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

NCT06119516 | Recruiting

• 4 other identifiers: APHP2208242023-A01044-41PHRC21-0254DR-2023-130
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

ARDS, Human; Obesity, Morbid

Keywords

ARDS, Human; Obesity, morbid; Mechanical Ventilation; Transpulmonary pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The ratio between the arterial partial pressure of oxygen (PaO2) on the inspired fraction of oxygenFiO2): PaO2/FiO2 ratio

  during the intervention

• The mortality rate of included patients.

  Mortality rate will be determined at end of ICU stay, at Day 28 and at Day 90.

• Number of days alive and free for invasive mechanical ventilation

  The numbers of days alive and free for invasive mechanical ventilationwill be determined at Day-28 and Day-90

• Occurrence of pneumothorax

  during the intervention

• Occurence of severe hemodynamic compromise defined by the need of vasoactive treatment

  during the intervention

Study Arms (1)

Esophageal pressure-guided strategy,

EXPERIMENTAL

The second generation esogastric multifunction Nutrivent catheter (SIDAM, Mirandola, Italy) will be used to monitor esophageal and gastric pressures during several days. Ventilator settings will be adjusted to the evaluated esophageal pressure-guided strategy, aiming to obtain a slightly positive transpulmonary pressure at the end of expiration.

Other: Esophageal pressure-guided strategy,

Interventions

Esophageal pressure-guided strategy, OTHER

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.

Esophageal pressure-guided strategy,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, France: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (5)

CHU Angers

Angers, 49933, France

RECRUITING

Hôpital Bicêtre, AP-HP

Le Kremlin-Bicêtre, 94270, France

RECRUITING

Hôpital de la Croix-Rousse, HCL

Lyon, 69004, France

RECRUITING

AP-HP, Hôpital Européen Georges Pompidou

Paris, 75015, France

RECRUITING

CHU la Milétrie

Poitiers, 86021, France

RECRUITING

Related Publications (5)

• 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.

  PMID: 34236478 BACKGROUND

• 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 Oct 1;133(4):867-878. doi: 10.1097/ALN.0000000000003444.

  PMID: 32701573 RESULT

• 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, Berra L; investigators of the lung rescue team. A lung rescue team improves survival in obesity with acute respiratory distress syndrome. Crit Care. 2020 Jan 15;24(1):4. doi: 10.1186/s13054-019-2709-x.

  PMID: 31937345 RESULT

• 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):1049-1058. doi: 10.4187/respcare.08686. Epub 2021 Apr 20.

  PMID: 33879565 RESULT

• 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 Risk-based and Mechanistic Reanalysis of the EPVent-2 Trial. Am J Respir Crit Care Med. 2021 Nov 15;204(10):1153-1163. doi: 10.1164/rccm.202009-3539OC.

  PMID: 34464237 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome; Obesity, Morbid

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Luc MD Diehl, PhD

  AP-HP, Hôpital Européen Georges Pompidou, Paris

  STUDY CHAIR

Central Study Contacts

Joséphine Braun

CONTACT

01 44 84 17 38; josephine.braun@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 7, 2023
• Study Start: April 4, 2024
• Primary Completion (Estimated): April 4, 2027
• Study Completion (Estimated): July 4, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (5)