Health TrialsbyHealthPanel

Regional Assessment of the Risk of Lung Injury in Ventilated Patients

ConditionARDS, Human
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHospital El Cruce

About this trial

Specific characteristics of the lung, such as its functional capacity, heterogeneity, and recruitment potential, can influence the development of ventilator-induced lung injury even under safe ventilation conditions. Objective: To evaluate the risk of ventilator-induced lung injury at the regional level in patients with acute respiratory distress syndrome ventilated with similar tidal volumes and inspiratory pressures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

History of emphysema, asthma, pneumothorax, or active bronchopulmonary fistula.

Severe instability at the time of the study defined by at least one of the following indicators: SaO2 ≤ 90%, shock requiring > 0.5 γ/kg/min of noradrenaline, complex arrhythmia, myocardial ischemia, intracranial hypertension refractory despite first-line measures.

Esophageal pathology contraindicating esophageal balloon placement (esophageal varices, stenosis, trauma or esophageal surgery, tumor) and/or hematemesis.

Severe coagulopathy (platelet count <20,000/mm3 or INR >4.

Trial population

Patients with acute respiratory distress syndrome requiring mechanical ventilatory assistanc

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Controlled mechanical ventilation

    Other intervention

    Patients were ventilated under similar tidal volume, respiratory rate, and plateau pressure. PEEP was the adjustment variable to reach a similar plateau pressure

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: ventral1 intervention
Group B: Dorsal1 intervention

Trial outcomes

Primary outcomes

1

comparison of regional lung volume

comparison of regional lung volume in ml

Time frame
1 hour

Secondary outcomes

1

comparison of regional volume of hyperinflated lung

comparison of regional volume of hyperinflated lung in ml

Time frame
1 hour
2

comparison of regional lung deformation

comparison of regional lung deformation in percentage

Time frame
1 hour
3

comparison of the amount of unstable lung

comparison of the amount of unstable lung in percentage

Time frame
1 hour

Other outcomes

Sponsors and contacts

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

Hospital El Cruce

Lead sponsor

Source ClinicalTrials.gov
Apply now