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

ConditionsAcute Respiratory Distress Syndrome (ARDS)Acute Brain Injury

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorTheodoros Schizodimos

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe chronic brain diseases

Brain tumor or central nervous system (CNS) infection

Severe chronic pulmonary or cardiovascular disease

Severe coagulopathy

Trial design

Design model

Single group

Treatments tested in this trial

Stepwise Positive End-Expiratory Pressure (PEEP) Increase Protocol
Procedure/Surgery
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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Stepwise PEEP Elevation Protocol ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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

Secondary outcomes

Correlation Between PEEP Difference and Clinical Outcomes

Correlation between the difference in PEEP levels (cmH₂O) and the following clinical outcomes: duration of mechanical ventilation, ICU length of stay, and ICU/hospital mortality. Unit of Measure: PEEP difference: cmH₂O, Duration of mechanical ventilation: days, ICU length of stay: days, ICU mortality: %, Hospital mortality: %

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Theodoros Schizodimos

Lead sponsor

George Papanicolaou Hospital

Sponsor institution

Source ClinicalTrials.gov

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