Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.
NCT ID: NCT06119516
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-04-04
2026-07-04
Brief Summary
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• 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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Esophageal pressure-guided strategy,
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-Luc MD Diehl, PhD
Role: STUDY_CHAIR
AP-HP, Hôpital Européen Georges Pompidou, Paris
Locations
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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, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2023-A01044-41
Identifier Type: OTHER
Identifier Source: secondary_id
PHRC21-0254
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DR-2023-130
Identifier Type: OTHER
Identifier Source: secondary_id
APHP220824
Identifier Type: -
Identifier Source: org_study_id
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