Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07248995

The Contribution of the Combination of Transthoracic and Transcranial Ultrasonography to the Titration of Positive End-expiratory Pressure in Patients With Acute Respiratory Distress Syndrome and Acute Brain Injury

Led by Theodoros Schizodimos · Updated on 2025-12-31

30

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate whether combining lung and brain ultrasonography helps select the best positive end-expiratory pressure (PEEP) for critically ill patients who are mechanically ventilated with acute respiratory distress syndrome (ARDS) and acute brain injury (ABI). The study focuses on creating an individualized ventilation strategy that protects the brain while managing lung function. This is important because improving lung aeration may affect brain pressure and blood flow. Participants will undergo a stepwise increase of PEEP at four levels: 5, 8, 12, and 16 cmH2O. After each increase, lung ultrasound will assess lung aeration patterns using the Lung Ultrasound Score, and transcranial Doppler ultrasonography will evaluate cerebral blood flow and intracranial pressure indicators. Researchers will record intracranial pressure, brain oxygen levels, respiratory mechanics, and arterial blood gases during the approximately 120-minute procedure. During the study, each participant serves as their own control. Researchers will monitor lung and brain function continuously to find the optimal PEEP level that balances lung and brain needs. They will measure differences in PEEP levels guided by lung and brain ultrasound, and follow clinical outcomes up to 90 days after intervention. The study includes safety monitoring and detailed assessments to develop a brain-protective ventilation approach for these critically ill patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Severe acute brain injury such as traumatic brain injury, subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke
  • Development of acute respiratory distress syndrome (ARDS) according to Berlin criteria within 10 days of ICU admission
Not Eligible

You will not qualify if you...

  • Severe chronic brain diseases
  • Brain tumor or central nervous system 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2 hours

Participants undergo a stepwise increase of positive end-expiratory pressure (PEEP) at four levels. After each change, lung ultrasound and transcranial doppler assessments are performed along with recording of intracranial pressure, brain oxygen partial pressure, and mechanical ventilation parameters. Arterial blood gases are taken 20 minutes after each PEEP adjustment.

1 intensive treatment session

Follow-up

Duration - Up to 90 days

Participants are monitored for clinical outcomes related to PEEP differences until ICU and hospital discharge, up to 90 days.

Visits as part of routine ICU and hospital care

Trial Site Locations

Total: 1 location

1

George Papanikolaou General Hospital

Thessaloniki, Greece, 54248

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Research Team

T

Theodoros Schizodimos, MD

G

Georgia Pitsiou, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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