COPD, Severe Early-OnsetNCT06215391
Customized Masks in Non-Invasive Mechanical Ventilation
A study testing 3d printed mask in people with COPD, Severe Early-Onset and Ventilatory Failure, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
Trial summary
In non-invasive mechanical ventilation (NIMV), the interface is the primary determinant of success, as adherence and quality of therapy mainly depend on it. The aim of this study is to investigate the usefulness of a customised mask approach to minimise leakage and upper airway obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Severe Early-Onset, Ventilatory Failure, Als
- What is being tested?
- 3d printed mask
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 10 Dec 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient enrolled in the Home Mechanical Ventilation (HMV) program.
- Adherence of >4 hours per day.
- In the case of COPD, inspiratory pressures >18 cmH2O.
- Users of a Resmed HMV device to standardize and facilitate the analysis of the respirator log.
- Commercial masks (MC) in optimal condition, as assessed by the mechanical ventilation unit responsible during outpatient ventilation consultations.
- Presence of residual leaks (>5 LPM on average according to the respirator log - ResScan, unintentional leaks, with intentional leaks excluded by software).
Who cannot join
- Patients with tracheostomy or scheduled for tracheostomy.
- Patients on a waiting list for lung transplantation.
- Patients using HMV devices from manufacturers other than ResMed.
- Users who alternate between various MC models, where homogeneity in interface use cannot be assured.
- Refusal to provide consent.
- Patients with documented allergies to components of medical-grade silicone used in the production of M3D.
- Exacerbations requiring hospitalization or changes in medication or the respirator in the last 3 months.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitarios 12 de Octubre
Madrid, Madrid, 28041
Javier Sayas, +34913908492, javier.sayas@salud.madrid.org
About this study
Official title: Customized Masks in Non-Invasive Mechanical Ventilation: An Innovative Approach Through 3D Printing
In non-invasive mechanical ventilation (NIMV), the interface is the primary determinant of success, as adherence and quality of therapy mainly depend on it. The aim of this study is to investigate the usefulness of a customised mask approach to minimise leakage and upper airway obstruction. It will focus on ventilator registries and changes in the way they can be corrected with these customised masks.
The process involves 3D face scanning and dedicated computer-aided design. The processing and manufacturing of the masks is based on additive manufacturing through 3D printing.
Read the detailed description
In non-invasive mechanical ventilation (NIMV), the interface is the primary determinant of success, as adherence and the quality of therapy depend mainly on it. A deteriorated or inadequate mask can lead to unintentional leaks or jaw and tongue displacements, thereby increasing obstructive events in the upper airway. There is a growing interest in the use of personalized masks designed using facial scanning and 3D printing technology. Previous studies have demonstrated their effectiveness in complex patients, such as premature neonates, and healthy individuals, successfully reducing leaks and skin sores.
The aim of the project is to demonstrate the utility of a 3D-printed, customised mask to improve the quality of ventilation, primarily by reducing leaks and mask-related obstructions in adult patients receiving home NIMV. Two usage periods of NIMV will be studied, one month with a personalized mask created through 3D printing (M3D) and another month with a commercial mask (MC). The primary variable under study will be the difference in leak levels between M3D and MC throughout the study month with each of them. Variables derived from respiratory polygraphy, performed with each mask, will also be included, in addition to the patient's experience.
- Being tested
- 3d printed mask
- Keywords
- non invasive ventilation, 3d printed mask
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Severe Early-Onset, Hypoventilation, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d printed maskDevice
- Concurrent, prospective, non-randomized inclusion, cross-over design. A minimum of 6 patients will be included for each group, COPD, and ALS.
- T0: Patient enrollment (informed consent signing), retrospective review of the respirator log (1 month prior), variable extraction (extracting EDF files from the respirator log and data obtained from ResScan).
- During the first week, a 3D scan of the patient's face will be conducted, and the personalized 3D-printed mask (M3D) will be manufactured.
- Once ready, the mask will be fitted, and the 1-month evaluation period will begin (T1: after 1 month of M3D use). The respirator card will be downloaded in the same manner as at T0, and a respiratory polygraphy (RP) will be scheduled.
- T2: At the end of the study month, the patient will resume using a similar MC, which is new and well-fitted. After one month of MC use, the respirator log will be reviewed, and a new RP will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| commercial mask | No intervention | Noninvasive ventilation delivered through a conventional mask as usual care |
| 3d printed mask | Experimental | The customized mask will be obtained by merging the scanned surface with the base mask design using CAD 3D SolidWorks software, also available in the unit. In patients with edentulism, leak areas will be evaluated without dental prostheses.
3D Printing
Personalized oronasal masks will be manufactured following this procedure:
* Design and manufacture of molds for each type of base mask and the personalized mold of the scanned surface, using stereolithography technology with suitable biocompatible resin such as BioMed Clear or White from FormLABS.
* Manual injection of a biocompatible resin with a Shore A hardness of 18, such as SORTA-Clear™ 18, by joining the two molds. This Shore A hardness will provide appropriate elasticity for this type of mask, perfectly adapting to each patient's unique facial characteristics. Receives: Device: 3d printed mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modifications in leaks
Median daily leakage over the study month with each mask (MC and M3D), determined from the respirator log, extracted using ResScan® (Resmed®) software.
Measured: 1 month
Secondary outcomes (4)
Apnea Hypopnea Index
- Mean AHI over the study month with each mask, automatically recorded by the respirator software (ResScan®) for each mask period. IAH /AHI ranges from 0 to over 30 events per hour. A threshold of <10 is usually considered a sign of adequate ventilation. A minimal decrease of 20% will be considered clinically relevant
Measured: 1 month
Comfort
- Patient comfort at the end of the one-month period with each mask (Likert scale). Likert scale ranges from Strongly uncomfortable to strongly comfortable
Measured: 1 month
Adherence
- Adherence measured by the mean device usage (hours of use/days of use) and total days of use in 1 month (T0 vs. T1).
Measured: 1 month
• Polygraphic variables
.1 Asynchrony Index
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start10 Dec 2023
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD, Severe Early-OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Conceptual Hypothesis: The use of personalized 3D-printed masks may reduce leaks, adverse effects in the form of skin lesions, and the percentage of upper airway obstructive events in two distinct populations: patients with ALS and patients with COPD requiring inspiratory pressures greater than 22 cmH2O. Operational Hypothesis: The automatic AHI and the median leaks over 1 month are lower when the patient uses the custom-fit 3D-printed mask (M3D) compared to when they use the commercial mask (MC) that was prescribed. Statistical Hypothesis: H0: There are no differences in the median leaks over 1 month (and AHI) between commercial masks (MC) and personalized 3D-printed masks (M3D). H1: The median leaks are significantly lower during the month of using the personalized mask (M3D) than during the use of the commercial mask.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215391
- Sponsor's protocol ID
- 23/478
- Status last verified
- Jan 2024
- First submitted
- 10 Nov 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lujan M, Florez P, Pomares X. What Circuits, Masks and Filters Should Be Used in Home Non-Invasive Mechanical Ventilation. J Clin Med. 2023 Apr 4;12(7):2692. doi: 10.3390/jcm12072692.
PubMed 37048774
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Masks in Non-Invasive Mechanical Ventilation: An Innovative Approach Through 3D Printing
- ClinicalTrials.gov ID
- NCT06215391
- Acronym / sponsor ID
- 23/478
- Keywords
- non invasive ventilation, 3d printed mask
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In non-invasive mechanical ventilation (NIMV), the interface is the primary determinant of success, as adherence and quality of therapy mainly depend on it. The aim of this study is to investigate the usefulness of a customised mask approach to minimise leakage and upper airway obstruction. It will focus on ventilator registries and changes in the way they can be corrected with these customised masks.
The process involves 3D face scanning and dedicated computer-aided design. The processing and manufacturing of the masks is based on additive manufacturing through 3D printing.
Detailed description
In non-invasive mechanical ventilation (NIMV), the interface is the primary determinant of success, as adherence and the quality of therapy depend mainly on it. A deteriorated or inadequate mask can lead to unintentional leaks or jaw and tongue displacements, thereby increasing obstructive events in the upper airway. There is a growing interest in the use of personalized masks designed using facial scanning and 3D printing technology. Previous studies have demonstrated their effectiveness in complex patients, such as premature neonates, and healthy individuals, successfully reducing leaks and skin sores.
The aim of the project is to demonstrate the utility of a 3D-printed, customised mask to improve the quality of ventilation, primarily by reducing leaks and mask-related obstructions in adult patients receiving home NIMV. Two usage periods of NIMV will be studied, one month with a personalized mask created through 3D printing (M3D) and another month with a commercial mask (MC). The primary variable under study will be the difference in leak levels between M3D and MC throughout the study month with each of them. Variables derived from respiratory polygraphy, performed with each mask, will also be included, in addition to the patient's experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Conceptual Hypothesis: The use of personalized 3D-printed masks may reduce leaks, adverse effects in the form of skin lesions, and the percentage of upper airway obstructive events in two distinct populations: patients with ALS and patients with COPD requiring inspiratory pressures greater than 22 cmH2O. Operational Hypothesis: The automatic AHI and the median leaks over 1 month are lower when the patient uses the custom-fit 3D-printed mask (M3D) compared to when they use the commercial mask (MC) that was prescribed. Statistical Hypothesis: H0: There are no differences in the median leaks over 1 month (and AHI) between commercial masks (MC) and personalized 3D-printed masks (M3D). H1: The median leaks are significantly lower during the month of using the personalized mask (M3D) than during the use of the commercial mask.
| Arm | Type | Receives |
|---|---|---|
| commercial mask | No intervention | –Noninvasive ventilation delivered through a conventional mask as usual care |
| 3d printed mask | Experimental | Device: 3d printed maskThe customized mask will be obtained by merging the scanned surface with the base mask design using CAD 3D SolidWorks software, also available in the unit. In patients with edentulism, leak areas will be evaluated without dental prostheses. 3D Printing Personalized oronasal masks will be manufactured following this procedure: * Design and manufacture of molds for each type of base mask and the personalized mold of the scanned surface, using stereolithography technology with suitable biocompatible resin such as BioMed Clear or White from FormLABS. * Manual injection of a biocompatible resin with a Shore A hardness of 18, such as SORTA-Clear™ 18, by joining the two molds. This Shore A hardness will provide appropriate elasticity for this type of mask, perfectly adapting to each patient's unique facial characteristics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient enrolled in the Home Mechanical Ventilation (HMV) program.
- Adherence of >4 hours per day.
- In the case of COPD, inspiratory pressures >18 cmH2O.
- Users of a Resmed HMV device to standardize and facilitate the analysis of the respirator log.
- Commercial masks (MC) in optimal condition, as assessed by the mechanical ventilation unit responsible during outpatient ventilation consultations.
Key exclusion criteria (7 listed)
- Patients with tracheostomy or scheduled for tracheostomy.
- Patients on a waiting list for lung transplantation.
- Patients using HMV devices from manufacturers other than ResMed.
- Users who alternate between various MC models, where homogeneity in interface use cannot be assured.
- Refusal to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3d printed mask* Concurrent, prospective, non-randomized inclusion, cross-over design. A minimum of 6 patients will be included for each group, COPD, and ALS. * T0: Patient enrollment (informed consent signing), retrospective review of the respirator log (1 month prior), variable extraction (extracting EDF files from the respirator log and data obtained from ResScan). * During the first week, a 3D scan of the patient's face will be conducted, and the personalized 3D-printed mask (M3D) will be manufactured. * Once ready, the mask will be fitted, and the 1-month evaluation period will begin (T1: after 1 month of M3D use). The respirator card will be downloaded in the same manner as at T0, and a respiratory polygraphy (RP) will be scheduled. * T2: At the end of the study month, the patient will resume using a similar MC, which is new and well-fitted. After one month of MC use, the respirator log will be reviewed, and a new RP will be conducted. | Device | 3d printed mask |
Primary outcome
Modifications in leaks
Time frame: 1 month
Median daily leakage over the study month with each mask (MC and M3D), determined from the respirator log, extracted using ResScan® (Resmed®) software.
4 secondary outcomes
Apnea Hypopnea Index
Time frame: 1 month
Comfort
Time frame: 1 month
Adherence
Time frame: 1 month
• Polygraphic variables
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Background: PubMed 37048774Lujan M, Florez P, Pomares X. What Circuits, Masks and Filters Should Be Used in Home Non-Invasive Mechanical Ventilation. J Clin Med. 2023 Apr 4;12(7):2692. doi: 10.3390/jcm12072692.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3d printed mask in people with COPD, Severe Early-Onset and Ventilatory Failure, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Gonzalez Ramos (913908492, lauragramos@hotmail.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modifications in leaks (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06215391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.