Ultra-protective Pulmonary Ventilation Supported by Low Flow ECCO2R for Severe ARDS

NCT02252094 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-09-14

No results posted yet for this study

Summary

This study evaluates the use of ultra-protective ventilation, where very low ventilation volumes are used, in patients with severe acute respiratory distress syndrome (ARDS) meeting criteria to nurse in the prone position. Half the patients will receive ultra-protective ventilation support by extracorporeal carbon dioxide removal, while the other half will receive conventional lung protective ventilation.

Conditions

  • Respiratory Distress Syndrome, Adult

Interventions

DEVICE

Prismalung

Prism lung (Baxter Healthcare/Gambro Lund, Sweden) is an extracorporeal carbon dioxide removal device. It removes blood through a double lumen catheter and pumps it through a hollow fiber gas exchange cartridge which is impervious to fluid. Carbon dioxide diffuses out, down a concentration gradient which is maintained by sweep gas flowing through the centre of the hollow fibres. The decarboxylated blood is returned to the patient through the double lumen catheter.

OTHER

Ultra-protective ventilation

Ventilation with \</= 3ml/kg predicted body weight

OTHER

Conventional Lung Protective Ventilation

Ventilation with 6ml/kg predicted body weight

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY
  • National University Health System, Singapore

    lead OTHER

Principal Investigators

  • Matthew E Cove, MBChB · National University Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Singapore

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 NCT02252094 on ClinicalTrials.gov