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

Trial Summary

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 data supports the effectiveness of the treatment Average Volume-Assured Pressure Support (AVAPS) for hypercapnic respiratory failure?

Research shows that AVAPS can lead to more rapid and steady improvement in patients with chronic obstructive pulmonary disease (COPD) and type 2 respiratory failure compared to BiPAP S/T mode, with better pH and carbon dioxide levels and shorter hospital stays. ^{1 2 3 4 5}

Is noninvasive ventilation with AVAPS safe for humans?

Research on noninvasive ventilation modes like AVAPS and BiPAP S/T shows they are generally safe for treating conditions like chronic obstructive pulmonary disease and respiratory failure. These studies did not report significant safety concerns, indicating that these treatments are typically well-tolerated by patients. ^{1 2 3 4 5}

How does the treatment AVAPS differ from other treatments for hypercapnic respiratory failure?

AVAPS is unique because it automatically adjusts the pressure to deliver a fixed amount of air (tidal volume) based on the patient's needs, unlike traditional BiPAP S/T which requires manual adjustments. This can lead to more stable and rapid improvements in conditions like COPD with type 2 respiratory failure, potentially reducing hospital stay duration. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial compares two types of breathing support machines for adults with high carbon dioxide levels in their blood. These machines help patients breathe by pushing air into their lungs through a mask. The study aims to find out which machine helps patients recover faster. One type of machine automatically adjusts to a patient's needs and has been shown to help patients recover consciousness quickly.

Research Team

Margarita Oks, MD

Principal Investigator

Lenox Hill Hospital/Northwell Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

References

1. England 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. [2022]

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

Average volume-assured pressure support in obesity hypoventilation: A randomized crossover trial. [2023]

3. Egypt pubmed.ncbi.nlm.nih.gov

Noninvasive Mechanical Ventilation with Average Volume-Assured Pressure Support versus BiPAP S/T in De Novo Hypoxemic Respiratory Failure. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2023]