Negative Pressure Ventilation for Acute Hypercapnic Respiratory Failure

Overseen By Armin Krvavac, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Age <21, Pregnant, Inmate, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1-3 days

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with acute hypercapnic respiratory failure, a condition where the lungs cannot remove enough carbon dioxide. Researchers aim to determine if a device called Biphasic Cuirass Ventilation is as effective as the usual method, Non-Invasive Positive Pressure Ventilation, which aids breathing without requiring a tube down the throat. Suitable candidates for this trial include those recently diagnosed with this breathing issue and who have specific blood pH levels. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that Biphasic Cuirass Ventilation is safe for patients with acute hypercapnic respiratory failure?

Research shows that Biphasic Cuirass Ventilation (BCV) is generally safe for patients. Studies have found that BCV can help patients breathe effectively without causing major harm. For instance, it has been used successfully during airway surgeries to assist breathing without traditional breathing tubes. One study found that BCV helped 69% of children with severe breathing problems, with complications in less than 2% of cases. This suggests that BCV is well-tolerated and has few serious side effects.

While these studies support BCV's safety, individual experiences may vary. Patients should consult their doctor to determine if this treatment is suitable for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Negative Pressure Ventilation for acute hypercapnic respiratory failure is unique because it uses Biphasic Cuirass Ventilation, a method that mimics natural breathing by creating negative pressure around the chest. Unlike the standard of care, which typically involves non-invasive positive pressure ventilation (NIPPV) to push air into the lungs, this technique gently draws air in, potentially offering a more comfortable and less intrusive experience for patients. Researchers are excited about this method because it could improve patient outcomes by enhancing ventilation efficiency and reducing the work of breathing, which might lead to quicker recovery times and better overall respiratory function.

What evidence suggests that Biphasic Cuirass Ventilation is effective for acute hypercapnic respiratory failure?

Research has shown that Biphasic Cuirass Ventilation (BCV), which participants in the intervention arm of this trial will receive, can improve lung function in various breathing problems. This method mimics natural breathing, offering more comfort for patients. Studies have found that BCV can be used successfully during surgeries to manage breathing without a breathing tube. It can also quickly assist patients experiencing severe breathing difficulties. These findings suggest that BCV could be a promising option for patients with acute hypercapnic respiratory failure, a condition characterized by excessive carbon dioxide in the blood. ^{3 4 6 7 8}

Who Is on the Research Team?

Dennis Chairman, MD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This trial is for adults over 21 hospitalized with acute hypercapnic respiratory failure, which means they have too much carbon dioxide in their blood. They must not be pregnant, prisoners, or have a BMI over 50. Also excluded are those with chest injuries/surgeries, chest wall defects, or muscle/nerve issues affecting breathing.

Inclusion Criteria

Your blood pH is not within the normal range.

I was admitted for high carbon dioxide levels in my blood.

Exclusion Criteria

I cannot use a cuirass ventilator due to chest conditions or past surgery.

Pregnant

Inmate/Prisoner

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

Treatment

Patients are randomized to receive either Biphasic Cuirass Ventilation or Non-invasive Positive Pressure Ventilation

1-3 days

Continuous monitoring in Medical ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Intervention Arm

Trial Overview The study is testing the effectiveness of Biphasic Cuirass Ventilation (BCV) compared to Non-invasive Positive Pressure Ventilation (NPPV) in managing patients with acute hypercapnic respiratory failure to see if BCV can help them breathe easier and manage carbon dioxide levels.

How Is the Trial Designed?

Group I: Intervention Arm Active Control 1 Intervention

Patient in this arm will be placed on Biphasic Cuirass Ventilation

Group II: Conventional Arm Active Control 1 Intervention

Patients will be placed on Non invasive positive pressure ventilation per current standard of care.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Hayek Medical

Collaborator

Trials

2

Recruited

70+

Published Research Related to This Trial

Nasal high-flow (NHF) therapy effectively reduces carbon dioxide levels (paCO2) in patients with hypercapnic interstitial lung disease (ILD), likely by washing out the respiratory tract and decreasing functional dead space.

In a study involving 25 hypercapnic ILD patients, NHF improved breathing comfort and reduced respiratory rates, demonstrating its potential as a beneficial ventilatory support option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal High-Flow (NHF) Improves Ventilation in Patients with Interstitial Lung Disease (ILD)-A Physiological Study. Bräunlich, J., Köhler, M., Wirtz, H.[2023]

In a study of 201 COPD patients with prolonged hypercapnia after acute respiratory failure, nocturnal non-invasive positive pressure ventilation (NIV) did not significantly reduce the time to readmission for respiratory issues or death compared to standard treatment over 12 months.

However, NIV did lead to significant improvements in daytime and nighttime carbon dioxide levels (PaCO2), suggesting it may still have beneficial effects on respiratory function, and there was a trend towards improved health-related quality of life that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nocturnal non-invasive ventilation in COPD patients with prolonged hypercapnia after ventilatory support for acute respiratory failure: a randomised, controlled, parallel-group study. Struik, FM., Sprooten, RT., Kerstjens, HA., et al.[2022]

A retrospective study comparing two cohorts of COPD patients with acute hypercapnic respiratory failure showed that those treated with higher inspiratory positive airway pressure (IPAP) of 20 cm H2O had significantly lower in-hospital mortality (13.8%) compared to those treated with lower IPAP (40.5%).

The study found that patients in the higher IPAP group also had better short-term and long-term survival rates, with a 1-year survival analysis indicating a 55% reduction in the risk of death compared to the lower IPAP group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-pressure NIV for acute hypercapnic respiratory failure in COPD: improved survival in a retrospective cohort study. Hedsund, C., Nilsson, PM., Hoyer, N., et al.[2022]

Intermittent negative pressure ventilation (INPV) combined with increasing oxygen concentrations was tested on 17 male patients with severe COPD, successfully raising arterial oxygen levels without worsening carbon dioxide retention.

This method not only improved oxygen levels significantly (from 47.2 mm Hg to 61.5 mm Hg) but also reduced carbon dioxide levels (from 74.4 mm Hg to 65.6 mm Hg), suggesting it could be a safer alternative to intubation and mechanical ventilation for patients with severe respiratory failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent short-term negative pressure ventilation and increased oxygenation in COPD patients with severe hypercapnic respiratory failure. Sauret, JM., Guitart, AC., Rodríguez-Froján, G., et al.[2019]

In a study of 34 patients with acute exacerbations of chronic obstructive pulmonary disease (COPD), those receiving higher oxygen therapy (targeting >9 kPa) had no poor outcomes, while the low-oxygen group experienced two cases of mechanical ventilation and one death, although this difference was not statistically significant.

The findings suggest that traditional guidelines for oxygen therapy in hypercapnic COPD patients may need reevaluation, as no severe complications like coma or cardiac arrhythmias occurred in either group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen therapy for hypercapnic patients with chronic obstructive pulmonary disease and acute respiratory failure: a randomized, controlled pilot study. Gomersall, CD., Joynt, GM., Freebairn, RC., et al.[2019]

In a study of 12 pediatric patients with acute moderate hypercapnic respiratory insufficiency, noninvasive positive pressure ventilation (NPPV) significantly improved breathing patterns and gas exchange, leading to increased tidal volume and minute ventilation by 33% and 17%, respectively.

NPPV also reduced the effort required by respiratory muscles, as indicated by a 49% decrease in oesophageal pressure and a 56% decrease in diaphragmatic pressure, resulting in a significant drop in carbon dioxide levels from 48 to 40 mmHg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological effects of noninvasive positive ventilation during acute moderate hypercapnic respiratory insufficiency in children. Essouri, S., Durand, P., Chevret, L., et al.[2021]

Respiratory muscle training (RMT) significantly improved inspiratory muscle strength in patients with restrictive thoracic disorders, with a 27.6% increase in maximal inspiratory mouth pressure after three months of training.

Patients who underwent RMT also showed enhanced exercise performance and health-related quality of life, evidenced by increased peak oxygen consumption and improved physical performance scores compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory muscle training in restrictive thoracic disease: a randomized controlled trial. Budweiser, S., Moertl, M., Jörres, RA., et al.[2006]

In a study involving 184 patients with severe COPD, negative pressure ventilation (NPV) did not show any significant improvement in walking distance or other secondary outcomes compared to a sham treatment over a 12-week period.

The intervention was poorly accepted by patients and did not demonstrate a dose-response relationship, leading to the conclusion that NPV is ineffective for resting respiratory muscles in stable COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of negative pressure ventilation in severe chronic obstructive pulmonary disease. Shapiro, SH., Ernst, P., Gray-Donald, K., et al.[2019]

In a study involving 17 patients with chronic hypercapnic respiratory failure, non-invasive ventilation (NIV) significantly increased endurance time during unsupported arm exercise by an average of 91 seconds and reduced feelings of breathlessness by 2.3 points on the Borg scale.

While NIV showed a trend towards increased walking endurance in 15 patients, it did not significantly improve exercise capacity during ground walking, suggesting that the pressure support may not have been sufficient to reduce dyspnoea in that activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive ventilation during arm exercise and ground walking in patients with chronic hypercapnic respiratory failure. Menadue, C., Alison, JA., Piper, AJ., et al.[2019]

In a study of 275 hospitalized patients with acute exacerbation of COPD, 37.8% developed hypercapnia, with severe airflow limitation (low FEV1) identified as the primary risk factor for this condition.

The study established critical FEV1 cut-off points (42.12% and 0.8 L) that can help predict hypercapnia, suggesting that patients with severe airflow limitation should be closely monitored to prevent complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypercapnic Failure in Acute Exacerbated COPD Patients: Severe Airflow Limitation as an Early Warning Signal. Grünewaldt, A., Fritsch, N., Rohde, G.[2023]

In a study of 29 patients with chronic obstructive pulmonary disease (COPD), those who underwent inspiratory muscle training (IMT) showed a significant improvement in walking distance from 94 meters to 290 meters over 4 weeks, compared to a sham group that improved from 93 meters to 196 meters.

IMT also led to a notable increase in inspiratory muscle strength, with maximal inspiratory pressure rising from -35 to -55 cmH2O, while the sham group did not show significant changes, highlighting the efficacy of IMT in enhancing respiratory function in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training during rehabilitation in successfully weaned hypercapnic patients with COPD. Dellweg, D., Reissig, K., Hoehn, E., et al.[2022]

Non-invasive ventilation is crucial for managing acute hypercapnic respiratory failure, significantly improving patient outcomes and reducing mortality rates, highlighting the importance of timely treatment initiation and proper patient selection.

Emerging therapies like nasal high flow may provide alternative options for patients who struggle with non-invasive ventilation, but further research is needed to fully assess their effectiveness in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute hypercapnic respiratory failure and its management on the acute medical take. Saigal, A., Shah, AJ., Mandal, S.[2021]

Early upper-limb exercise training combined with general physiotherapy significantly improves exercise capacity in patients recovering from acute respiratory failure after mechanical ventilation, as shown by better performance in both incremental and endurance tests.

The study indicates that early exercise training is feasible and beneficial in respiratory intermediate ICUs, with improvements in muscle fatigue and dyspnea, particularly in patients with better baseline inspiratory muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supported arm training in patients recently weaned from mechanical ventilation. Porta, R., Vitacca, M., Gilè, LS., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11717378/

Biphasic Cuirass Ventilation for Airway Surgeries Biphasic cuirass ventilation (BCV) has been used effectively to provide tubeless airway management in patients undergoing airway surgeries.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06108284/impact-of-negative-pressure-ventilation-in-patients-hospitalized-with-acute-hypercapnic-respiratory-failure

Impact of Negative Pressure Ventilation in Patients ... The study aims to find if using a Biphasic Cuirass Ventilation is as effective as using a Non invasive Positive Pressure Ventilation in patients ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1441277223015661

Cuirass Ventilation: A Review and Update Cuirass ventilation is a valid and valuable method of ventilation in a subset of patients as illustrated by the case reports in this review.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3363550/

Efficacy of biphasic cuirass ventilation in the critical care ... BCV has been reported to improve lung function in various respiratory failures. However, to determine the therapeutic effect of BCV is difficult, because it is ...

5. oxycare-gmbh.de oxycare-gmbh.de/assets/files/studien/BCV%20September%202019%20Cuirass%20Ventilation%20An%20Alternative%20Home-Based%20Modality%20for%20Chronic%20Respiratory%20Failure%201084822319875111.pdf

Cuirass Ventilation: An Alternative Home-Based Modality ... Biphasic cuirass ventilation can also be used to rapidly resuscitate patients in acute respiratory distress and requires minimal technical skill to operate ...

6. trialx.com trialx.com/clinical-trials/listings/283778/impact-of-negative-pressure-ventilation-in-patients-hospitalized-with-acute-hypercapnic-respiratory-failure/?&radius=50

Impact of Negative Pressure Ventilation in Patients ... The study aims to find if using a Biphasic Cuirass Ventilation is as effective as using a Non invasive Positive Pressure Ventilation in patients ...

7. withpower.com withpower.com/trial/phase-respiratory-insufficiency-9-2023-f1117

Negative Pressure Ventilation for Acute Hypercapnic ... In a study involving 25 hypercapnic ILD patients, NHF improved breathing comfort and reduced respiratory rates, demonstrating its potential as a beneficial ...

8. liebertpub.com liebertpub.com/doi/10.4187/respcare.07020

Predictors of Negative Pressure Ventilation Response in ... Negative pressure ventilation successfully supported 69% of pediatric subjects with all-cause acute respiratory failure with a complication rate < 2%. Oxygen ...