Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome, Italy
NCT Number: NCT04241874
Prospective, physiological study to systematically assess the effects of high positive end-expiratory pressure (PEEP) with and without inspiratory synchronization in patients with moderate to severe acute respiratory distress syndrome (ARDS) exhibiting intense inspiratory effort while on assisted ventilation.
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All sexes
Interventional
Not applicable
Rome, Italy
This prospective, physiological, randomized, cross-over study will be conducted in the 20-bed general ICU of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. Patients with ARDS will be screened for eligibility. ARDS will be defined according to the Berlin Definition.
Intubated patients fulfilling ARDS criteria, undergoing assisted ventilation as per clinical decision and exhibiting intense inspiratory effort (occlusion pressure equal or greater than 13 cmH2O) will be enrolled.
Patients will be placed in a 30°-45° head up position during all study phases. According to our institution protocol, pressure support setting will be selected by the attending physician to target a predefined tidal volume range of 6-8 mL/kg of predicted body weight (PBW) (female PBW [kg] = 45.5 + 0.91 [cm of height - 152.4]; male PBW [kg] = 50 + 0.91 [cm of height - 152.4]).The lowest pressure support level allowed will be 7 cmH2O, even if Vt <8 ml/Kg PBW is not achieved.
In each patient, four different ventilator settings will be applied in a random order. Each step will last 45 minutes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pregnancy, clinically documented barotrauma, contraindication to electrical impedance tomography (EIT) use (e.g., presence of pacemaker or automatic implantable cardioverter defibrillator), impossibility to place the EIT belt in the right position (e.g., presence of surgical wounds dressing), and any contraindication to the insertion of a nasogastric tube (eg, recent upper-gastrointestinal surgery, esophageal varices), chest tubes with active air leaks, fever.
Respiratory support through mechanical ventilator
Time frame: 45 minutes
The negative deflection in esophageal pressure during inspiration
Time frame: 45 minutes
Ratio of PaO2 to FiO2
Time frame: 45 minutes
Respiratory mechanics assessed by end-inspiratory occlusion
Time frame: 45 minutes
Respiratory mechanics assessed by esophageal pressure monitoring during an end-inspiratory occlusion
Time frame: 45 minutes
Esopghageal pressure pressure-time product per minute
Time frame: 45 minutes
Respiratory rate per minute
Time frame: 45 minutes
Distribution of tidal volume in the different lung zones, assessed by electrical impedance tomography
Time frame: 45 minutes
Change in end-expiratory lung impedance, assessed by electrical impedance tomography
Time frame: 45 minutes
Occurrence of intra-tidal shift of gas within different lung regions at beginning of inspiration
Time frame: 45 minutes
Blood carbon dioxide, as assessed by arterial blood gas analysis
Time frame: 45 minutes
Average Tidal volume received by the patient
Time frame: 45 minutes
The average positive swing in transpulmonary driving pressure during tidal breathing
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Effects of Positive End-expiratory Pressure With and Without Inspiratory Synchronization During Moderate to Severe ARDS
Acronym: EARDS
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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