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PEEP and Spontaneous Breathing During ARDS (EARDS)

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ClinicalTrials.gov Identifier: NCT04241874
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Other: Mechanical Ventilation Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Positive End-expiratory Pressure With and Without Inspiratory Synchronization During Moderate to Severe ARDS
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Low PEEP and full inspiratory synchronization
PEEP = 5 cmH2O + clinically selected pressure support (PSVclin)
Other: Mechanical Ventilation
Respiratory support through mechanical ventilator

Experimental: High PEEP and full inspiratory synchronization
PEEP = 15 cmH2O + clinically selected pressure support (PSVclin)
Other: Mechanical Ventilation
Respiratory support through mechanical ventilator

Experimental: Low PEEP and inspiratory desynchronization
PEEP = 5 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O)
Other: Mechanical Ventilation
Respiratory support through mechanical ventilator

Experimental: High PEEP and inspiratory desynchronization
PEEP = 15 cmH2O + bilevel positive airway pressure (Respiratory rate 15 breaths/minute, inspiratory time=1 sec, Inspiratory pressure=PSVclin+PEEP, PS=0 cmH2O)
Other: Mechanical Ventilation
Respiratory support through mechanical ventilator




Primary Outcome Measures :
  1. Inspiratory effort [ Time Frame: 45 minutes ]
    The negative deflection in esophageal pressure during inspiration


Secondary Outcome Measures :
  1. Oxygenation [ Time Frame: 45 minutes ]
    Ratio of PaO2 to FiO2

  2. Respiratory mechanics [ Time Frame: 45 minutes ]
    Respiratory mechanics assessed by end-inspiratory occlusion

  3. Lung mechanics [ Time Frame: 45 minutes ]
    Respiratory mechanics assessed by esophageal pressure monitoring during an end-inspiratory occlusion

  4. Work of breathing [ Time Frame: 45 minutes ]
    Esopghageal pressure pressure-time product per minute

  5. Respiratory rate [ Time Frame: 45 minutes ]
    Respiratory rate per minute

  6. Regional Tidal volume distribution [ Time Frame: 45 minutes ]
    Distribution of tidal volume in the different lung zones, assessed by electrical impedance tomography

  7. Alveolar recruitment [ Time Frame: 45 minutes ]
    Change in end-expiratory lung impedance, assessed by electrical impedance tomography

  8. Pendelluft [ Time Frame: 45 minutes ]
    Occurrence of intra-tidal shift of gas within different lung regions at beginning of inspiration

  9. Carbon dioxide [ Time Frame: 45 minutes ]
    Blood carbon dioxide, as assessed by arterial blood gas analysis

  10. Tidal volume [ Time Frame: 45 minutes ]
    Average Tidal volume received by the patient

  11. Dynamic transpulmonary driving pressure [ Time Frame: 45 minutes ]
    The average positive swing in transpulmonary driving pressure during tidal breathing



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (a) ARDS according to the Berlin definition (ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg);
  • (b) assisted ventilation, as prescribed by the attending physician
  • (c) intense inspiratory effort, defined as a negative deflection in the airway pressure equal or greater than 13 cmH2O in the first breath recorded during an end-expiratory occlusion

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241874


Contacts
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Contact: Giuseppe Bello, MD +39063015 ext 4490 gsppbll@gmail.com

Locations
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Italy
Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome, Italy
Contact: Domenico L Grieco, MD       dlgrieco@ymail.com   
Sub-Investigator: Domenico L Grieco, MD         
Principal Investigator: Giuseppe Bello, MD         
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
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Principal Investigator: Giuseppe Bello, MD Fondazione Policlinico A. Gemelli IRCCS
Study Director: Massimo Antonelli, MD Fondazione Policlinico A. Gemelli IRCCS
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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT04241874    
Other Study ID Numbers: EARDS
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual patient data will be made available upon a reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury