Clinical trial NCT03031275: Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long Term Adverse Effects
Pneumonia
Acute Respiratory Distress Syndrome
Sepsis
Critical Illness
Cognitive Impairment
Extracorporeal Circulation; Complications
Keywords: extracorporeal circulation
critical care outcomes
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center Karolinska.

Patients: adult survivors treated with ECMO for severe refractory respiratory failure at least 5 years earlier.

Investigations: brain and pulmonary radiographic morphology, cognitive testing, pulmonary function testing, exercise tolerance, quality of life and mood disorder screening.

Detailed description: All adult patients treated at the ECMO Center Karolinska between 1995 and July 2009 were screened for eligibility in January 2014. Patients living abroad (including non-Swedish citizens), patients treated for non-respiratory conditions, diseased patients and patients with a known pre-ECMO mental handicap were excluded.

Eligible patients were contacted, and patients who agreed to participate gave their written informed consent. All studied patients underwent the same study protocol during a day at the hospital, including a clinical interview, MRI scan of the brain, HRCT scan of the thorax, pulmonary function testing, neuropsychological examination, walking test, self assessment questionnaires for quality of life, anxiety, depression and post-traumatic stress.

Patient charts were reviewed for relevant clinical information, including age, gender, ECMO mode (venovenous or venoarterial), time in hospital, on ECMO, non-ECMO ICU and on mechanical ventilation; preexisting diseases, blood gas values and ventilator settings before initiation of ECMO treatment. Hand written clinical data from the patients´ charts from every hour with ECMO treatment was reviewed for ventilator settings, lung volumes, mean arterial pressure, hemoglobin, lactate and oxygenation parameters during an observation period, which was defined as the first 10 days on ECMO (or the entire treatment period if shorter than 10 days). This information was added to a digital database for the purpose of this study.

At the time of ECMO treatment, arterial hemoglobin oxygen saturation was measured by peripheral pulse oximetry from the right ear, finger or nose. Venous preoxygenator lactate and venous saturation values were used as indicators of sufficient (lactate \< 2 mmol l-1 , SvO2 ≥ 70%) or insufficient tissue perfusion.

Eligibility criteria: Inclusion Criteria:

* Adult patients treated with ECMO at the ECMO Center Karolinska 1995 - July 2009

Exclusion Criteria:

* Diseased patients
* Patients living abroad (including non-Swedish citizens)
* Patients treated for non-respiratory conditions
* Patients with a known pre-ECMO mental handicap

Primary outcomes:
measure: Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests
timeFrame: 5-17 years after treatment
measure: Number of participants with abnormal brain imaging assessed by magnetic resonance imaging
timeFrame: 5-17 years after treatment
measure: Number of Participants With Abnormal Pulmonary function
timeFrame: 5-17 years after treatment
measure: Number of Participants With Abnormal Lungs radiographic findings assessed by high-resolution CT scan
timeFrame: 5-17 years after treatment
measure: Number of participants with signs of post-traumatic stress assessed by the Trauma Screening Questionnaire
timeFrame: 5-17 years after treatment
measure: Number of participants with signs of a reduced health related quality-of-life, assessed by the Short Form-36
timeFrame: 5-17 years after treatment
measure: Number of participants with signs of a reduced Health related quality-of-life, assessed by the S:t George´s Respiratory Questionnaire
timeFrame: 5-17 years after treatment
measure: Number of participants with signs of a reduced exercise tolerance
timeFrame: 5-17 years after treatment
measure: Number of participants with signs of anxiety and depression assessed by the Hospital and Anxiety Depression Scale
timeFrame: 5-17 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: ECMO Center Karolinska
Study officials:
References: