Physiological Effects of Controlled vs. Assisted Ventilation During Moderate-to-severe ARDS (PEARL Study)

NCT07315815 | Not Yet Recruiting

• 1 other identifier: 7648
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: In patients with acute hypoxemic respiratory failure or ARDS, mechanical ventilation is often required. Two common strategies are pressure support ventilation (PSV), which allows spontaneous breathing, and volume-controlled ventilation (VCV), which delivers fixed tidal volumes. Although PSV can improve comfort, strong inspiratory efforts may cause excessive lung inflation and increase the risk of ventilator-induced lung injury (VILI). In contrast, VCV with muscle paralysis ensures full control over tidal volume and driving pressure, potentially offering better lung protection. Hypothesis: The study will help determine whether a controlled ventilation strategy - with or without volume adjustments and with or without muscle paralysis - provides superior lung protection compared to PSV in hypoxemic patients with intense inspiratory effort. Methods: This prospective physiological study will be performed in the ICU of Fondazione Policlinico Universitario A. Gemelli (Rome, Italy) and will include 20 moderate to severe ARDS patients. Each patient will undergo four 30-minute ventilation phases: PSV with clinical PEEP; VCV at 6 ml/kg predicted body weight (PBW); VCV with muscle paralysis and Vt equal to PSV; VCV with muscle paralysis and Vt adjusted to keep driving pressure ≤14 cmH₂O. During each phase, data on gas exchange, respiratory mechanics, inspiratory effort, and regional ventilation (via electrical impedance tomography) will be collected. Endpoints: Primary: Regional tidal volume distribution during VCV vs. PSV. Secondary: Transpulmonary driving pressure, dorsal ventilation fraction, and pendelluft occurrence. Expected Impact: By comparing assisted and controlled ventilation under different conditions, the study aims to clarify which strategy better balances patient comfort, effective ventilation, and lung protection in ARDS patients with high respiratory drive.

Conditions

Ventilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (1)

• Regional tidal volume during volume-controlled vs. pressure support ventilation

  1 year

Eligibility Criteria

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

Study Population

Intubated patients fulfilling ARDS criteria and undergoing assisted ventilation as per clinical decision will be enrolled in case of moderate-to-severe hypoxemia.

You may qualify if:

• Intubated patients fulfilling moderate-to-severe ARDS (ratio of arterial partial pressure of oxygen to fraction of inspired oxygen.
• Undergoing assisted ventilation as per clinical decision

You may not qualify if:

• refusal to participate, age younger than 18 years old, pregnancy
• contraindication to 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 (e.g., recent upper-gastrointestinal surgery, esophageal varices).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share