AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care
Paris, 75010, France
Location contact
Fabrice VALLEE, MD PhD
CONTACT
Joaquim MATEO, MD
CONTACT
NCT Number: NCT06835881
Given the huge volume of mechanically ventilated patients at risk of ARDS, optimizing hematosis by limiting pulmonary and systemic aggression associated with artificial ventilation techniques is a key objective if we are to further improve the prognosis of ARDS.
With a view to improving cardiopulmonary monitoring in ARDS, modeling using digital twins individualized by nature should ultimately enrich the diagnostic approach by simplifying the technical set-up. Advances in modeling in terms of speed, rendering and results could be applied to personalized monitoring to find the right artificial ventilation setting for the right patient, at the right time.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Paris, 75010, France
Fabrice VALLEE, MD PhD
CONTACT
Joaquim MATEO, MD
CONTACT
During mechanical ventilation (MV) of patients with acute respiratory distress syndrome (ARDS), the application of the most protective ventilatory strategy possible, based on the reduction of volotrauma and the personalized prescription of a positive end-expiratory pressure (PEEP) regime, is the guarantee of clinical benefit, demonstrated in terms of tidal volume in particular (reduced mortality and number of days without mechanical ventilation).
When a benefit for patients with ARDS is found in clinical trials, it is mainly related to a reduction in the damage caused by mechanical ventilation.
Through technological progress mechanical ventilation optimization is guided by advanced monitoring, including measurement of transpulmonary pressure (TPP or LP) and/or functional imaging data (e.g. Electro-impedance Tomography, EIT).
All these monitoring systems are now incorporated in the new generation of ventilators.
This observational study on clinical physiological data is based on the reuse of pseudonymized recorded data in 1st-line care during sequential diagnostic maneuvers based on calibrated variations in PEEP and tidal volume and obtained by advanced respiratory monitoring in the acute phase of ARDS (esophageal manometry and/or EIT) and in accordance with the most recent recommendations.
No specific research procedures are planned for this study. This study will be conducted exclusively on the basis of personal data collected as part of the usual monitoring of a participant with ARDS undergoing advanced respiratory care. The analysis focuses on data recorded during recruitment maneuvers performed as part of care for this type of patient in the ICU.
Participants are informed individually, and their non-objection to the re-use of their data for research purposes is recorded in the file. Where applicable, information is given to the trusted support person/relative/parent if the participant is unable to express his/her wishes and does not object to the re-use of his/her data for research purposes. An information note is given to the patient or the trusted support person/relative/parent
Monitoring data is currently available in the Clinical Research Unit of our Intensive Care Departments, thanks to a data extraction system based on PHILIPS IntelliVue® or Mindray Benevision® monitoring solutions. It should be noted that the Data Warehouse Connect software solution enables all these data to be collected with fine sampling (2 ms for tracings, 1s for digital data), considerably extending the capabilities in terms of data analysis and exploitation. The extraction system is temporally coupled to patient events and medication (doses) administered, thanks to an IntelliSpace Critical Care and Anesthesia (ICCAA) information system that is operational in the ICU.
These data are downloaded onto a secure server with restricted access, then loaded into a database (SQL) for future processing of the pseudonymized data.
The data will be collected as part of routine care and is integrated in compliance with the RGPD.
Demographic data will be collected using the intensive care record (ORBIS or equivalent / computerized patient record).
Aim of the study Does the analysis of advanced monitoring data provide characteristic measured parameters that could help prevent or even reduce ventilator-induced lesions? Can these data be integrated into a model to build a digital twin for practical, simplified monitoring of ventilatory function?
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.
Time frame: Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS
Ventilation/pulmonary perfusion (in %) obtained with the Electro-Impedance Tomography (EIT) data
Time frame: Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.
Time frame: Acquisition and recording of monitoring data up to 5 days of intensive care in the acute phase of ARDS.
Contact information is provided by the study sponsor or research team.
Fabrice VALLEE, MD PhD
CONTACT
Joaquim MATEO, MD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Exploratory Study on the Value of Advanced Respiratory Monitoring Data During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome (ARDS) in Terms of (1) Estimating the Risk of Ventilator Induced Lung Injury (VILI) and (2) the Relationship Between Aeration Benefit and Gas Exchange
Acronym: PULMODEL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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