NCT03764319

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

April 17, 2025

Status Verified

September 1, 2021

Enrollment Period

2.7 years

First QC Date

November 29, 2018

Last Update Submit

April 13, 2025

Conditions

ARDSAcute Lung InjuryExtracorporeal Membrane OxygenationRespiratory Distress SyndromeRespiratory Tract DiseasesLung DiseasesLung Injury, Acute

Keywords

ARDS, ECMO, Ventilation

Outcome Measures

Primary Outcomes (2)

  • Ventilator free days

    Ventilator free days

    Immediately after initiation of ECMO up to 28 days

  • Time from randomization to fulfillment of extubation criteria

    Time from randomization (initiation of ECMO) to fulfillment of the extubation criteria: * ARDS resolved * Temperature ≥ 36°C and ≤ 39°C * Low FiO2 (\< 0.5) * PEEP (\< 8 cmH2O) requirement * Able to initiate spontaneous breaths * Tidalvolume \> 5 mL/kg or \> 325 mL * Minute ventilation 5-6 L/min * PaO2/FiO2 \> 200 mmHg * pH ≥ 7.25 * Ability to cough after deflating tube cuff * Respiratory rate 8-30/min * Hemodynamic stability

    Immediately after initiation of ECMO up to 28 days

Secondary Outcomes (8)

  • Total time of mechanical ventilation

    Start of mechanical ventilation up to 28 days

  • 28 day mortality

    Immediately after initiation of ECMO up to 28 days

  • One year mortality

    Immediately after initiation of ECMO up to one year

  • Incidence of reintubation

    Immediately after initiation of ECMO up to 28 days

  • Length of ICU stay

    Immediately after initiation of ECMO

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Ultra-protective ventilator settings in patients with ARDS and ECMO.

Other: Ultra-protective ventilator settings

Control group

ACTIVE COMPARATOR

Standard ventilator settings in patients with ARDS and ECMO.

Other: Standard ventilator settings

Interventions

Ultra-protective ventilator settingsOTHER

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)

Intervention group
Standard ventilator settingsOTHER

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

Control group

Eligibility Criteria

Age18 Years - 99 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe ARDS - Partial pressure of oxygen/Fraction of inspired oxygen (PaO2/FiO2) \< 200 mmHg
  • ECMO \< 24 hours in situ
  • Gender-matched
  • Age-matched

You may not qualify if:

  • BMI \> 40
  • Expected weaning of ECMO \< 3 days (postoperative ECMO)
  • Combustion
  • Restrictive chest wall impairment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine

Vienna, Austria, 1090, Austria

Location

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress SyndromeRespiratory Tract DiseasesLung DiseasesRespiratory Aspiration

Condition Hierarchy (Ancestors)

Lung InjuryRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roman Ullrich, Ao.Univ.Prof.

    Department of Anesthesia and Intensive Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison of 2 groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

November 29, 2018

First Posted

December 5, 2018

Study Start

November 6, 2018

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

April 17, 2025

Record last verified: 2021-09

Locations

AU(1)