Treatment of severe acute respiratory failure patients requiring Extracorporeal Membrane Oxygenation (ECMO)

Not Applicable

Completed

• Conditions: severe acute respiratory failure patients requiring treatment by the Extracorporeal Membrane Oxygenation (ECMO)

• Registration Number: JPRN-jRCT1092220327
• Lead Sponsor: Getinge Group Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-01
• Study Completion: 2019-09-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Patients who are able to provide written consent to participate in the study
2.Ages between 20 and 75 years old; no gender restriction
3.Longer than 6 hours of ECMO therapy is expected
4.Meets at least one of the 3 criteria below:
-FiO2 >0.8, PFR<100mmHg, PEEP>=10cmH2O
-Uncompensated hypercapnia (PaCO2 >80mmHg) in spite of PIP>=30cmH2O
-Serious air leak syndrome

Exclusion Criteria

1.Cause of the severe respiratory failure is determined to be irreversible respiratory disease
2.Remaining on high ventilator settings (FiO2 >0.9, PIP >30cmH2O) for more than 7 days
3.Serious immunodeficiency (Neu<400mm3)
4.Pre-existing conditions (central nervous system disorder, end-stage malignancy, systemic bleeding risk due to ECLS anticoagulation) which may have significant impact on QOL
5.Severe aortic valve insufficiency in the case of VA circulation
6.Patients with known hypersensitivity to heparin
7.Patients currently suffering from, or with a history of type II antibody-related, heparin-induced thrombocytopenia (HIT)
8.Pregnant or possibility of pregnancy
9.Participating in another clinical trial or Postmarketing clinical study
10.Those patients determined by the investigator to be inappropriate to participate in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of MJ-CP042-01 used

Secondary Outcome Measures

Name	Time	Method
-Change in patient PFR<br>-Changes in device PFR and pressure gradient pre/post oxygenator<br>-Rate of device (procedure) change due to subject condition<br>-Percentage of patients on ECMO after 6 hours<br>-Percentage of patients on ECMO after 14 days<br>-Other parameters at 14 and 30 days:<br>-Overall survival rate and survival rate of patients who were weaned<br>-Exchange of device due to device failure (frequency, days used)<br>-Average time device is used when there is no device exchange (except for death)<br>-Average time device is used in all patients without device exchange<br>-Over all average of hours device is used