systemic side effects, and serious risk from surgery.
The purpose of this study was to propose a novel idea: applying three-dimensional (3D)-printing technology based on individual patients' computed tomography (CT) scans to determine an optimal personalized nasal irrigation strategy (head positions, angle of injection, flow rates, etc.).
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Kai Zhao, PhD
- Phone Number: 2673032322
- Email: zhao.1949@osu.edu
Study Contact Backup
- Name: Zachary T. Root, BS
- Phone Number: 6145609257
- Email: zachary.root@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43212
- Recruiting
- The Ohio State University Eye and Ear Institue
-
Contact:
- Kai Zhao, PhD
- Phone Number: 2673032322
- Email: zhao.1949@osu.edu
-
Principal Investigator:
- Kai Zhao, PhD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chronic rhinosinusitis without nasal polyps (CRSsNP) or Chronic rhinosinusitis with nasal polyps (CRSwNP).
Exclusion Criteria:
- Patients with significant nasal polyps (as determined by a clinician) were excluded upfront due to the unlikeness of irrigation penetration regardless of the head position. Patients with significant atopy, cystic fibrosis, granulomatosis with polyangiitis or other connective tissue disorder, and current pregnancy were also excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Control group
The control group (CG) irrigated in the standard FDA consumer-recommended position, defined as leaning forward with a natural ear-to-shoulder head tilt.
|
Patients irrigated their sinuses with once daily 2 mg mometasone using 240 mL NeilMed sinus rinse bottles for 8 weeks.
The only factor that varied between groups was the head position patients irrigated in.
|
|
Experimental: Backfill group
Backfill group (BG) subjects irrigated with a head tilt of 90 degrees ear-to-shoulder and used the nostril closest to the ground.
|
Patients irrigated their sinuses with once daily 2 mg mometasone using 240 mL NeilMed sinus rinse bottles for 8 weeks.
The only factor that varied between groups was the head position patients irrigated in.
|
|
Experimental: Model group
Finally, the model group (MG) irrigated in an optimal position based on their 3D nasal replica.
This patient-specific position was communicated to each MG patient with clear instructions during an in-person training session.
|
Patients irrigated their sinuses with once daily 2 mg mometasone using 240 mL NeilMed sinus rinse bottles for 8 weeks.
The only factor that varied between groups was the head position patients irrigated in.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nasal Obstruction Symptom Evaluation (NOSE) score
Time Frame: completed at baseline and after 8 weeks of treatment.
|
patient-reported outcome measure
|
completed at baseline and after 8 weeks of treatment.
|
|
22-item Sino-Nasal Outcome Test (SNOT-22) score
Time Frame: completed at baseline and after 8 weeks of treatment.
|
patient-reported outcome measure
|
completed at baseline and after 8 weeks of treatment.
|
|
Visual Analogue Scale (VAS) of nasal congestion score
Time Frame: completed at baseline and after 8 weeks of treatment.
|
patient-reported outcome measure
|
completed at baseline and after 8 weeks of treatment.
|
|
Lund-Mackay (LM) score of sinus inflammation.
Time Frame: assessed from CT scans taken at baseline and after 8 weeks of treatment.
|
Objective rating of sinus inflammation
|
assessed from CT scans taken at baseline and after 8 weeks of treatment.
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Albu S. Chronic Rhinosinusitis-An Update on Epidemiology, Pathogenesis and Management. J Clin Med. 2020 Jul 18;9(7):2285. doi: 10.3390/jcm9072285.
- Wormald PJ, Cain T, Oates L, Hawke L, Wong I. A comparative study of three methods of nasal irrigation. Laryngoscope. 2004 Dec;114(12):2224-7. doi: 10.1097/01.mlg.0000149463.95950.c5.
- Piromchai P, Puvatanond C, Kirtsreesakul V, Chaiyasate S, Suwanwech T. A multicenter survey on the effectiveness of nasal irrigation devices in rhinosinusitis patients. Laryngoscope Investig Otolaryngol. 2020 Nov 16;5(6):1003-1010. doi: 10.1002/lio2.497. eCollection 2020 Dec.
- Lepley TJ, Kim K, Ardizzone M, Kelly KM, Otto BA, Zhao K. 3D Printing as a Planning Tool to Optimize Sinonasal Irrigation. Ann Otol Rhinol Laryngol. 2023 Nov;132(11):1306-1313. doi: 10.1177/00034894221149242. Epub 2023 Jan 26.
- Zhao K, Kim K, Craig JR, Palmer JN. Using 3D printed sinonasal models to visualize and optimize personalized sinonasal sinus irrigation strategies. Rhinology. 2020 Jun 1;58(3):266-272. doi: 10.4193/Rhin19.314.
- Root ZT, Lepley TJ, Kim K, Schneller AR, Zhao S, Wen R, Formanek VL, Sussman SM, Lee JS, Odeh A, Wei L, Kelly KM, Otto BA, Zhao K. Optimizing Corticosteroid Sinonasal Irrigation Outcomes Through 3D Printing: A Randomized Pilot Clinical Trial. OTO Open. 2024 Oct 16;8(4):e70036. doi: 10.1002/oto2.70036. eCollection 2024 Oct-Dec.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2020H0068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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