Assisted or Controlled Ventilation in Ards (Ascovent)

NCT03245684 | Unknown

• 1 other identifier: ASCOVENT
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pulmonary concentration of inflammation mediators (broncho-alveolar lavage: BAL)

  Dosage of inflammatory mediators (tumor necrosis factor-α soluble receptors, interleukin-6, interleukin-8 and interleukin-1β and interleukin-1 receptor antagonist)

  96 hours

Secondary Outcomes (1)

• Systemic concentration of inflammation mediators (plasma)

  96 hours

Other Outcomes (2)

• Number of ventilator-free days (VFDs) during the 28 days immediately after randomization

  28 days

• Relationship between cytokine concentration and trans-pulmonary pressure

  96 hours

Study Arms (2)

Pressure Support Ventilation

EXPERIMENTAL

after 48h of controlled ventilation the patient randomised in this arm will desedated and switched on 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. assessment of inflammatory response during PSV

Diagnostic Test: assessment of inflammatory response during PSV

Controlled Mechanical Ventilation

ACTIVE COMPARATOR

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

Diagnostic Test: assessment of inflammatory response during PSV

Interventions

assessment of inflammatory response during PSV DIAGNOSTIC_TEST

assessment cytokines level in BAL and plasma

Controlled Mechanical Ventilation; Pressure Support Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age who:
• Are intubated less than 24 hours since meeting the Berlin definition criteria for ARDS.
• Have a commitment to full support;

You may not qualify if:

• Intubation and mechanical ventilation (any form) for \> 24 hours;
• Acute brain injury with Glasgow coma scale (GCS) \<7;
• Body mass index \> 40;
• Age \< 18 years;
• Neuromuscular disease that impairs ability to ventilate without assistance;
• Severe chronic respiratory disease;
• Burns \> 40% total body surface area;
• Malignancy or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%;
• Allogeneic bone marrow transplant within the last 5 years;
• Chronic respiratory condition making patient respirator dependent;
• Patient, surrogate, or physician not committed to full support;
• Acute myocardial infarction or acute coronary syndrome within 30 days;
• Moribund patient: not expected to survive 24 hours;
• No consent/inability to obtain consent

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dirigente medico I livello ( Medical Division of Anestesia andintensive care unit)

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 10, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 10, 2017

Record last verified: 2017-08