Contribution of Transthoracic and Transcranial Ultrasonography to the Titration of PEEP in Patients With ARDS and ABI

NCT07248995 | Recruiting

• 1 other identifier: 10957
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will investigate whether the combined use of lung and brain ultrasonography is useful in selecting the optimal positive end-expiratory pressure in mechanically ventilated critically ill patients with acute respiratory distress syndrome and acute brain injury, aiming at an individualized, brain-protective ventilation strategy.

Conditions

Acute Respiratory Distress Syndrome (ARDS); Acute Brain Injury

Outcome Measures

Primary Outcomes (1)

• Difference in PEEP Levels Between Optimal PEEP (LUS-Guided) and Safe PEEP (TCD and Respiratory Mechanics-Guided)

  Optimal PEEP is determined using the Lung Ultrasound Score (LUS; aeration score 0-36), while Safe PEEP is determined based on Transcranial Doppler (TCD) measurements (Pulsatility Index, mean flow velocity) and respiratory mechanics parameters (driving pressure, plateau pressure, compliance). The outcome represents the difference between Optimal PEEP and Safe PEEP expressed in cmH₂O. Unit of Measure: cmH₂O

  From the start of the intervention until completion of the PEEP titration procedure, within approximately 120 minutes from intervention initiation.

Secondary Outcomes (1)

• Correlation Between PEEP Difference and Clinical Outcomes

  From the intervention until ICU discharge and hospital discharge, assessed up to 90 days

Study Arms (1)

Stepwise PEEP Elevation Protocol Arm

EXPERIMENTAL

All participants with ARDS and ABI will undergo a protocolized stepwise increase of PEEP at four levels. Each participant will serve as their own control.

Procedure: Stepwise Positive End-Expiratory Pressure (PEEP) Increase Protocol

Interventions

Stepwise Positive End-Expiratory Pressure (PEEP) Increase Protocol PROCEDURE

The intervention includes a stepwise increase in PEEP level from 5 to 8, 12 and 16 centimeter of water (cmH2O). After each PEEP level change, lung ultrasound and transcranial doppler will be performed, and the values of intracranial pressure (ICP) and brain oxygen partial pressure (PO2), as well as the mechanical ventilation parameters, will be recorded. Arterial blood gases will be taken 20 minutes later.

Stepwise PEEP Elevation Protocol Arm

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Severe acute brain injury (e.g., traumatic brain injury, subarachnoid hemorrhage, intracerebral hemorrhage, acute ischemic stroke)
• Development of ARDS (according to Berlin criteria) within the first 10 days of ICU admission

You may not qualify if:

• Severe chronic brain diseases
• Brain tumor or central nervous system (CNS) infection
• Severe chronic pulmonary or cardiovascular disease
• Severe coagulopathy
• Undergoing decompressive craniectomy
• Lack of invasive neuromonitoring
• Withdrawal of life-sustaining treatment
• Poor acoustic window in ultrasound

Sponsors & Collaborators

• Theodoros Schizodimos: lead

Study Sites (1)

George Papanikolaou General Hospital

Thessaloniki, 54248, Greece

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Brain Injuries

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Theodoros Schizodimos, MD

  2nd Intensive Care Unit, George Papanikolaou General Hospital of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodoros Schizodimos, MD

CONTACT

+306973439717; teoschizo@gmail.com

Georgia Pitsiou, PhD

CONTACT

gpitsiou@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Theodoros Schizodimos

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)