Estimation of Outcome and Quality of Life in ECMO Patients
ConditionExtracorporeal Membrane Oxygenation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf
About this trial
The availability as well as the use of extracorporeal membrane oxygenation (ECMO) systems for severe acute respiratory or cardiocirculatory failure is steadily increasing. The decision to initiate ECMO therapy is predominantly made in emergency situations, for which the focus is on acute survival. The decisions if a patient will profit from ECMO therapy are mainly made from clinical experience and educated guess by the attending team. However, it is unknown how useful these clinical predictions are. Therefore, this observational study will compare estimated and real outcome of ECMO patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥ 18 years
start of ECMO therapy ≤24h
written informed consent from patient or health-care proxy
Disqualifiers
age < 18 years
Language barrier (communication in German/local language or English not possible).
no ECMO therapy or ECMO therapy longer than 24h
no written consent
Trial population
All patients aged above 18 years in the ICU with a vv- or va-ECMO for less than 24 hours will be included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
estimation of patient outcome by health care providers
Other interventionOn day 1 after study inclusion as well as day 4-7, the responsible health-care providers (at least one nurse, one resident and one consultant with the board certification intensive care medicine) will estimate the patient's expected functional outcome at 6 and 12 months after the start of ECMO therapy. Health-care providers responsible for the patient at that time will be surveyed (multiple questionnaires to detect specific differences within one person are not planned). For the purpose of functional outcome estimation, the modified Rankin scale (mRS) is used.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: ECMO patients1 intervention
Trial outcomes
Primary outcomes
1
Agreement between estimated outcome by healthcare providers and actual patient outcome on Modified Rankin scale mRS
The primary endpoint of this study will be the agreement between functional performance of patients estimated by different healthcare provider groups and actual functional performance of patients after start of ECMO therapy measured by the 7-item mRS.
Time frame
6 months and 12 months after ECMO therapySecondary outcomes
1
Disability-free survival (WHODAS 2.0)
As secondary endpoints we will assess disability free survival at 6 and 12 months after ECMO therapy using the WHODAS 2.0 questionnaire with a disability threshold of ≥16 % for mild disability and ≥35% for severe disability as described previously by Shulman et al.
Time frame
6 months and 12 months after ECMO therapy2
Days alive and out of hospital (DAOH)
we will assess Days alive and out of hospital at 6 and 12 months after initiation of ECMO therapy, as additional life impact parameter which was previously investigated in other cohorts
Time frame
6 months and 12 months after ECMO therapy3
Moral distress
we will assess the level of moral distress of ICU health care providers (consultants, residents and nursing personnel) taking care of the individual patient using the Moral Distress Thermometer.
Time frame
Day 1 and day 4-7 of ECMO therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov