HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS

NCT07423520 | Not Yet Recruiting

• 1 other identifier: 7795
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The management ARDS relies on ventilatory strategies aimed at limiting ventilator-induced lung injury (VILI). The setting of PEEP is still subject of debate, as randomized clinical trials comparing standardized higher versus lower PEEP strategies failed to demonstrate a clear survival advantage. Only few studies explored the hemodynamic effects of various PEEP levels depending on lung recruitability. Furthermore, the role of PEEP-mediated lung collapse and overdistention on patients' hemodynamics has yet to be elucidated. In this physiologic study, the association between EIT-measured lung collapse and overdistention and cardiac function will be explored, accounting for the individual potential for lung recruitment, partitioned respiratory mechanics and cardiac preload responsiveness. Three PEEP levels will be tested in a randomized, crossover fashion: PEEP corresponding to the crossing point between lung collapse and overdistention, PEEP associated with low lung collapse, PEEP associated with low lung overdistention.

Conditions

ARDS; AHRF

Keywords

ARDS; AHRF; acute respiratory distress syndrome; PEEP; collapse; overdistention; hemodynamics; heart-lung interactions; mechanical ventilation; randomized crossover trial

Outcome Measures

Primary Outcomes (4)

• Impact of lung collapse on cardiac output

  Evaluation of the relative contribution of lung collapse (arbitrary units) on patients' cardiac output at different PEEP levels (L/min)

  Assesment performed at the end of each of the three 30 minute steps

• Impact of lung collapse on pulmonary vascular resistance

  Evaluation of the relative contribution of lung collapse (arbitrary units) on pulmonary vascular resistance (dyn·s/cm\^5) at different PEEP levels

  Assesment performed at the end of each of the three 30 minute steps

• Impact of lung overdistention on cardiac output

  Evaluation of the relative contribution of lung overdistention (arbitrary units) on patients' cardiac output at different PEEP levels (L/min)

  Assesment performed at the end of each of the three 30 minute steps

• Impact of lung overdistention on pulmonary vascular resistance

  Evaluation of the relative contribution of lung overdistention (arbitrary units) on pulmonary vascular resistance (dyn·s/cm\^5) at different PEEP levels

  Assesment performed at the end of each of the three 30 minute steps

Secondary Outcomes (9)

• Correlation between potential for lung recruitment and PEEP-induced changes in cardiac output

  Assessment at the end of each of the three 30 minute steps

• Correlation between potential for lung recruitment and PEEP-induced changes in pulmonary vascular resistance

  Assesment performed at the end of each of the three 30 minute steps

• PEEP-induced effects on cardiac output in cardiac preload responsive vs. nonresponsive patients

  Assesment performed at the end of each of the three 30 minute steps

• PEEP-induced effects on pulmonary vascular resistance in cardiac preload responsive vs. nonresponsive patients

  Assesment performed at the end of each of the three 30 minute steps

• Relationship between transpulmonary pressures and central venous pressure variations

  At the end of each of the three 30 minute steps

Study Arms (3)

Lung collapse and overdistention crossing point PEEP

EXPERIMENTAL

Other: Change in PEEP

Low lung collapse PEEP

EXPERIMENTAL

Other: Change in PEEP

Low lung overdistention PEEP

EXPERIMENTAL

Other: Change in PEEP

Interventions

Change in PEEP OTHER

Patients will undergo a decremental PEEP trial to determine the crossing-point PEEP. Secondly, three PEEP levels (low collapse PEEP, low overdistention PEEP and crossing point between lung collapse and overdistention PEEP) will be compared in a randomized order with 30-minute steps

Low lung collapse PEEP; Low lung overdistention PEEP; Lung collapse and overdistention crossing point PEEP

Eligibility Criteria

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

You may qualify if:

• acute respiratory failure with onset \< 1 week from a predisposing risk factor, such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock;
• bilateral opacities on chest radiography and computed tomography or bilateral B lines and/or consolidations on lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses;
• pulmonary edema not exclusively or primarily attributable to cardiogenic pulmonary edema/fluid overload, and hypoxemia/gas exchange abnormalities not primarily attributable to atelectasis;
• PaO2/FiO2 ratio ≤ 200 during invasive controlled mechanical ventilation;

You may not qualify if:

• age \<18 years;
• pregnancy;
• signs of barotrauma or documented pneumothorax;
• severe tachycardia (HR \> 120 bpm) and severe lacticaemia (lac \> 4 mmol/L)
• pre-existing decompensated heart failure (NYHA class 3-4 and/or documented left ventricular ejection fraction \< 35%);
• contraindications to EIT placing (open chest wounds, presence of cardiac pacemaker);
• intubation as a result of an acute exacerbation of chronic pulmonary disease;
• contraindications to esophageal balloon placement (high bleeding risk, esophageal varices).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, Rome, 00168, Italy

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Unconsciousness

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Domenico Luca Grieco, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico Luca Grieco, MD

CONTACT

+393397681623; dlgrieco@outlook.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Model Details: Randomized crossover trial

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 20, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

IT (1)