What side effects are associated with this type of intervention?

Common side effects of noninvasive ventilation treatments for hypercapnic respiratory failure, such as AVAPS and BIPAP S/T, include nasal congestion, dryness or irritation of the nasal passages, skin breakdown or discomfort from the mask, and gastric distension. Less common but more serious side effects can include barotrauma, aspiration, and pneumothorax.

What prior FDA approvals exist?

Noninvasive ventilation (NIV) methods, such as BIPAP (Bilevel Positive Airway Pressure) and AVAPS (Average Volume Assured Pressure Support), are commonly used to manage hypercapnic respiratory failure. These methods have been widely adopted in clinical practice and are generally approved by the FDA for treating conditions that cause respiratory failure, including chronic obstructive pulmonary disease (COPD) and other forms of respiratory distress. BIPAP provides two levels of pressure support for inhalation and exhalation, while AVAPS adjusts pressure support to maintain a target tidal volume, ensuring adequate ventilation. Both methods aim to improve gas exchange and reduce the work of breathing in patients with hypercapnic respiratory failure.

What other types of research exist?

Promising novel alternatives to AVAPS and BIPAP S/T for hypercapnic respiratory failure patients include High-Flow Nasal Cannula (HFNC) therapy, which provides heated and humidified oxygen at high flow rates, and Neurally Adjusted Ventilatory Assist (NAVA), which uses the patient's neural respiratory signals to deliver synchronized ventilatory support. Both methods have shown potential in improving patient comfort and outcomes.

← Back to Search

Device

Noninvasive Ventilation Modes for Hypercapnic Respiratory Failure

N/A

Recruiting

Led By Margarita Oks, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with hypercapnic respiratory failure on admission (ABG)

Requiring noninvasive ventilation as determined by the treating physician for the treatment of hypercarbic respiratory failure

Must not have

Patients at risk of aspirating gastric contents

Hypotension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from wearing the masks, skin irritation where the mask touches the face, dry mouth or nosebleeds due to airflow pressure, and possible stomach bloating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I need a machine to help me breathe due to high CO2 levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have low blood pressure.

Select...

I struggle to breathe or clear my throat properly.

Select...

I need frequent adjustments to my breathing support to keep my breaths consistent.

Select...

I am currently on a breathing machine.

Select...

I am under 18 years old.

Select...

I have an ear infection or sinus infection.

Select...

I have not been treated for whooping cough.

Select...

I need a machine to help me breathe at specific volumes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ICU length of stay of telemetry length of stay

Secondary study objectives

Days on NIV

Difference in PaCO2 value with NIV

Need for ICU stay

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Average Volume-Assured Pressure Support (AVAPS)Active Control1 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 Control1 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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Hypercapnic Respiratory Failure, such as AVAPS and BiPAP S/T, work by enhancing ventilation and improving gas exchange. AVAPS adjusts pressure support to maintain a target tidal volume, ensuring consistent ventilation and preventing CO2 retention. BiPAP S/T provides two levels of pressure support: higher during inhalation to assist breathing in and lower during exhalation to facilitate easier breathing out. These mechanisms reduce the work of breathing and help manage hypercapnia by maintaining adequate alveolar ventilation and reducing CO2 levels, which is crucial for improving respiratory function in hypercapnic patients.

Noninvasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy.Continuous positive airway pressure versus bilevel noninvasive ventilation in acute cardiogenic pulmonary edema: a randomized multicenter trial.Noninvasive ventilation: experience at a community teaching hospital.