PEEP and Spontaneous Breathing During ARDS

Acute Respiratory Distress Syndrome Clinical Trial

— EARDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241874
• Other study ID #: EARDS
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: September 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Mechanical Ventilation
Respiratory support through mechanical ventilator

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitaro A. Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory effort	The negative deflection in esophageal pressure during inspiration	45 minutes
Secondary	Oxygenation	Ratio of PaO2 to FiO2	45 minutes
Secondary	Respiratory mechanics	Respiratory mechanics assessed by end-inspiratory occlusion	45 minutes
Secondary	Lung mechanics	Respiratory mechanics assessed by esophageal pressure monitoring during an end-inspiratory occlusion	45 minutes
Secondary	Work of breathing	Esopghageal pressure pressure-time product per minute	45 minutes
Secondary	Respiratory rate	Respiratory rate per minute	45 minutes
Secondary	Regional Tidal volume distribution	Distribution of tidal volume in the different lung zones, assessed by electrical impedance tomography	45 minutes
Secondary	Alveolar recruitment	Change in end-expiratory lung impedance, assessed by electrical impedance tomography	45 minutes
Secondary	Pendelluft	Occurrence of intra-tidal shift of gas within different lung regions at beginning of inspiration	45 minutes
Secondary	Carbon dioxide	Blood carbon dioxide, as assessed by arterial blood gas analysis	45 minutes
Secondary	Tidal volume	Average Tidal volume received by the patient	45 minutes
Secondary	Dynamic transpulmonary driving pressure	The average positive swing in transpulmonary driving pressure during tidal breathing	45 minutes