CNEP + HFNC for Respiratory Insufficiency

Overseen by Jeremy Beitler, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Columbia University

Disqualifiers: Pregnancy, Asthma, COPD, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is being conducted to evaluate if wearing a non-invasive breathing support device over the chest/abdomen improves markers of breathing in patients with lung injury requiring high-flow oxygen. The breathing support device consists of a plastic shell that sits over the chest and abdomen and connects to a vacuum that helps the chest expand with breathing. This breathing support is known as continuous negative external pressure (CNEP). Study findings will help determine if this breathing support device might be useful for patients with acute hypoxemic respiratory failure (AHRF).

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment CNEP + HFNC for Respiratory Insufficiency?

Research shows that high-flow nasal cannula (HFNC) is an effective alternative to other non-invasive respiratory supports like nasal continuous positive airway pressure (nCPAP) after extubation in preterm infants, suggesting its potential benefit in managing respiratory insufficiency. ^{1 2 3 4 5}

How is the CNEP + HFNC treatment for respiratory insufficiency different from other treatments?

The CNEP + HFNC treatment is unique because it combines continuous negative external pressure (CNEP), which helps the lungs expand by creating a vacuum around the chest, with high-flow nasal cannula (HFNC) therapy, which delivers oxygen at a high flow rate through the nose. This combination offers a non-invasive way to support breathing, potentially providing an alternative to more invasive methods like mechanical ventilation. ^{2 4 6 7 8}

Research Team

Jeremy Beitler, MD, MPH

Principal Investigator

Columbia University

Eligibility Criteria

Adults with non-heart-related lung injury needing high-flow oxygen can join this trial. They must have started using a high-flow nasal cannula within the last four days and maintain certain oxygen levels. People with unreliable pulse-oximetry, chest injuries, severe blood pressure issues, do-not-intubate orders, or conditions affecting device fit like severe spine curvature cannot participate.

Inclusion Criteria

I am experiencing severe difficulty breathing due to low oxygen levels.

Your oxygen levels are at least 92%.

I need a high level of oxygen support.

Exclusion Criteria

My doctor has advised against me joining the trial.

You have a medical order that says not to use a breathing tube.

Your Glasgow coma score is less than 15.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Measurement

Perform baseline measures and wait for recovery

15 minutes

1 visit (in-person)

Treatment

Participants undergo 4 strategies of respiratory support with random treatment assignments

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• CNEP10 (Device)
• CNEP20 (Device)
• CNEP30 (Device)
• HFNC + CNEP10 (Device)
• HFNC + CNEP20 (Device)
• HFNC + CNEP30 (Device)
• HFNC only (Device)

Trial Overview The study tests if a non-invasive breathing support device called CNEP improves breathing in patients with acute hypoxemic respiratory failure. Participants will receive different levels of negative pressure (CNEP30, CNEP20, CNEP10) along with standard high-flow nasal cannula therapy to see which works best.

Participant Groups

Group I: HFNC + CNEP30 Experimental Treatment 1 Intervention

Group II: HFNC + CNEP20 Experimental Treatment 1 Intervention

Group III: HFNC + CNEP10 Experimental Treatment 1 Intervention

Group IV: HFNC only Active Control 1 Intervention

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

In a study of very premature infants (≤28 weeks gestation and <1,250 g birth weight), using heated humidified high-flow nasal cannula (HHFNC) alongside nasal continuous positive airway pressure (NCPAP) significantly reduced the duration of NCPAP use by 50% compared to low-flow nasal cannula (LFNC).

HHFNC was associated with a lower incidence of nasal bridge lesions (0% vs. 13% in the NCPAP group) and improved cost-effectiveness by reducing overall treatment costs by 33%, while maintaining similar respiratory and non-respiratory outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heated humidified high-flow nasal cannula versus low-flow nasal cannula as weaning mode from nasal CPAP in infants ≤28 weeks of gestation. Fernandez-Alvarez, JR., Gandhi, RS., Amess, P., et al.[2021]

In a study involving 372 preterm infants, high-flow nasal cannula (HFNC) was associated with a significantly higher rate of treatment failure (31%) compared to nasal continuous positive airway pressure (NCPAP) or nasal intermittent positive-pressure ventilation (NIPPV) (16%) after extubation.

Factors such as histologic chorioamnionitis, treated patent ductus arteriosus, and younger corrected gestational age were identified as independent predictors of treatment failure when using HFNC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of High-Flow Nasal Cannula in Preterm Infants After Extubation. Uchiyama, A., Okazaki, K., Kondo, M., et al.[2021]

In a study of 120 patients with acute hypoxemic respiratory failure, high-flow nasal cannula (HFNC) treatment resulted in significantly lower rates of abdominal distension compared to noninvasive positive-pressure ventilation (NPPV), indicating a safer profile for HFNC.

Both HFNC and NPPV showed similar effectiveness in preventing respiratory failure post-extubation, with no significant differences in key respiratory parameters or re-intubation rates, suggesting that HFNC may be a preferable option due to its lower incidence of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of outcomes of high-flow nasal cannula and noninvasive positive-pressure ventilation in patients with hypoxemia and various APACHE II scores after extubation. Shang, X., Wang, Y.[2021]

Nasal continuous positive airway pressure (nCPAP) is the preferred method for providing noninvasive respiratory support to preterm infants with respiratory distress syndrome, as it is more effective than high-flow nasal cannula (HFNC) in this role.

HFNC serves as a suitable alternative to nCPAP after extubation, indicating its usefulness in managing respiratory support in neonatal intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal Continuous Positive Airway Pressure and High-Flow Nasal Cannula Today. Dani, C.[2021]

The in vitro study highlighted that a pressure-limiting valve is essential for the humidified high-flow nasal cannula (HFNC) system, especially at flows of 2 L/minute or higher, to maintain appropriate pressures without leaks.

In the in vivo study involving 15 newborns, while mean end-expiratory esophageal pressure (EEEP) levels were similar between nasal continuous positive airway pressure (NCPAP+6) and HFNC, a decrease in flow led to increased respiratory rates, indicating potential respiratory distress as flow diminished.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observational study of humidified high-flow nasal cannula compared with nasal continuous positive airway pressure. Lampland, AL., Plumm, B., Meyers, PA., et al.[2022]

High-flow nasal cannula (HFNC) oxygen therapy is a safe and effective non-invasive treatment for children with respiratory illnesses, as demonstrated in a study of 66 children in a level 2 pediatric ward in South Africa, with no serious adverse events reported.

HFNC significantly reduced the need for transfer to higher-level care (level 3) for invasive ventilation, with only 24.2% of HFNC patients requiring such transfer compared to 100% in the historical cohort before HFNC was available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the use of high-flow nasal cannula oxygen therapy in hospitalised children at a regional hospital in the Cape Town Metro, South Africa. Hoffman, E., Reichmuth, KL., Cooke, ML.[2019]

In a study of 30 extremely preterm infants (average gestational age of 27 weeks and birth weight of 930 g), high flow nasal cannula (HFNC) was associated with longer respiratory pauses compared to nasal continuous positive airway pressure (NCPAP), indicating potential differences in respiratory stability between the two methods.

HFNC also required higher levels of fraction of inspired oxygen (FiO2) than NCPAP, suggesting that while both are used for respiratory support, HFNC may necessitate more oxygen to maintain adequate saturation in these vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study. Kanbar, LJ., Shalish, W., Latremouille, S., et al.[2021]

High-flow nasal cannulae (HFNC) show promise as a non-invasive respiratory support option for preterm infants, potentially offering similar benefits to nasal continuous positive airway pressure (NCPAP) in improving respiratory parameters, especially at flow rates above 2 liters/min.

Despite the feasibility of HFNC, there is still uncertainty regarding its overall efficacy and safety in preterm infants, highlighting the need for larger randomized trials before it can be widely recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-flow nasal cannulae for respiratory support of preterm infants: a review of the evidence. Manley, BJ., Dold, SK., Davis, PG., et al.[2012]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Heated humidified high-flow nasal cannula versus low-flow nasal cannula as weaning mode from nasal CPAP in infants ≤28 weeks of gestation. [2021]

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

Randomized Controlled Trial of High-Flow Nasal Cannula in Preterm Infants After Extubation. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of outcomes of high-flow nasal cannula and noninvasive positive-pressure ventilation in patients with hypoxemia and various APACHE II scores after extubation. [2021]

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

Nasal Continuous Positive Airway Pressure and High-Flow Nasal Cannula Today. [2021]

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

Observational study of humidified high-flow nasal cannula compared with nasal continuous positive airway pressure. [2022]

6. South Africa pubmed.ncbi.nlm.nih.gov

A review of the use of high-flow nasal cannula oxygen therapy in hospitalised children at a regional hospital in the Cape Town Metro, South Africa. [2019]

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

Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

High-flow nasal cannulae for respiratory support of preterm infants: a review of the evidence. [2012]