Clinical Trials Logo

Clinical Trial Summary

The present pilot randomized controlled clinical trial will test the hypothesis that in patients with ARDS, fixing ventilator settings to the conventional protective ventilatory strategy (VT 6 ml/kg ideal body weight and Pplat ≤ 30 cmH2O, PEEP according the PEEP/FiO2 table), control modes of mechanical ventilation will be associated to a concentration of pulmonary and systemic inflammatory mediators lower than the concentration of inflammatory mediators observed during assisted modes of mechanical ventilation.


Clinical Trial Description

All patients will be treated according to the sedation protocols and standards of care. Sedation will be guaranteed by continuous infusion of Propofol 2-4 ml / Kg / h, Remifentanil 0.05-0.1 mcg / Kg / min to obtain a RASS scale level of -5 of the RASS. Mio-resolution eventually obtained by a loading dose of 15 mg e.v. followed by a continuous infusion of 37.5 mg / h of besylated Cisatracury, will be reserved for patients with P/F <150.

During a 48 hrs pre-randomization period, control mechanical ventilation will be set with a Tidal Volume (VT) of 6 ml / kg (for ideal weight) and a Pplat limited to 30 cm H2O; inspiratory flow 50-70 l / min with end-of-breath pause of 0.2-0.5 sec, ratio I: E from 1: 1 to 1: 3, respiratory frequency of 20-35 steps to maintain 7.3 <pH <7.5. If the pH is <7.30 the respiratory frequency will increase up to 35 / min; If the pH is> 7.5, the respiratory rate will be progressively reduced to the target pH range. FiO2 and The PEEP will be set according to the ARDSnet table (33)

After 48 hours, the patient will be randomized through one of the following two groups:

Control Mechanical ventilation (CMV): patient's spontaneous activity will be shut done by sedation and/or respiratory muscles paralysis. Volume (during volume control) or pressure (during pressure control), PEEP, FiO2 and respiratory rate will be regulated according the ARDSnet protocol (33).

Pressure Support Ventilation (PSV): patient's spontaneous activity will maintained and sedation will be maintained at a level of Richmond Assessment Sedation Scale (RASS) between -2 and -3. The level of pressure support (including PEEP) will be limited to ≤ 30 cmH2O; the pressure support level will ensure a tidal volume of 6 ml / Kg ideal body weight. PEEP, FiO2 and respiratory rate will be regulated according the ARDSnet protocol (33) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03245684
Study type Interventional
Source University of Roma La Sapienza
Contact
Status Not yet recruiting
Phase N/A
Start date September 1, 2017
Completion date September 1, 2019

See also
  Status Clinical Trial Phase
Completed NCT04435613 - Clinical and Physiological Assessment of a Nearly Ultra-protective Lung Ventilation Strategy: A Quasi-experimental Preliminary Study in ARDS Patients N/A
Enrolling by invitation NCT05020210 - Effect of Early Treatment With Sivelestat Sodium in ARDS Patients
Completed NCT04468971 - REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia Phase 1
Completed NCT04505592 - Tenecteplase in Patients With COVID-19 Phase 2
Completed NCT04493242 - Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS Phase 2
Withdrawn NCT04909879 - Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome Phase 2
Completed NCT02265198 - Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome N/A
Completed NCT01949272 - Optimization of PEEP for Alveolar Recruitment in ARDS N/A
Not yet recruiting NCT01668368 - Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance N/A
Completed NCT01881061 - Lung Sonography in Patients With Acute Respiratory Distress Syndrome in Intensive Care Unit N/A
Completed NCT00808691 - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit N/A
Completed NCT05035589 - The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
Recruiting NCT04764032 - Right Ventricular Dysfunction in Ventilated Patients With COVID-19
Completed NCT04556513 - Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status
Recruiting NCT06036056 - NMR Based Metabolomics Kinetics in ARDS Patients
Recruiting NCT04503876 - Effects of End-expiratory Positive Pressure Optimization in Intubated Patients With Healthy Lung or Acute Respiratory Distress Syndrome N/A
Recruiting NCT04643691 - Losartan and Spironolactone Treatment for ICU Patients With COVID-19 Suffering From ARDS Phase 2
Completed NCT04395911 - Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections N/A
Not yet recruiting NCT05341687 - Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in COVID-19 ARDS.
Recruiting NCT05056090 - Effect of Prone Positioning on Mortality in Patients With Mild to Moderate Acute Respiratory Distress Syndrome. N/A