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Completed

NCT Number: NCT04241874

PEEP and Spontaneous Breathing During ARDS

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mechanical ventilation

Other

Respiratory support through mechanical ventilator

Primary outcomes

  1. Inspiratory effort

    Time frame: 45 minutes

    The negative deflection in esophageal pressure during inspiration

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Effects of Positive End-expiratory Pressure With and Without Inspiratory Synchronization During Moderate to Severe ARDS

Acronym: EARDS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2020
Registry last updated
Sep 7, 2022

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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