What is the mechanism of action of this treatment?

Common treatments for Acute Respiratory Distress Syndrome (ARDS) aim to improve oxygenation and reduce lung injury. Mechanical ventilation strategies like low tidal volume ventilation (LTVV) minimize ventilator-induced lung injury, while prone positioning enhances oxygenation by improving ventilation-perfusion matching. Conservative fluid management reduces pulmonary edema. The Continuous Negative Abdominal Pressure (CNAP) device, which reduces intra-abdominal pressure to improve respiratory mechanics and oxygenation, is particularly relevant for ARDS patients as it can enhance lung function and oxygen delivery while minimizing further lung injury.

What side effects are associated with this type of intervention?

Common treatments for ARDS include inhaled nitric oxide (NO), neuromuscular blocking agents (NMBs), and mechanical ventilation strategies. Inhaled NO can improve oxygenation but may cause renal impairment and does not reduce mortality. NMBs can enhance oxygenation but carry the risk of prolonged neuromuscular weakness. Mechanical ventilation, while essential, can lead to ventilator-induced lung injury. Continuous Negative Abdominal Pressure, a newer approach, aims to reduce intra-abdominal pressure to improve respiratory mechanics and oxygenation, potentially minimizing lung injury compared to traditional methods.

What prior FDA approvals exist?

Currently, the only FDA-approved treatment strategy for Acute Respiratory Distress Syndrome (ARDS) that has demonstrated a significant reduction in mortality is low tidal volume ventilation, a lung-protective ventilation strategy. Other therapies, including various pharmacologic agents and mechanical ventilation adjuncts, have not shown definitive benefits in large clinical trials. There are no FDA-approved treatments specifically similar to the Continuous Negative Abdominal Pressure (CNAP) device, which aims to reduce intra-abdominal pressure to improve respiratory mechanics and oxygenation.

What other types of research exist?

Promising alternatives to Continuous Negative Abdominal Pressure devices for ARDS patients include: 1) Positive End-Expiratory Pressure (PEEP) therapy, which helps maintain end-expiratory lung volume and improve oxygenation, especially when matched to intra-abdominal pressure. 2) High-Frequency Chest Wall Oscillation (HFCWO), which aids in airway clearance and can improve respiratory mechanics. 3) Noninvasive Positive Pressure Ventilation (NPPV), which supports breathing and can reduce the need for intubation. These methods have shown potential in improving respiratory outcomes in ARDS patients.

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CNAP for ARDS (CNAP in ARDS Trial)

N/A

Recruiting

Led By Laurent Brochard, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

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

Must have

Patients with moderate to severe ARDS as per the Berlin definition (PaO2/FiO2 ≤200mmHg)

Patients with absence of any significant cardiopulmonary disease

Must not have

Contraindication to CNAP

Severe liver insufficiency (Child-Pugh score > 7) or fulminant hepatic failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 min

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a device that uses gentle abdominal suction to help patients with severe lung issues breathe better. It aims to improve oxygen levels by making it easier for the lower parts of the lungs to expand.

Who is the study for?

This trial is for adults over 18 with moderate to severe ARDS, defined by specific oxygenation criteria. They shouldn't have significant heart or lung diseases apart from ARDS. People can't join if they have conditions that prevent the use of CNAP or EIT electrodes, severe liver issues, extreme respiratory acidosis, very high carbon dioxide levels in their blood, or advanced COPD.

What is being tested?

The trial is testing a device that applies continuous negative pressure to the abdomen in patients suffering from ARDS. The goal is to see if this device helps improve breathing and oxygen levels in these critically ill patients.

What are the potential side effects?

Potential side effects may include discomfort due to the negative pressure application, skin irritation where electrodes are placed for monitoring, and possible worsening of underlying conditions due to changes in abdominal pressure.

Eligibility Criteria

Inclusion Criteria

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

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My lung condition is severe, fitting the Berlin definition.

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I do not have any major heart or lung diseases.

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I am 18 years old or older.

Exclusion Criteria

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

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I cannot have CNAP due to health reasons.

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My liver is not working well (Child-Pugh score > 7).

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I have severe or very severe COPD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 min

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 min

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 min for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hypotension (SAFETY)

Oxygen saturation measurement

Oxygenation (SAFETY)

Secondary study objectives

Oxygenation (EFFICACY)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single armExperimental Treatment1 Intervention

Patients with ARDS will be placed inside of a Continuous Negative Abdominal Pressure Device. Negative pressure will be applied to the abdomen as an adjunct to positive pressure ventilation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CNAP

2011

N/A

~50

0 / 6Eligibility 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

Common treatments for Acute Respiratory Distress Syndrome (ARDS) aim to improve oxygenation and reduce lung injury. Mechanical ventilation strategies like low tidal volume ventilation (LTVV) minimize ventilator-induced lung injury, while prone positioning enhances oxygenation by improving ventilation-perfusion matching. Conservative fluid management reduces pulmonary edema. The Continuous Negative Abdominal Pressure (CNAP) device, which reduces intra-abdominal pressure to improve respiratory mechanics and oxygenation, is particularly relevant for ARDS patients as it can enhance lung function and oxygen delivery while minimizing further lung injury.

The pulmonary physician and critical care. 2. The injured lung: conventional and novel respiratory therapy.Adult respiratory distress syndrome: diagnosis and management.Negative-pressure-assisted ventilation lowers driving pressure and mechanical power in an ARDS model.