New Full-Face Mask for Respiratory Failure

Recruiting at 2 trial locations

Overseen By James Miller

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fisher and Paykel Healthcare

Disqualifiers: Infectious isolation, Claustrophobia, Pneumothorax, others

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

Compensation: Varies

Number of Visits: 2

Duration: 90 minutes

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new full-face mask with expiratory washout can improve breathing for patients using non-invasive ventilation (NIV) due to respiratory failure. Researchers will compare this new mask to traditional masks to assess its impact on the volume of air patients inhale and exhale, as well as other breathing measurements. The trial includes three different tests using either the investigational mask (known as the Vela Mask) or conventional masks. Individuals already using NIV for acute breathing issues, such as low oxygen or high carbon dioxide levels, may be suitable for this study. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future respiratory treatments.

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

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but please confirm with the study team.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing different masks for non-invasive ventilation, so it's best to ask the study team for guidance.

What prior data suggests that this new full-face mask is safe for patients with respiratory failure?

Research shows that the new mask being tested clears exhaled air more effectively than regular masks. This improvement could ease breathing for those using non-invasive ventilation (NIV).

Regarding safety, earlier studies found no major issues or side effects with the new mask, suggesting it is safe for patients. However, these results come from early studies, and further research is necessary to confirm its safety for a broader population. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this investigational mask for respiratory failure because it includes an expiratory washout feature that could improve patient comfort and ventilation efficiency. Traditional masks often struggle with removing exhaled carbon dioxide effectively, but this new mask is designed to address that issue directly. By potentially reducing carbon dioxide buildup, the mask could enhance breathing support and reduce the risk of complications for patients using non-invasive ventilation. This innovative approach sets it apart from conventional masks, which typically rely on simpler venting systems.

What evidence suggests that this investigational mask with expiratory washout is effective for respiratory failure?

This trial will compare the investigational mask with expiratory washout to conventional masks. Research shows that the new mask may help people breathe better during non-invasive ventilation (NIV). Studies have found that this mask clears carbon dioxide more effectively than regular masks. In one study, a participant using the new mask experienced a significant drop in carbon dioxide levels, unlike with the regular mask. The mask appears to improve airflow, aiding overall breathing. These findings suggest that the mask might assist people with breathing problems. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for patients with acute respiratory failure, either hypercapnic (high carbon dioxide levels) or hypoxemic (low oxygen levels), who are using non-invasive ventilation. They must fit the investigational mask and not be expected to need intubation within the next two hours. It's also for those at high risk of needing re-intubation post-extubation.

Inclusion Criteria

I need a high-flow nasal oxygen device for my breathing issue without having high CO2 levels.

I recently had trouble breathing with high CO2 levels or was at risk of needing a breathing tube again.

This is applicable solely to hypoxemic patients.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Measurement

Participants receive oxygen therapy via nasal cannula for 15 minutes, during which baseline measurements of physiological parameters are recorded

15 minutes

1 visit (in-person)

Treatment

Participants undergo three 30-minute periods of non-invasive ventilation with different masks in a randomized order

90 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Investigational Mask with Expiratory Washout

Trial Overview The study compares a new full-face mask with expiratory washout to conventional masks in non-invasive ventilation settings. Patients will try three different setups: an investigational mask, a single-limb conventional mask, and a dual-limb conventional mask, in random order to see which helps breathing more effectively.

How Is the Trial Designed?

Group I: Single-limb non-invasive ventilation with expiratory washout Experimental Treatment 1 Intervention

In a random order, 30 minute period of non-invasive ventilation using the investigational mask, a vented full-face mask with expiratory washout

Group II: Single-limb non-invasive ventilation Active Control 1 Intervention

In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT077 or equivalent)

Group III: Dual-limb non-invasive ventilation Active Control 1 Intervention

In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT076 or equivalent)

Who Is Running the Clinical Trial?

Fisher and Paykel Healthcare

Lead Sponsor

Trials

127

Recruited

11,000+

Dr. Justin Vaughan

Fisher and Paykel Healthcare

Chief Medical Officer since 2024

MD from the University of Auckland

Lewis Gradon

Fisher and Paykel Healthcare

Chief Executive Officer since 2016

Bachelor of Science in Physics from the University of Auckland, New Zealand

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

1

Recruited

30+

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Collaborator

Trials

26

Recruited

6,300+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

Published Research Related to This Trial

In a study involving 40 patients undergoing minor surgeries, it was found that the fraction of inspired carbon dioxide (FiCO2) remained similar across different oxygen flow rates (3, 4, 5, and 6 L/min) when using a Hudson mask, indicating consistent performance regardless of flow rate.

A strong positive correlation between respiratory rate (RR) and FiCO2 was observed at a flow rate of 3 L/min, suggesting that at lower flow rates, increased breathing rates can lead to higher levels of carbon dioxide in the inhaled air, but this remains within safe physiological limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capnographic Analysis of Minimum Mandatory Flow Rate for Hudson Face Mask: A Randomized Double-blind Study. Kurhekar, P., Prasad, TK., Rajarathinam, B., et al.[2020]

Mask CPAP is a safe and effective treatment for patients with mild-to-moderate respiratory failure, specifically those with a PaO2/FIO2 ratio of less than 300, as it alleviates hypoxemia and reduces the work of breathing.

Continuous application of mask CPAP has been shown to effectively treat atelectasis, although its effectiveness for other conditions like asthma needs more research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mask CPAP: state of the art. Branson, RD., Hurst, JM., DeHaven, CB.[2004]

A modified total face mask with a two-limb ventilation circuit significantly reduces rebreathing of CO2 compared to a standard mask, making it a safer option for noninvasive ventilation (NIV).

The use of a 15 L/min bias flow with the modified mask further decreases rebreathing, suggesting that this design could improve the efficacy of NIV in treating respiratory failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Face Mask Design and Bias Flow on Rebreathing During Noninvasive Ventilation. Signori, D., Bellani, G., Calcinati, S., et al.[2020]

In a five-year analysis of 1,559 healthy volunteers across 142 phase I studies, the overall incidence of adverse events (AEs) was 8.8%, with most AEs being mild or moderate in severity, indicating that while AEs are common, they are generally not severe.

The incidence of AEs was significantly higher in multiple-dose studies compared to single-dose trials, highlighting the importance of study design in assessing the safety profile of active drugs, with a notable increase in AEs on the first day of drug administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. Lutfullin, A., Kuhlmann, J., Wensing, G.[2019]

The tube tip in pharynx (TTIP) ventilation technique successfully restored ventilation in all four cases of failed facemask ventilation during anesthesia induction, demonstrating its efficacy as a simple, single-handed method.

No complications, such as gastric insufflation, were reported, indicating that TTIP ventilation is a safe alternative for anesthetists to use when traditional mask ventilation fails.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tube tip in pharynx (TTIP) ventilation: simple establishment of ventilation in case of failed mask ventilation. Kristensen, MS.[2018]

A total of 189 Post-Authorization Safety Study (PASS) protocols were submitted to the European Medicines Agency (EMA) from July 2012 to July 2015, with half of them registered in the ENCePP electronic register, indicating a significant effort to monitor drug safety post-approval.

The review highlighted that many PASS protocols faced methodological and feasibility concerns, with 65% lacking a comparator and 58% relying on secondary data sources, suggesting a need for improved study design to enhance the reliability of safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight. Engel, P., Almas, MF., De Bruin, ML., et al.[2021]

The article introduces a new design for facial masks that can effectively protect surgeons from aerosol infections during short airway procedures, addressing concerns about the quality of personal protective equipment (PPE) during the ongoing pandemic.

This novel mask design is presented as a viable alternative for managing airway emergencies, especially in situations where high-quality PPE is not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Least Expensive Facial Mask Against Corona Virus for Short Airway Procedures Generating Aerosol. Singh, V., Chaubey, K., Onkar, V., et al.[2022]

Continuous safety assessment of new drugs is crucial both before and after they are marketed, especially in Japan where postmarketing studies often overlook patient exposure levels.

Simulations indicate that underestimating adverse event rates can occur if the risk of these events increases over time and if patient drop-out rates are high, highlighting the need for careful study design to accurately capture safety data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observation of time-dependent adverse events and the influence of drop-out thereon in long-term safety studies--simulation study under the current practice of post-marketing safety evaluation in Japan. Narukawa, M., Yafune, A., Takeuchi, M.[2004]

The DELTA network study evaluated the safety of devices used in over 23,000 percutaneous coronary interventions from 2008 to 2012, revealing that the Perclose vascular closure device was associated with a significantly higher risk of minor vascular complications compared to alternative devices, with a relative risk of 4.14.

This study highlights the effectiveness of automated prospective safety surveillance in providing timely assessments of medical device safety, as it successfully identified safety alerts based on real-time data analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance. Kumar, A., Matheny, ME., Ho, KK., et al.[2020]

A simulation study suggests that longer follow-up periods for patients, even with smaller sample sizes, are crucial for accurately characterizing delayed adverse events (AEs) in post-marketing safety studies.

For AEs that occur shortly after treatment, a larger number of patients with a shorter study duration is more effective, highlighting the need for careful planning in study design to ensure reliable safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A note on post-marketing safety study design to characterise time-dependent adverse events. Narukawa, M., Yafune, A.[2007]

In a study of 548 patients with postoperative pneumonia, those without serious underlying diseases treated with 1 g of cefotaxime twice daily achieved a 100% clinical cure rate, with all isolated pathogens eradicated.

For patients with severe infections or underlying conditions receiving 2 g of cefotaxime, the treatment showed a high overall clinical success rate of 98.4%, supporting cefotaxime as an effective alternative for treating nosocomial pneumonia in surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of cefotaxime twice daily for the therapy of postoperative pneumonia. The German Cefotaxime Study Group. Bruch, HP., Kujath, P.[2019]

Moxalactam was highly effective in treating lower respiratory tract infections in a study of 40 patients, with no treatment failures reported, although two patients died from unrelated causes during or shortly after therapy.

All bacterial isolates tested, including common pathogens like Streptococcus pneumoniae and Haemophilus influenzae, were found to be susceptible to moxalactam, indicating its strong antibacterial properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy of lower respiratory tract infections with moxalactam. Lentino, JR., Rytel, MW., Moore, E.[2021]

The MS-2 system showed a high frequency of very major errors in susceptibility testing for cefotaxime (32%) and moxalactam (52%) in 111 Pseudomonas aeruginosa isolates, indicating unreliable results for these antibiotics.

Further testing confirmed that these errors were consistent across additional isolates from another hospital, suggesting that the MS-2 system should not be used for determining resistance to these third-generation cephalosporins in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

False-susceptible results from the MS-2 system used for testing resistant Pseudomonas aeruginosa against two third-generation cephalosporins, moxalactam and cefotaxime. Stone, LL., Jungkind, DL.[2021]

In a study comparing the in vitro effectiveness of four new beta-lactam antibiotics against 744 clinical isolates of gram-negative bacteria, cefoperazone showed the strongest activity against Pseudomonas aeruginosa, while cefotaxime was the least effective.

Aminoglycosides demonstrated superior in vitro activity against Pseudomonas aeruginosa compared to the beta-lactam agents, indicating they may be more effective for treating infections caused by this specific bacteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative in vitro activity of moxalactam, cefotaxime, cefoperazone, piperacillin, and aminoglycosides against gram-negative bacilli. Kurtz, TO., Winston, DJ., Hindler, JA., et al.[2021]

The Vitek System (GNS-107 card) showed a high error rate of 25.3% when testing cefepime against Pseudomonas aeruginosa, including 5.3% false resistance and 20.0% minor errors, indicating reliability issues.

Compared to other testing methods, the Vitek System reported a significantly higher resistance rate (14.0%) for cefepime than the consensus rate (4.3%), suggesting that alternative testing methods should be used for accurate susceptibility assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Vitek system to accurately test the susceptibility of Pseudomonas aeruginosa clinical isolates against cefepime. Jones, RN., Biedenbach, DJ., Marshall, SA., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39964871/

Efficacy of Noninvasive Ventilation With Expiratory ... This study compared the performance and comfort of a novel investigational mask with expiratory washout with a conventional mask during NIV therapy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06007495

Pilot Physiological Evaluation of an Investigational Mask ... The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on ...

3. liebertpub.com liebertpub.com/doi/full/10.1089/respcare.11876

Efficacy of Noninvasive Ventilation With Expiratory ... Conclusions. This pilot study found that, when compared with a conventional pronasal mask, the investigational mask seemed to improve expiratory washout of the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05964244

Study Details | NCT05964244 | Impact of Noninvasive With ... This study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1089/respcare.11876?icid=int.sj-full-text.similar-articles.5

Efficacy of Noninvasive Ventilation With Expiratory ... One participant experienced a reduction in P tcCO 2 of ≥8 mm Hg with the investigational mask but not with the conventional mask, and one participant ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39134364/

Efficacy of Noninvasive Ventilation With Expiratory ... This study compared the performance and comfort of a novel investigational mask with expiratory washout with a conventional mask during NIV therapy.