Optimisation of mechanical ventilation in patients with ARDS caused by COVID-19 based on individual PEEP determination by PEEP titration using electrical impedance tomography - a controlled clinical pilot trial

Not Applicable

• Conditions: J80; U07.1; Adult respiratory distress syndrome; COVID-19, virus identified

• Registration Number: DRKS00030886
• Lead Sponsor: niversitätsklinikum Augsburg

Brief Summary

Because of the cancellation of the study, no sufficient results could be achieved.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-19
• Study Completion: 2023-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. ARDS as defined by Berlin meet the following criteria (all):
a.Sudden onset
b.Bilateral infiltrates in chest x-ray or CT chest
c.PaO2/FiO2 < 300
d.No clinical evidence of cardiac cause of respiratory failure
2. need for intubation and invasive ventilation
3. written informed consent

Exclusion Criteria

1. age < 18 years
2. known pulmonary fibrosis/restrictive ventilation disorder
3. severe emphysema
4. pregnancy and breastfeeding
5. severe cardiac disease (New York Heart Association classification III or IV, acute ischaemic event, persistent ventricular arrhythmia)
6. pre-existing neuromuscular disease
7. implanted pacemaker or ICD
8. participation in other interventional studies within the last three months
9. severity of illness that makes death within the next 24 h highly probable in the investigator's opinion
10. DNR/DNI order

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2 one hour after setting PEEP in each group

Secondary Outcome Measures

Name	Time	Method
Adjusted PEEP<br>Barotrauma<br>Haemodynamic instability <br>Description of ventilation distribution in early ARDS<br>Effects of PEEP determination on ventilation distribution<br>Correlation of physiological parameters of lung function with the results of quantitative CT analysis<br>Histological degree of lung damage (if autopsy is performed)