Noninvasive Ventilation Modes for Hypercapnic Respiratory Failure

Recruiting in Palo Alto (17 mi)

Overseen by Margarita Oks, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwell Health

Disqualifiers: Pregnancy, Hypotension, Chronic tracheostomy, others

No Placebo Group

Trial Summary

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.

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.

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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.

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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.

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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 am 18 years old or older.

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.

Trial 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

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Lenox Hill Hospital New York, NY

Who Is Running the Clinical Trial?

Northwell Health Lead Sponsor

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] Non-invasive mechanical ventilation (NIV) in patients with acute respiratory failure has been traditionally determined based on clinical assessment and changes in blood gases, with NIV support pressures manually adjusted by an operator. Bilevel positive airway pressure-spontaneous/timed (BiPAP S/T) with average volume assured pressure support (AVAPS) uses a fixed tidal volume that automatically adjusts to a patient's needs. Our study assessed the use of BiPAP S/T with AVAPS in patients with chronic obstructive pulmonary disease (COPD) and hypercapnic encephalopathy as compared to BiPAP S/T alone, upon immediate arrival in the Emergency-ICU.

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

Average volume-assured pressure support in obesity hypoventilation: A randomized crossover trial. [2023] Average volume-assured pressure support (AVAPS) has been introduced as a new additional mode for a bilevel pressure ventilation (BPV) device (BiPAP; Respironics; Murrysville, PA), but studies on the physiologic and clinical effects have not yet been performed. There is a particular need to better define the most efficient ventilatory treatment modality for patients with obesity hypoventilation syndrome (OHS).

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] Bilevel positive airway pressure in spontaneous/time and average volume-assured pressure support (BiPAP·S/T-AVAPS) could maintain an adequate tidal volume by reducing the patient's inspiratory effort; however, this ventilatory strategy has not been compared with other ventilatory modes, especially the conventional BiPAP S/T mode, when noninvasive mechanical ventilation (NIMV) is used. The primary objective of this study was to determine the rate of success and failure of the use of BiPAP·S/T-AVAPS versus BiPAP·S/T alone in patients with mild-to-moderate "de novo" hypoxemic respiratory failure.

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] Average volume-assured pressure support (AVAPS), a dual mode, delivers a set tidal volume (TV) per kg by adjusting the pressure between upper and lower inspiratory positive airway pressures (IPAP). Thus, ventilation is presumed to be happened effectively by sending a guaranteed TV. This study was aimed to evaluate the effectiveness of AVAPS mode in critically ill patients with acute hypercarbic respiratory failure (HRF) and compare the results with bilevel positive airway pressure-spontaneous/timed (BPAP-S/T) mode.

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] Background Non-invasive ventilation (NIV) is a well-established approach in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) with type 2 respiratory failure. Average volume-assured pressure support (AVAPS) mode integrates the characteristics of both volume and pressure-controlled modes of NIV. In bilevel positive airway pressure (BiPAP) mode, volume is the dependent variable, whereas in AVAPS mode, pressure is the dependent variable. In this study, we aimed to compare the role of AVAPS mode with BiPAP spontaneous/timed (S/T) mode for the management of patients with acute exacerbation of COPD with type 2 respiratory failure. Methodology A hospital-based comparative and analytical study was carried out on 100 patients with acute exacerbation of COPD with type 2 respiratory failure admitted to respiratory disease hospital, Sardar Patel Medical College, Bikaner (Rajasthan, India). Patients were randomly divided into two groups of 50 patients each. Group A patients were treated with AVAPS mode and group B patients with BiPAP (S/T) mode. Arterial blood gases, average duration of hospital stay, and need for invasive mechanical ventilation were compared between the two groups. Results There was a statistically significant difference in favor of group A in terms of improvement in pH and pCO2 as compared to group B at 6 h (pH, p=0.027; pCO2, p=0.012) and 24 h (pH, p=0.032; pCO2, p=0.013). The duration of hospital stay was found to be lower in group A (p=0.003). However, no significant difference was found in terms of need for invasive mechanical ventilation between both groups (p=0.338). Conclusion Application of AVAPS mode results in more rapid and steady improvement in patients of COPD as compared to BiPAP (S/T) mode. Thus, management through non-invasive ventilation AVAPS mode should be considered in patients with acute exacerbation of COPD with type 2 respiratory failure.