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Assisted or Controlled Ventilation in Ards (Ascovent)

Assessment of the Inflammatory Response Associated With the Increase of Transpulmonary Pressure in Ipoxiemic Patients During Assisted Mechanical Ventilation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03245684
Acronym
ASCOVENT
Enrollment
40
Registered
2017-08-10
Start date
2017-09-01
Completion date
2019-09-01
Last updated
2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Inflammatory Response, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury

Keywords

ARDS, Ventilator-induced Lung Injury, cytokines, mechanical ventilation

Brief 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.

Detailed 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)

Interventions

DIAGNOSTIC_TESTassessment of inflammatory response during PSV

assessment cytokines level in BAL and plasma

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients \> 18 years of age who: 1. Are intubated less than 24 hours since meeting the Berlin definition criteria for ARDS. 2. Have a commitment to full support; 3. Have no

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary concentration of inflammation mediators (broncho-alveolar lavage: BAL)96 hoursDosage of inflammatory mediators (tumor necrosis factor-α soluble receptors, interleukin-6, interleukin-8 and interleukin-1β and interleukin-1 receptor antagonist)

Secondary

MeasureTime frameDescription
Systemic concentration of inflammation mediators (plasma)96 hoursThe concentrations of the same mediators (tumor necrosis factor-α soluble receptors, interleukin-6, interleukin-8 and interleukin-1β and interleukin-1 receptor antagonist) in a sample of 10 ml of blood taken from a central venous line will be analyzed

Other

MeasureTime frameDescription
Number of ventilator-free days (VFDs) during the 28 days immediately after randomization28 days
Relationship between cytokine concentration and trans-pulmonary pressure96 hoursEnd-expiratory and end-inspiratory occlusions will be performed. End-inspiratory Plateau Pressure. Pplat of the respiratory system (Pplatrs) will be the value of PAW after an end-inspiratory occlusion. End-inspiratory chest wall plateau pressure (PplatCW) will be measured as the variation in PES between end-expiratory and end-inspiratory occlusions; end-inspiratory plateau pressure of the lung (Pplatl) were estimated as Pplatrs - PplatCW

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026