Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.

Obesity, Morbid Clinical Trial

— TGV-MOA  

Official title:

Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119516
• Other study ID #: APHP220824
• Secondary ID: 2023-A01044-41PH
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2024
• Est. completion date: July 4, 2026

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Joséphine Braun
• Phone: 01 44 84 17 38
• Email: josephine.braun[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test a personalized intervention aiming to optimize the mechanical ventilator settings in morbidly obese patients suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS). The intervention consists of personalized measurements and calculations of the different pressures inside the thorax. The main question to answer is: • Will the evaluated esophageal pressure-guided strategy lead to different mechanical ventilator settings than suggested by a strategy largely used in ARDS patients in France? A specific nasogastric probe permitting to measure esophageal pressure will monitor participants. Esophageal pressure will act as an indicator of the pleural pressure. Other respiratory signals displayed by the mechanical ventilators will also be acquired. Further, ventilator settings will be adjusted to the evaluated esophageal pressure-guided strategy, with possible benefit of this personalized approach.

Description:

The goal of this clinical trial is to test a personalized intervention aiming to optimize the mechanical ventilator settings in morbidly obese patients suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS). Mechanical ventilation is the cornerstone of the ARDS symptomatic treatment. Individualization of mechanical ventilator settings could improve prognosis mainly by preventing or decreasing accumulation of fluid in the lung and hemodynamic impairment. It is likely that class III obesity ARDS patients (defined by body mass index (BMI) > 40 kg/m2), could benefit from a highly personalized approach, based on esophageal pressure monitoring. These patients have significantly higher esophageal pressures, acting as an indicator of pleural pressure, than the general ARDS population, while these patients have rather normal mechanical characteristics of the chest wall. Such features could suggest innovative mechanical ventilator settings, by integrating esophageal pressures values, aiming to obtain a slightly positive transpulmonary pressure at the end of expiration. The intervention consists of personalized measurements and calculations of the different pressures, including the esophageal one, inside the thorax. The main question to answer is: • Will the evaluated esophageal pressure-guided strategy lead to different mechanical ventilator settings, mainly the positive end-expiratory pressure (PEEP) setting, than suggested by a PEEP-strategy largely used in ARDS patients in France? A specific nasogastric probe permitting to measure esophageal pressure will monitor participants. The second generation esogastric multifunction Nutrivent catheter (SIDAM, Mirandola, Italy) will be used. It allows both enteral nutrition of the patients and monitoring of esophageal and gastric pressures during several days. Esophageal pressure will act as an indicator of the pleural pressure. Other respiratory signals displayed by the mechanical ventilators will also be acquired, permitting to calculate the trans-pulmonary pressures. Further, ventilator settings will be adjusted to the evaluated esophageal pressure-guided strategy, with possible benefits of this personalized approach. The main benefits for the research participants will be the application of highly personalized mechanical ventilator settings, aiming mainly to select the best PEEP setting with the goal of optimization of opening the lung while avoiding the respiratory and hemodynamic consequences of excessive lung inflation. Monitoring of the end-inspiratory transpulmonary pressures will help to prevent excessive lung inflation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 4, 2026
• Est. primary completion date: April 4, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient (aged 18 years or older)
• Class III morbid obesity (BMI > 40 kg/m2)
• Moderate or severe ARDS criteria (according to the Berlin definition)
• Less than 72 hours between fulfilling moderate or severe ARDS criteria and inclusion
• Tracheal intubation and invasive mechanical ventilation
• Informed consent (patient, next of kin), with possibility of an emergency procedure with deferred consent
• Covid-19 and non-Covid-19 patients

Exclusion Criteria:

• Contra-indication to nasogastric tube (uncontrolled coagulopathy, severe thrombocytopenia, nasal trauma, esophageal varices)
• Order to limit life-sustaining therapy
• ExtraCorporal Membrane Oxygenation (ECMO) in use
• Invasive mechanical ventilation > 96 hours
• Elevated intracranial pressure
• Active air-leak: pneumothorax, pneumomediastinum
• Pregnancy or breast feeding
• Patient on state medical aid

Related Conditions & MeSH terms

• ARDS, Human
• Obesity, Morbid
• Respiratory Distress Syndrome

Intervention

Other:
• Esophageal pressure-guided strategy,
A catheter-balloon system will be positioned and calibrated in all included patients. The second generation esogastric multifunction Nutrivent catheter (SIDAM, Mirandola, Italy) will be used. It allows both enteral nutrition of the patients and monitoring of esophageal and gastric pressures during several days. A connection line will be inserted between the catheter (either esophageal or gastric balloon port) and the auxiliary pressure port of the mechanical ventilator (General Electric, R860, available in each center). Numeric recording of the respiratory signals will be achieved via the OhmedaCom Research Tool software, helping for centralization of the analyses, therefore ensuring reproducibility of the results.

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Hôpital Bicêtre, AP-HP	Le Kremlin-Bicêtre
France	Hôpital de la Croix-Rousse, HCL	Lyon
France	AP-HP, Hôpital Européen Georges Pompidou	Paris
France	CHU la Milétrie	Poitiers

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (5)

Coudroy R, Vimpere D, Aissaoui N, Younan R, Bailleul C, Couteau-Chardon A, Lancelot A, Guerot E, Chen L, Brochard L, Diehl JL. Prevalence of Complete Airway Closure According to Body Mass Index in Acute Respiratory Distress Syndrome. Anesthesiology. 2020 — View Citation

Diehl JL, Talmor D. When could airway plateau pressure above 30 cmH2O be acceptable in ARDS patients? Intensive Care Med. 2021 Sep;47(9):1028-1031. doi: 10.1007/s00134-021-06472-5. Epub 2021 Jul 8. No abstract available. — View Citation

Florio G, Ferrari M, Bittner EA, De Santis Santiago R, Pirrone M, Fumagalli J, Teggia Droghi M, Mietto C, Pinciroli R, Berg S, Bagchi A, Shelton K, Kuo A, Lai Y, Sonny A, Lai P, Hibbert K, Kwo J, Pino RM, Wiener-Kronish J, Amato MBP, Arora P, Kacmarek RM, — View Citation

Rowley DD, Arrington SR, Enfield KB, Lamb KD, Kadl A, Davis JP, Theodore DJ. Transpulmonary Pressure-Guided Lung-Protective Ventilation Improves Pulmonary Mechanics and Oxygenation Among Obese Subjects on Mechanical Ventilation. Respir Care. 2021 Jul;66(7 — View Citation

Sarge T, Baedorf-Kassis E, Banner-Goodspeed V, Novack V, Loring SH, Gong MN, Cook D, Talmor D, Beitler JR; EPVent-2 Study Group. Effect of Esophageal Pressure-guided Positive End-Expiratory Pressure on Survival from Acute Respiratory Distress Syndrome: A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absolute value of the difference between the PEEP levels determined by esophageal pressure-guided strategy and by the PEEP level indicated by the maximal recruitment arm of the ExPress trial	To demonstrate that the evaluated esophageal pressure-guided strategy leads to significantly and clinically different mechanical ventilator settings (mainly PEEP setting) than the reference strategy.	during the first 24 hours after inclusion
Secondary	The ratio between the arterial partial pressure of oxygen (PaO2) on the inspired fraction of oxygenFiO2): PaO2/FiO2 ratio	To assess the efficacy of the esophageal pressure-guided strategy.	during the intervention
Secondary	The mortality rate of included patients.	To assess the efficacy and safety of the esophageal pressure-guided strategy.	Mortality rate will be determined at end of ICU stay, at Day 28 and at Day 90.
Secondary	Number of days alive and free for invasive mechanical ventilation	To assess the efficacy of the esophageal pressure-guided strategy.	The numbers of days alive and free for invasive mechanical ventilationwill be determined at Day-28 and Day-90
Secondary	Occurrence of pneumothorax	To assess the safety of the esophageal pressure-guided strategy.	during the intervention
Secondary	Occurence of severe hemodynamic compromise defined by the need of vasoactive treatment	To assess the safety of the esophageal pressure-guided strategy.	during the intervention
Secondary	Percentage of included patients with inability to insert the Nutrivent catheter	To assess the feasibility of the esophageal pressure-guided strategy.	during the first 24 hours after inclusion