Noninvasive Ventilation Modes for Hypercapnic Respiratory Failure

Overseen By Sara Velichkovikj

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Pregnancy, Hypotension, Chronic tracheostomy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5-7 days

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which noninvasive ventilation method—Average Volume-Assured Pressure Support (AVAPS) or Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)—is more effective for people with hypercapnic respiratory failure, a condition where breathing fails to remove enough carbon dioxide. Both methods assist patients by using a machine that supports breathing without inserting a tube into the windpipe. The researchers aim to assess whether AVAPS can reduce the time patients spend in intensive care or under close monitoring. Suitable candidates for this trial include those admitted to Lenox Hill Hospital with hypercapnic respiratory failure who require noninvasive ventilation. As an unphased trial, this study offers patients the chance to contribute to important research that could enhance future treatment options.

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's best to discuss this with the study team or your doctor.

What prior data suggests that these noninvasive ventilation modes are safe for hypercapnic respiratory failure?

Previous studies have shown that both Average Volume-Assured Pressure Support (AVAPS) and Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) are safe for individuals with breathing problems due to high carbon dioxide levels. Research indicates that AVAPS improves blood gas levels, crucial for breathing, and enhances quality of life over six months. One study found AVAPS to be as safe and effective as BIPAP S/T in emergency situations.

For BIPAP S/T, studies have demonstrated its effectiveness and safety for individuals with breathing issues, especially compared to other aids like CPAP. Both AVAPS and BIPAP S/T are commonly used and well-tolerated, rarely causing serious side effects. This makes both options safe choices for managing breathing issues linked to excess carbon dioxide in the blood. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for noninvasive ventilation modes like Average Volume-Assured Pressure Support (AVAPS) and Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) for hypercapnic respiratory failure because these methods offer personalized respiratory support. Unlike traditional ventilation, which can be one-size-fits-all, AVAPS automatically adjusts the pressure to maintain a consistent air volume, adapting to the patient’s needs in real-time. Meanwhile, BIPAP S/T provides timed breathing assistance that can help patients who struggle to breathe spontaneously. This trial aims to show how these tailored approaches might provide better comfort and effectiveness compared to standard ventilation techniques.

What evidence suggests that these ventilation modes are effective for hypercapnic respiratory failure?

This trial will compare two noninvasive ventilation modes for hypercapnic respiratory failure: Average Volume-Assured Pressure Support (AVAPS) and Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T). Research has shown that AVAPS effectively treats sudden breathing problems in people with COPD, improving key lung function measures. Studies also indicate that AVAPS can enhance exercise ability and quality of life over time. BIPAP S/T effectively lowers carbon dioxide levels in the blood for patients with breathing difficulties. However, some studies suggest that AVAPS might achieve this more efficiently than BIPAP. Both treatments are safe and effective, but ongoing research in this trial is directly comparing their effectiveness. ^{1 3 5 6 7}

Who Is on the Research Team?

Margarita Oks, MD

Principal Investigator

Lenox Hill Hospital/Northwell Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with hypercapnic respiratory failure who need noninvasive ventilation. They must consent to study procedures and be available throughout the study. Excluded are those without spontaneous breathing, pregnant women, intubated patients, individuals unable to clear airways or at risk of aspiration.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

Admitted to Lenox Hill Hospital medical intensive care unit or telemetry unit

I was diagnosed with too much carbon dioxide in my blood when admitted.

Exclusion Criteria

I am at risk of inhaling food or liquid into my lungs.

I have low blood pressure.

I struggle to breathe or clear my throat properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to receive either AVAPS or BIPAP S/T mode during their hospitalization

5-7 days

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including normalization of pH and need for intubation

1 week

Long-term follow-up

Subgroup analysis and monitoring of outcomes such as ICU stay and PaCO2 differences

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Average Volume-Assured Pressure Support (AVAPS)
• Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T)

Trial Overview

The study compares two noninvasive ventilation methods: AVAPS and BIPAP S/T in treating hypercapnic respiratory failure. It aims to see if AVAPS reduces ICU or telemetry stay compared to BIPAP S/T, which is a standard care approach.

How Is the Trial Designed?

Group I: Average Volume-Assured Pressure Support (AVAPS) Active Control 1 Intervention

Average Volume-Assured Pressure Support (AVAPS) setting on the noninvasive ventilator. The exact AVAPS setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response.

Group II: Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) Active Control 1 Intervention

Bilevel Positive Airway Pressure Spontaneous Timed (BIPAP S/T) setting on the noninvasive ventilator. The exact BIPAP S/T setting will be titrated by the clinical team involved directly in the patient's care based on patient comfort and clinical response.

Average Volume-Assured Pressure Support (AVAPS) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as AVAPS for:

• Hypercapnic respiratory failure
• Chronic obstructive pulmonary disease (COPD)
• Obesity hypoventilation syndrome (OHS)
• Neuromuscular disease (NMD)

Approved in United States as AVAPS for:

• Hypercapnic respiratory failure
• Chronic obstructive pulmonary disease (COPD)
• Obesity hypoventilation syndrome (OHS)
• Neuromuscular disease (NMD)

Approved in Canada as AVAPS for:

• Hypercapnic respiratory failure
• Chronic obstructive pulmonary disease (COPD)
• Obesity hypoventilation syndrome (OHS)
• Neuromuscular disease (NMD)

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

In a study of 100 patients with acute exacerbation of COPD, the Average Volume-Assured Pressure Support (AVAPS) mode showed significant improvements in blood pH and pCO2 levels compared to BiPAP spontaneous/timed (S/T) mode at both 6 and 24 hours after treatment.

Patients treated with AVAPS also had a shorter average hospital stay, indicating that this mode may provide more effective management for acute exacerbations of COPD, although both modes did not differ significantly in the need for invasive mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Average Volume Assured Pressure Support Mode (AVAPS) in the Management of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Type 2 Respiratory Failure. Maheshwari, A., Khatri, J., Soni, G., et al.[2023]

In a study of 10 patients with obesity hypoventilation syndrome, bilevel pressure ventilation with spontaneous/timed (BPV-S/T) significantly improved oxygenation, sleep quality, and health-related quality of life (HRQL).

The addition of average volume-assured pressure support (AVAPS) further decreased carbon dioxide levels (PtcCO2) more effectively than BPV-S/T alone, but did not lead to additional improvements in sleep quality or HRQL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Average volume-assured pressure support in obesity hypoventilation: A randomized crossover trial. Storre, JH., Seuthe, B., Fiechter, R., et al.[2023]

In a study of 22 patients with COPD and hypercapnic encephalopathy, the use of BiPAP S/T with AVAPS significantly improved consciousness levels (measured by Glasgow Coma Scale) and reduced carbon dioxide levels compared to standard BiPAP S/T.

While BiPAP S/T with AVAPS showed better immediate clinical outcomes, there were no significant differences in the length of hospital stay or duration of non-invasive ventilation between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy. Briones Claudett, KH., Briones Claudett, M., Chung Sang Wong, M., et al.[2022]

In a study involving 60 critically ill patients with acute hypercarbic respiratory failure, the Average Volume-Assured Pressure Support (AVAPS) mode was found to be as effective as the Bilevel Positive Airway Pressure-Spontaneous/Timed (BPAP-S/T) mode for noninvasive mechanical ventilation, with no significant differences in treatment success rates or patient outcomes.

Both AVAPS and BPAP-S/T modes showed similar results in terms of pH, carbon dioxide levels, and overall mortality rates, indicating that AVAPS can be a viable alternative for managing respiratory failure in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of critically ill patients with acute hypercarbic respiratory failure by average volume-assured pressure support mode. Akbaş, T., Altun, G.[2021]

In a study of 58 patients with mild-to-moderate hypoxemic respiratory failure, the BiPAP·S/T-AVAPS mode did not show superior effectiveness compared to the conventional BiPAP·S/T mode in terms of success rates for noninvasive mechanical ventilation (NIMV).

Both ventilatory strategies had similar rates of intubation and mortality, with a high mortality rate of 22.4% observed among patients who experienced NIMV failure, highlighting the serious risks associated with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Mechanical Ventilation with Average Volume-Assured Pressure Support versus BiPAP S/T in De Novo Hypoxemic Respiratory Failure. Briones-Claudett, KH., Briones-Claudett, MH., Baños, MDPC., et al.[2022]

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK560600/

Average Volume-Assured Pressure Support - StatPearls - NCBI

AVAPS has been successful in the treatment of COPD-associated acute hypercapnic respiratory failure. Significant improvement was seen in arterial blood gases, ...

2.

journal.chestnet.org

journal.chestnet.org/article/S0012-3692(23)04271-X/fulltext

COMPARING AVERAGE VOLUME-ASSURED PRESSURE ...

These findings suggest that AVAPS is more efficient than BiPAP in reducing PaCO2 in the setting of acute hypercapnic respiratory failure.

3.

pulmonarychronicles.com

pulmonarychronicles.com/index.php/pulmonarychronicles/article/view/1383

Average volume-assured pressure support versus fixed ...

Objective: This review and meta-analysis analyze the outcomes with fixed pressure NIV versus average volume-assured pressure support NIV in ...

4.

respiratory-research.biomedcentral.com

respiratory-research.biomedcentral.com/articles/10.1186/s12931-020-1320-7

Effect of average volume-assured pressure support treatment ...

In COPD patients with hypercapnic respiratory failure, AVAPS improved exercise tolerance and multiple domains of HRQOL over six months of follow-up.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S088394411630332X

Evaluation of the feasibility of average volume-assured ...

Noninvasive ventilation was successful in 81 (76.4%) patients. The successful treatment group had a significantly higher baseline Glasgow Coma Score, pH, and ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06047405?term=ERYMAX&rank=4

NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T ...

The goal of this study is to compare two different modes of noninvasive ventilation in hypercapnic respiratory failure. The investigators will compare AVAPS ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34462252/

Comparison of BPAP S/T and Average Volume-Assured ...

Conclusion: The AVAPS mode is as effective and safe as BPAP S/T in treating patients with hypercapnic respiratory failure in the emergency department.