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Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO

NCT03764319 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-04-17

No results posted yet for this study

Summary

The acute respiratory distress syndrome (ARDS) is the most severe form of respiratory failure, presented in 10% of all intensive care patients and carrying a high mortality rate. Extracorporeal membrane oxygenation (ECMO) is a rescue treatment for patients with severe ARDS. Mechanical ventilator settings in patients with severe ARDS during ECMO therapy are not clearly defined at the moment.

Conditions

  • ARDS
  • Acute Lung Injury
  • Extracorporeal Membrane Oxygenation
  • Respiratory Distress Syndrome
  • Respiratory Tract Diseases
  • Lung Diseases
  • Lung Injury, Acute

Interventions

OTHER

Ultra-protective ventilator settings

4-5 Breaths per minute; 14-16 cmH2O Positive endexpiratory pressure (PEEP) (adjust PEEP to 23 \< Plateau pressure \< 25 cmH2O); 23-25 cmH2O Plateau pressure (adjust to not exceed Tidal volume \> 4 mL/kg Predicted body weight (PBW)); \< 4mL/kg PBW Tidal volume; 1:5 Inspiration:Expiration (I:E)

OTHER

Standard ventilator settings

12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Roman Ullrich, Ao.Univ.Prof. · Department of Anesthesia and Intensive Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2021-08-01
Completion
2021-08-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764319 on ClinicalTrials.gov