Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05259631

Inhalational (Sevoflurane) Versus Intravenous (Propofol) Sedation in Adults With a Moderate Form of ARDS

Acute Respiratory Distress Syndrome Clinical Trial

Official title:
Inhalational (Sevoflurane) Versus Intravenous (Propofol) Sedation in Adults With a Moderate Form of ARDS: A Multicentral Randomized Pilot Trial

Clinical Trial Summary

The American European Consensus Conference (AECC) 1994 defined acute respiratory distress syndrome (ARDS) as an acute inflammatory syndrome manifesting as diffuse pulmonary edema and respiratory failure that cannot be explained by, but may co-exist with, left-sided heart failure. During the sequel Conference of the European Society of Intensive Care Medicine, in 2012 minor changes were made, and since that so-called Berlin definition of ARDS is used worldwide for the description of this severe disease. Three grades of severity were proposed to distinguish ARDS according to the level of hypoxemia with a mortality of 24% in patients with mild ARDS, rising to 48% in those with severe ones. Systemic inflammation is considered to be the main reason of ARDS. Activated neutrophils interact with the alveolar-capillary membrane causing the increasing permeability with the sequence lung edema's development. Inflammatory exudate inactivates surfactant leading to collapse and consolidation of distal airspaces with progressive loss of the lung's gas exchange surface area. Unfortunately, systemic inflammatory response syndrome (SIRS) simultaneously inhibits the mechanism of active pulmonary vasoconstriction and allows deoxygenated blood to pass through unventilated areas of the lung boosting the right-to-left shunt. Both mechanisms lead to hypoxemia, which is the main and obligatory feature of ARDS. Actually, endothelial dysfunction and transcapillary leakage seem to be one of the main steps in the development of respiratory failure during ARDS. Last decades it was found out that glycocalyx is also participating in this process too. Thus, it became clear that substances preserving endothelium and glycocalyx from SIRS-causing damage may have a beneficial effect in ARDS treatment. It seems to be crucially important so as the majority of drugs failed to demonstrate any positive effects in terms of ARDS treatment. To the moment we have some evidence, which came from experimental studies, that halogenated anesthetics can preserve glycocalyx against ischemia-reperfusion injury. The primary objective for the multicentral INVERSE Trial will be to determine the effects of inhalational (sevoflurane) versus intravenous (propofol) sedation on P/F ratio on the second day, hospital mortality and ICU (intensive care unit), and in-hospital length of stay in adults with a moderate form of ARDS.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05259631
Study type Interventional
Source Negovsky Reanimatology Research Institute
Contact
Status Suspended
Phase Phase 3
Start date March 14, 2022
Completion date February 25, 2026
View Details
See also
  Status Clinical Trial Phase
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Recruiting NCT05535543 - Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
Completed NCT04695392 - Restore Resilience in Critically Ill Children N/A
Terminated NCT04972318 - Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia N/A
Completed NCT04534569 - Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
Completed NCT04078984 - Driving Pressure as a Predictor of Mechanical Ventilation Weaning Time on Post-ARDS Patients in Pressure Support Ventilation.
Completed NCT04451291 - Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure N/A
Not yet recruiting NCT06254313 - The Role of Cxcr4Hi neutrOPhils in InflueNza
Not yet recruiting NCT04798716 - The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19 Phase 1/Phase 2
Withdrawn NCT04909879 - Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome Phase 2
Terminated NCT02867228 - Noninvasive Estimation of Work of Breathing N/A
Not yet recruiting NCT02881385 - Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation N/A
Completed NCT02545621 - A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
Withdrawn NCT02253667 - Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients N/A
Completed NCT02232841 - Electrical Impedance Imaging of Patients on Mechanical Ventilation N/A
Withdrawn NCT01927237 - Pulmonary Vascular Effects of Respiratory Rate & Carbon Dioxide N/A
Completed NCT01504893 - Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia N/A
Completed NCT02889770 - Dead Space Monitoring With Volumetric Capnography in ARDS Patients N/A
Completed NCT01680783 - Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure N/A
Completed NCT02814994 - Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients N/A