Transpulmonary Pressure-Guided Ventilation Weaning for Obesity-Related Respiratory Issues

Overseen By Andrew Wilhelm, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Mississippi Medical Center

Disqualifiers: Pleural disease, Neuromuscular, Neurologic, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help obese patients on ventilators breathe better and be removed from the ventilator sooner. The study compares two ventilator settings: one uses a standard approach (standard positive end expiratory pressure), and the other adjusts based on a specific lung pressure measurement (transpulmonary pressure guided positive end expiratory pressure). The goal is to reduce ventilator time, thereby decreasing the risk of complications such as infections or weakness. Suitable participants are those who are severely obese (BMI of 35 or higher) and have been on a ventilator for less than 48 hours due to breathing issues.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance ventilator care for obese patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for patients with obesity-related respiratory issues?

Research shows that a specific method to guide breathing support safely aids obese patients. This method adjusts breathing machine settings to improve blood oxygen levels. It measures chest pressure in a minimally invasive and low-risk manner. This approach has succeeded in similar cases, making it a promising option for reducing the time patients need on breathing machines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transpulmonary pressure-guided ventilation weaning for obesity-related respiratory issues because it offers a more personalized approach to setting ventilator pressures. Unlike the standard method where positive end expiratory pressure (PEEP) is set to a general range of 5-8 cm H2O, this technique adjusts PEEP based on each patient's transpulmonary pressure to a range of 0-2 cm H2O. This tailored method could potentially enhance the effectiveness of ventilation and improve outcomes by ensuring that the pressure settings are better suited to the individual's respiratory mechanics.

What evidence suggests that transpulmonary pressure guided positive end expiratory pressure is effective for obesity-related respiratory issues?

Research shows that adjusting breathing machine settings using a specific method can improve outcomes for obese patients. In this trial, one group of participants will receive transpulmonary pressure-guided positive end expiratory pressure (PEEP). This technique uses transpulmonary pressure to guide PEEP adjustments, a ventilator setting that helps keep the lungs open. Studies have found that this approach can safely improve blood oxygen levels by balancing lung pressure, making breathing easier and more effective. Better oxygen levels can lead to less time on the ventilator, reducing the risk of complications like infections or muscle weakness. This method appears promising for assisting obese patients with breathing problems. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for obese patients (BMI ≥ 35.0 kg/m²) who have been on a ventilator for less than 48 hours due to respiratory failure. It's not suitable for those with esophageal or gastrointestinal issues, low platelet counts, neuromuscular diseases, difficult airways, life expectancy under 48 hours, prior chronic ventilation needs, severe neurological injuries or known pleural diseases.

Inclusion Criteria

I have been on a breathing machine for less than 2 days due to breathing failure.

My BMI is 35 or higher, classifying me as class II obese or higher.

Exclusion Criteria

I cannot have an esophageal balloon catheter due to certain health issues.

You have a disease that affects your muscles and nerves.

You have a known problem with your airway that makes it hard to breathe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Transpulmonary pressure guided positive end expiratory pressure (PEEP) titration for ventilation and spontaneous breathing trials (SBT) to shorten the time to liberation from mechanical ventilation

4 weeks

Daily assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including mortality, ICU and hospital length of stay, and re-intubation rates

30 days

What Are the Treatments Tested in This Trial?

Interventions

• standard positive end expiratory pressure
• transpulmonary pressure guided positive end expiratory pressure

Trial Overview The study tests if using transpulmonary pressure to guide ventilation weaning in obese patients can reduce time spent on mechanical ventilation and prevent complications like infections and weakness compared to standard methods.

How Is the Trial Designed?

Group I: Transpulmonary pressure guided positive end expiratory pressure Experimental Treatment 1 Intervention

Patients in this group will have the positive end expiratory pressure on the ventilator set to a transpulmonary pressure of 0-2 cm H2O during ventilation and spontaneous breathing trials.

Group II: Standard positive end expiratory pressure Active Control 1 Intervention

Patients in this groups will have the positive end expiratory pressure on the ventilator set by the clinician during ventilation and set to a standard positive end expiratory pressure of 5-8 cm H2O during spontaneous breathing trials.

transpulmonary pressure guided positive end expiratory pressure is already approved in United States, European Union for the following indications:

Approved in United States as Transpulmonary Pressure Guided PEEP for:

• Mechanical ventilation management in obese patients
• ARDS management

Approved in European Union as Transpulmonary Pressure Guided PEEP for:

• Mechanical ventilation optimization in obese patients
• ARDS treatment

Who Is Running the Clinical Trial?

University of Mississippi Medical Center

Lead Sponsor

Trials

185

Recruited

200,000+

Published Research Related to This Trial

In a study of 29 obese patients with acute respiratory distress syndrome (ARDS), using esophageal manometry to guide positive end-expiratory pressure (PEEP) titration significantly increased PEEP from 12 to 20 cm H2O and decreased driving pressure from 15 to 13 cm H2O, indicating improved lung mechanics.

This method also led to improved oxygenation, as evidenced by a decrease in the required fraction of inspired oxygen (Fio2) from 0.8 to 0.6 and an increase in the oxygen saturation/Fio2 (S/F) ratio from 120 to 165, demonstrating the efficacy of transpulmonary pressure-guided ventilation in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Review of Transpulmonary Pressure Guided Positive End-Expiratory Pressure Titration for Mechanical Ventilation in Class II and III Obesity. Liou, J., Doherty, D., Gillin, T., et al.[2023]

A new method for measuring esophageal pressure using an air-filled catheter without a balloon has been developed, which is simple, inexpensive, and reproducible, making it easier to implement in intensive care units.

This method was validated against the traditional balloon catheter in both laboratory and clinical settings, showing high accuracy and reliability for monitoring transpulmonary pressure in mechanically ventilated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel method of transpulmonary pressure measurement with an air-filled esophageal catheter. Massion, PB., Berg, J., Samalea Suarez, N., et al.[2021]

In a study of 105 patients on mechanical ventilation, obese individuals had significantly higher esophageal pressure (Pes) compared to non-obese individuals, indicating a greater risk of alveolar collapse due to high pleural pressure.

Applying a Pes-guided PEEP protocol in obese patients could lead to higher PEEP settings than standard empirical methods, suggesting that personalized PEEP adjustments may improve ventilator outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Esophageal Pressures in Mechanically Ventilated Obese Patients. Thind, GS., Mireles-Cabodevila, E., Chatburn, RL., et al.[2023]

In a study of 20 obese patients on mechanical ventilation, using transpulmonary pressure (PL) to guide lung-protective ventilation (LPV) settings led to improved pulmonary mechanics and oxygenation after 24 hours, including higher median PEEP and respiratory system compliance.

PL-guided LPV resulted in lower driving pressure and improved oxygenation levels compared to non-PL-guided settings, suggesting that this approach may enhance ventilation strategies for patients with high pleural pressures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpulmonary Pressure-Guided Lung-Protective Ventilation Improves Pulmonary Mechanics and Oxygenation Among Obese Subjects on Mechanical Ventilation. Rowley, DD., Arrington, SR., Enfield, KB., et al.[2023]

In pediatric acute respiratory distress syndrome (PARDS), adjusting positive end-expiratory pressure (PEEP) can enhance oxygenation and lung compliance, but the optimal PEEP level is still unclear.

Real-time esophageal pressure monitoring allowed for personalized adjustments of PEEP in a PARDS patient, potentially improving aeration and oxygenation while avoiding lung overdistension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Transpulmonary Pressure Monitoring in the Management of Extrapulmonary Pediatric Acute Respiratory Distress Syndrome With multi organ dysfunction syndrome (MODS): Are We Peepophobic? Pandey, M., Gupta, D., Gupta, N., et al.[2020]

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]

Esophageal pressure (Pes) monitoring is a promising method for guiding ventilation support, as it helps differentiate between lung and chest wall mechanics and estimates transpulmonary pressure, which is crucial for preventing lung injury.

Using both absolute expiratory Pes values and tidal Pes differences can effectively adjust ventilation settings, potentially reducing the risk of ventilator-induced lung injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Aspects of Esophageal Pressure Monitoring in Patients with Acute Respiratory Distress Syndrome. Dostal, P., Dostalova, V.[2023]

In morbidly obese patients, the measurement of transpulmonary pressure (PL) during mechanical ventilation showed progressive increases, which were initially thought to indicate improved conditions.

However, these increases were actually artifacts caused by leaks in the pressure probes, leading to an underestimation of esophageal pressure (Pes) and an overestimation of PL, highlighting the importance of accurate pressure measurement in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief report: leaking esophageal probe may lead to false ventilator settings when guiding positive end-expiratory pressure by transpulmonary pressure. Eichler, L., Truskowska, K., Goetz, AE., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9061141/

Retrospective Review of Transpulmonary Pressure Guided ... PL-guided PEEP titration in obese patients can be used to safely titrate PEEP and decrease DP, resulting in improved oxygenation. Keywords: ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35510150/

Retrospective Review of Transpulmonary Pressure Guided ... Conclusions: PL-guided PEEP titration in obese patients can be used to safely titrate PEEP and decrease DP, resulting in improved oxygenation.

3. researchgate.net researchgate.net/publication/360265370_Retrospective_Review_of_Transpulmonary_Pressure_Guided_Positive_End-Expiratory_Pressure_Titration_for_Mechanical_Ventilation_in_Class_II_and_III_Obesity

Retrospective Review of Transpulmonary Pressure Guided ... Transpulmonary pressure (PL) obtained via esophageal manometry may be more beneficial to titrating positive end-expiratory pressure (PEEP) in ...

4. semanticscholar.org semanticscholar.org/paper/984bfe2f8a036037dc5012f49613c83041fb4ee7

Retrospective Review of Transpulmonary Pressure Guided ... PL-guided PEEP titration in obese patients can be used to safely titrate PEEP and decrease DP, resulting in improved oxygenation andTranspulmonary pressure ...

5. apsf.org apsf.org/article/advanced-respiratory-monitoring-therapies-in-the-operating-room-a-new-frontier-for-obese-patients/

Advanced Respiratory Monitoring Therapies in the ... Counterbalancing the increase in pleural pressure by providing positive end expiratory pressure (PEEP) is essential to avoid negative transpulmonary pressure ...

6. semanticscholar.org semanticscholar.org/paper/Effect-of-positive-end-expiratory-pressure-guided-a-Nguyen-Trieu/49d6e77b2874126ffe574fb6b30034a8850a97b2

Effect of positive end-expiratory pressure guided by ... The findings suggest that esophageal manometry is a minimally invasive tool for setting PEEP-guided PL-exp and shown to improve oxygenation and respiratory ...