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

Trial Summary

What is the purpose of this trial?

This study will look at whether accounting for the amount of pressure generated by the chest wall and abdomen in a obese patient, using a measurement called transpulmonary pressure, can help shorten the amount of time patients spend on the ventilator. By decreasing the amount of time patients spend on the ventilator, they are less likely to develop complications such as infections, weakness or more procedures.

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 data supports the effectiveness of transpulmonary pressure-guided ventilation weaning for obesity-related respiratory issues?

Research suggests that using esophageal pressure to guide PEEP settings may help improve lung function in obese patients by better managing the pressure in the lungs, although more studies are needed to confirm its benefits specifically for obesity-related respiratory issues. ^{1 2 3 4 5}

Is transpulmonary pressure-guided ventilation safe for humans?

Transpulmonary pressure-guided ventilation, which uses esophageal pressure monitoring, is considered minimally invasive and has been used to guide ventilation support in various conditions, including acute respiratory distress syndrome. It helps in adjusting ventilation settings to potentially reduce the risk of lung injury during mechanical ventilation. ^{1 2 3 5 6}

How is transpulmonary pressure-guided PEEP different from other treatments for obesity-related respiratory issues?

Transpulmonary pressure-guided PEEP is unique because it uses esophageal pressure measurements to tailor the ventilation settings specifically for obese patients, potentially improving lung function and oxygen levels more effectively than traditional methods. This approach is particularly beneficial for patients with high pleural pressures, which are common in obesity, and aims to optimize mechanical ventilation by individualizing treatment. ^{1 2 3 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

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]

References

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

Evaluation of Esophageal Pressures in Mechanically Ventilated Obese Patients. [2023]

2. United States 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. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Novel method of transpulmonary pressure measurement with an air-filled esophageal catheter. [2021]

4. United States 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. [2021]

5. United States 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? [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Practical Aspects of Esophageal Pressure Monitoring in Patients with Acute Respiratory Distress Syndrome. [2023]

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

Transpulmonary Pressure-Guided Lung-Protective Ventilation Improves Pulmonary Mechanics and Oxygenation Among Obese Subjects on Mechanical Ventilation. [2023]

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

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