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

NCT ID: NCT07248995

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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The present study aims to evaluate whether the combined use of lung ultrasonography and brain ultrasonography can assist in determining the optimal positive end-expiratory pressure (PEEP) in mechanically ventilated, critically ill patients with acute respiratory distress syndrome (ARDS) and acute brain injury (ABI). In patients with concomitant respiratory and neurological injury, selecting an appropriate PEEP level is particularly challenging, as strategies that improve lung aeration may simultaneously increase intracranial pressure or compromise cerebral hemodynamics.

Lung ultrasound will be used to assess aeration patterns and guide lung recruitment through the Lung Ultrasound Score (LUS), while transcranial Doppler ultrasonography will be used to evaluate cerebral blood flow and intracranial pressure surrogates, such as the pulsatility index. By integrating both assessments, the study seeks to identify a PEEP level that optimizes pulmonary function while minimizing adverse effects on cerebral physiology. The overarching goal is to develop an individualized, brain-protective ventilation strategy for patients with ARDS and ABI.

Conditions

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Acute Respiratory Distress Syndrome (ARDS) Acute Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stepwise PEEP Elevation Protocol Arm

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.

Group Type EXPERIMENTAL

Stepwise Positive End-Expiratory Pressure (PEEP) Increase Protocol

Intervention Type 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.

Interventions

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Stepwise Positive End-Expiratory Pressure (PEEP) Increase Protocol

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theodoros Schizodimos

OTHER

Sponsor Role lead

Responsible Party

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Theodoros Schizodimos

Theodoros Schizodimos

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Theodoros Schizodimos, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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George Papanikolaou General Hospital

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Theodoros Schizodimos, MD

Role: CONTACT

Phone: +306973439717

Email: [email protected]

Georgia Pitsiou, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Theodoros Schizodimos

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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10957

Identifier Type: -

Identifier Source: org_study_id