Mechanical Unloading for Obesity in Aging

Overseen By Abide Abulimiti, Ph.D.

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Exercise capacity drugs

Disqualifiers: Smoking, Heart disease, Hypertension, Asthma, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how obesity affects lung function and exercise tolerance in older adults and tests whether a device called "Mechanical Unloading of the Thorax" can help. The device eases chest pressure and might improve breathing and exercise ability in obese older adults, especially those experiencing breathlessness. The trial seeks healthy individuals aged 65 to 75 with some excess body fat, who do not smoke, have no serious health conditions, and can perform exercise tests. As an unphased trial, this study offers a unique opportunity to contribute to understanding how innovative devices can enhance the quality of life for older adults.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not take any current medications that may interfere with exercise capacity. If you are on such medications, you may need to stop them to participate.

What prior data suggests that this mechanical unloading technique is safe for older adults?

Research has shown that biphasic cuirass ventilation, a method that aids breathing without a tube down the throat, is generally well-tolerated. This technique uses gentle pressure to assist breathing and is applied in various situations, such as during certain surgeries and in critical care.

Reports indicate that this method can be used safely for extended periods. Although, like any treatment, it may have some side effects, they are usually not severe. Most patients adapt to the treatment without major issues.

This trial focuses on older adults, who may experience different side effects than younger individuals. While this trial does not yet specify its findings, other studies suggest that this method is generally safe. It is important to consult healthcare providers to determine if this treatment is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike typical obesity treatments that often involve medication or lifestyle changes like diet and exercise, mechanical unloading of the thorax offers a completely different approach. This technique uses an external cuirass to apply gentle pressure, effectively reducing the workload on the chest and potentially influencing metabolism. Researchers are excited because this non-invasive method could provide a new way to manage obesity, especially in older adults, without the need for drugs or surgery. This innovative approach could offer a safer and more accessible option for those who may not respond well to traditional treatments.

What evidence suggests that mechanical unloading of the thorax is effective for improving respiratory function and exercise tolerance in older obese adults?

Research has shown that biphasic cuirass ventilation, experienced by participants in this trial as mechanical unloading of the thorax, can improve breathing by gently pulling on the chest. This technique can strengthen breathing muscles and increase blood oxygen levels. In one case, a patient with severe obesity experienced significantly improved breathing after using this method. It has also supported the lungs without surgery. These findings suggest that this method could help older adults with obesity breathe better and become more active. ^{2 3 4 5 6}

Who Is on the Research Team?

Tony G Babb, Ph.D.

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for healthy older adults aged 65-75 with normal lung function and specific body fat percentages (men: 30-50%, women: 35-55%). Participants should be nonsmokers, without significant mental illness, uncontrolled hypertension, serious health conditions affecting exercise capacity, metabolic disorders like diabetes, or a history of substance abuse. Only postmenopausal women are eligible.

Inclusion Criteria

Nonsmokers with no history of smoking

I can exercise without being limited by a physical condition.

I am a postmenopausal woman.

Exclusion Criteria

Individuals participating in regular vigorous conditioning exercise more than two times per week

Subjects with an exceedingly high exercise capacity (greater than 2 SD of predicted)

I am a woman who has not gone through menopause.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of lung function, exercise tolerance, and DOE using various measurements and questionnaires

1 week

1 visit (in-person)

Intervention

Participants undergo mechanical unloading of the thorax using continuous negative cuirass pressure and assisted biphasic cuirass ventilation

6 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in respiratory function, exercise tolerance, and DOE after intervention

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mechanical unloading of the Thorax

Trial Overview The study tests if mechanical unloading of the thorax using an external cuirass can improve lung function and exercise tolerance in obese older adults. It compares respiratory functions and breathlessness during rest and exercise between those with obesity-related respiratory symptoms and those without.

How Is the Trial Designed?

Group I: Interventional Arm Experimental Treatment 1 Intervention

Older group of adults (65-75 yrs). Everyone enrolled uses the 'intervention'/ external cuirass - mechanical unloading of thorax

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study involving five piglets and five adult rabbits with lung injuries, respiratory mechanical unloading significantly reduced chest wall distortion (CWD), improving breathing mechanics and efficiency.

The technique led to increased tidal volume and decreased partial pressure of arterial CO2, suggesting enhanced ventilatory efficiency without affecting the respiratory rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of respiratory mechanical unloading on thoracoabdominal motion in meconium-injured piglets and rabbits. Schulze, A., Suguihara, C., Gerhardt, T., et al.[2019]

In a study involving 12 patients with class III obesity and 6 control participants, using CPAP (Continuous Positive Airway Pressure) matched to pleural pressure significantly decreased the work of breathing and improved respiratory mechanics without affecting heart function.

The CPAP treatment also led to better oxygen saturation and more even distribution of tidal volume in the lungs, indicating it can be a safe and effective intervention for improving breathing in patients with severe obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pleural Pressure Targeted Positive Airway Pressure Improves Cardiopulmonary Function in Spontaneously Breathing Patients With Obesity. Florio, G., De Santis Santiago, RR., Fumagalli, J., et al.[2022]

Morbid obesity significantly impairs respiratory function, leading to increased risks of both acute hypoxaemic and hypercapnic respiratory failure, making early diagnosis and management crucial.

Non-invasive ventilation has been shown to improve respiratory outcomes and survival in morbidly obese patients with hypoventilation, reducing the need for invasive mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing acute respiratory decompensation in the morbidly obese. Bahammam, AS., Al-Jawder, SE.[2022]

The study on eight anesthetized cats demonstrated that elastic unloading (negative ventilator compliance) can effectively adjust the total compliance of the lung-respirator system, with measured values closely aligning with theoretical predictions.

Elastic unloading improved tidal volume and reduced arterial PCO2 in healthy lungs, suggesting its potential benefits in mechanical ventilation, especially during the weaning process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assisted mechanical ventilation using elastic unloading: a study in cats with normal and injured lungs. Schulze, A., Schaller, P., Jonzon, A., et al.[2008]

In a study of 15 postoperative morbidly obese patients on mechanical ventilation, tidal expiratory flow limitation (EFL) was found in 10 patients, indicating that EFL is common in this population when no positive end-expiratory pressure (PEEP) is applied.

Applying an average PEEP of 7.5 cm H2O effectively abolished EFL and improved respiratory mechanics, although it did not significantly enhance gas exchange, which was likely impaired due to atelectasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory flow limitation in morbidly obese postoperative mechanically ventilated patients. Koutsoukou, A., Koulouris, N., Bekos, B., et al.[2013]

In a study of 14 critically ill morbidly obese patients, using recruitment maneuvers followed by titration of positive end-expiratory pressure (PEEP) significantly improved lung volumes and oxygenation, indicating a more effective mechanical ventilation strategy.

The standard PEEP levels set by clinicians were found to be inadequate, leading to lower lung volumes and worse oxygenation, highlighting the need for tailored PEEP adjustments in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment Maneuvers and Positive End-Expiratory Pressure Titration in Morbidly Obese ICU Patients. Pirrone, M., Fisher, D., Chipman, D., et al.[2022]

Recruitment maneuvers followed by positive end-expiratory pressure (PEEP) are effective in improving ventilation for obese patients undergoing bariatric surgery, as shown in a systematic review of 13 randomized controlled trials.

Noninvasive positive pressure ventilation (NIPPV) during induction is beneficial for preventing atelectasis and extending safe apnea duration, highlighting its importance in managing ventilation challenges in obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Ventilation Strategies for Obese Patients Undergoing Bariatric Surgery: A Literature Review. Hu, XY.[2022]

In mechanically ventilated patients, the risk of ventilator-induced lung injury is influenced by both lung and chest wall mechanics, particularly in those with morbid obesity and severe hypoxemia, as shown by a study involving 213 subjects across four groups.

The study found that driving pressure and dynamic power were significantly higher in patients with morbid obesity and severe hypoxemia, indicating that ventilator settings should be adjusted to account for these factors to minimize lung injury risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elastic Power of Mechanical Ventilation in Morbid Obesity and Severe Hypoxemia. Syed, MKH., Selickman, J., Evans, MD., et al.[2023]

In critically ill obese patients on mechanical ventilation, adopting a sitting position significantly improved respiratory mechanics by relieving expiratory flow limitation and reducing auto-positive end-expiratory pressure, leading to lower alveolar pressures.

Applying positive end-expiratory pressure further enhanced these benefits, effectively reversing expiratory flow limitation without increasing plateau pressure, making it a beneficial strategy for managing respiratory function in severely obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sitting position and applied positive end-expiratory pressure on respiratory mechanics of critically ill obese patients receiving mechanical ventilation*. Lemyze, M., Mallat, J., Duhamel, A., et al.[2022]

Obesity leads to specific challenges in mechanical ventilation due to decreased lung volume and increased airway inflammation, which can impair gas exchange and respiratory mechanics.

To minimize lung injury and manage ventilation effectively in obese patients, strategies such as stepwise recruitment maneuvers and careful tidal volume titration are essential to reduce lung stress and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical ventilation in obese patients. Leme Silva, P., Pelosi, P., Rocco, PR.[2022]

Citations

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

Efficacy of biphasic cuirass ventilation in the critical care ... Biphasic cuirass ventilation (BCV) assists ventilation by applying intermittent or continuous negative pressure to the thorax.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11063806/

A Case Report - PMC In this case, we report a significant improvement in the respiratory condition of a patient with severe obesity and inhalation burns following ...

3. atsjournals.org atsjournals.org/doi/pdf/10.1164/ajrccm.163.2.9906116

Noninvasive Ventilation Noninvasive ventilation refers to the delivery of mechanical ventilation to the lungs using techniques that do not require an endotracheal airway. During the ...

4. researchgate.net researchgate.net/publication/10887355_Long-term_negative_pressure_ventilation

Long-term negative pressure ventilation | Request PDF Many studies, although uncontrolled, have shown that long-term treatment with NPV can improve respiratory muscle function, arterial blood gases, ...

5. cureus.com cureus.com/articles/324274-biphasic-cuirass-ventilation-for-airway-surgeries-a-comprehensive-review

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

6. withpower.com withpower.com/clinical-trials/for-aging

Top Aging Clinical Trials | Power Aim 4) Mechanical unloading of the thorax will improve respiratory function, submaximal exercise tolerance, and DOE in older obese adults, but to a greater ...