Airway Splint for Bronchomalacia

Overseen By Andrea S Les, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Tracheal stenosis, Single-lung anatomy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Hospital stay

35 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn if a three-dimensional (3D) printed airway splint device made to hold open a collapsing airway is a safe and effective treatment of Tracheobronchomalacia (TBM) in children. The airway splint is bioresorbable, meaning the child's body will absorb the splint over about five years.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment Bioresorbable Tracheobronchial Splint for Bronchomalacia?

Research shows that 3D-printed, bioresorbable airway splints have been effective in treating severe airway collapse in children, with improvements in breathing and no major complications. These splints help keep the airway open and allow it to grow, providing a safe and reliable treatment option. ^{1 2 3 4 5}

How is the Bioresorbable Tracheobronchial Splint treatment different from other treatments for bronchomalacia?

The Bioresorbable Tracheobronchial Splint is unique because it is a 3D-printed, patient-specific device that supports the airway externally and gradually dissolves in the body over time, unlike traditional treatments that may require permanent implants or more invasive surgeries. This splint is designed to adapt to the patient's growth and is made from materials that safely break down into carbon dioxide and water. ^{1 2 3 4 6}

Research Team

Richard G Ohye, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for children with Tracheobronchomalacia (TBM), a condition where the airway collapses and makes breathing difficult. The child's body should be able to absorb bioresorbable materials over time.

Inclusion Criteria

My airways are at least 50% blocked, confirmed by a CT scan.

I have a condition where my airways collapse by more than half.

Subjects must have a life expectancy of at least 2 years, exclusive of TBM

Exclusion Criteria

Subject has single-ventricle cardiac anatomy

I have a severe narrowing in my windpipe.

I have a permanent airway stent or recently had one removed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo pre-operative assessments including Pediatric Quality of Life Inventory Infant Scales (PedsQL)

Up to 4 weeks

Treatment

Participants are admitted to the hospital for the assessment and placement of the bioresorbable tracheobronchial splint

Hospital stay

Initial Follow-up

Participants are monitored for splint patency and device-related complications

6 months

Regular visits for monitoring

Extended Follow-up

Long-term follow-up to assess Pediatric Quality of Life and device-related complications

Up to 5 years

Treatment Details

Interventions

• Bioresorbable Tracheobronchial Splint

Trial Overview The study is testing a 3D printed, bioresorbable airway splint designed to support a collapsing airway in children with TBM. It aims to determine if this treatment is safe and effective.

Participant Groups

Group I: Bioresorbable Tracheobronchial Splint Experimental Treatment 1 Intervention

Participants are admitted to the hospital for this assessment and placement of the splint.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Materialise

Industry Sponsor

Trials

4

Recruited

70+

Findings from Research

In a study of 5 pediatric patients with severe tracheomalacia or tracheobronchomalacia, the use of bioabsorbable airway supportive devices (ASD) led to successful weaning from respiratory support in 4 out of 5 cases, demonstrating their potential efficacy in critical airway management.

Pre-operative 3D airway modeling was crucial for optimizing the placement of sutures on the ASDs, which helped improve airway patency and overall treatment outcomes, highlighting the importance of careful planning in complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External airway splint placement for severe pediatric tracheobronchomalacia. Brooks, KA., Lai, AY., Tucker, SJ., et al.[2023]

In a study involving 14 children with severe airway collapse, the use of novel external bioresorbable splints provided effective temporary support, allowing for airway growth while addressing structural issues.

Most patients showed improvement, with 4 requiring no further interventions and several others needing less intensive mechanical ventilation, indicating the splints' potential in managing severe tracheobronchomalacia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with bioresorbable splints for treatment of airway collapse in a pediatric population. Kamran, A., Smithers, CJ., Baird, CW., et al.[2022]

In a case series of 15 critically ill children with severe tracheobronchomalacia, the use of 3D-printed bioresorbable airway splints led to significant improvements in respiratory support, with a median reduction in positive end-expiratory pressure (PEEP) of -2.5 cm H2O after implantation.

At a median follow-up of 8.5 months, most surviving subjects were able to live at home, with notable advancements in their respiratory independence, including one child being decannulated and others reducing their reliance on ventilators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D-printed, externally-implanted, bioresorbable airway splints for severe tracheobronchomalacia. Les, AS., Ohye, RG., Filbrun, AG., et al.[2020]

A study involving nine infants with severe tracheomalacia showed that personalized 3D-printed bioresorbable airway external splints effectively relieved respiratory symptoms without complications, supporting their safety and efficacy as a treatment option.

The splints provided support for at least 6 months and were designed to degrade safely over 2-3 years, allowing for airway growth while preventing collapse, making them a promising alternative to traditional surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized 3D-Printed Bioresorbable Airway External Splint for Tracheomalacia Combined With Congenital Heart Disease. Yu, D., Peng, W., Mo, X., et al.[2022]

A novel treatment using 3D-printed, patient-specific, bioresorbable airway splints has been investigated in 15 critically ill children with severe tracheobronchomalacia, showing promising results with 12 long-term survivors after a median follow-up of 8.5 months.

This innovative approach offers a potential alternative to more invasive therapies like tracheostomy and mechanical ventilation, highlighting its efficacy in managing severe cases of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced Therapies for Severe Tracheobronchomalacia: A Review of the Use of 3D-Printed, Patient-Specific, Externally Implanted, Bioresorbable Airway Splints. Sood, V., Green, GE., Les, A., et al.[2021]

A surgical procedure using a silastic reinforced marlex mesh splint was successfully performed on 4 children (3 with tracheomalacia and 1 with bronchomalacia) to support their collapsing airways, with no complications reported.

The splint effectively eliminated symptoms of airway collapse in all patients, suggesting it is a viable treatment option for cases where other methods have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of segmental tracheomalacia and bronchomalacia by implantation of an airway splint. Filler, RM., Buck, JR., Bahoric, A., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

External airway splint placement for severe pediatric tracheobronchomalacia. [2023]

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

Experience with bioresorbable splints for treatment of airway collapse in a pediatric population. [2022]

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

3D-printed, externally-implanted, bioresorbable airway splints for severe tracheobronchomalacia. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized 3D-Printed Bioresorbable Airway External Splint for Tracheomalacia Combined With Congenital Heart Disease. [2022]

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

Advanced Therapies for Severe Tracheobronchomalacia: A Review of the Use of 3D-Printed, Patient-Specific, Externally Implanted, Bioresorbable Airway Splints. [2021]

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

Treatment of segmental tracheomalacia and bronchomalacia by implantation of an airway splint. [2019]