Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure
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|ClinicalTrials.gov Identifier: NCT03031275|
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Long Term Adverse Effects Pneumonia Acute Respiratory Distress Syndrome Sepsis Critical Illness Cognitive Impairment Extracorporeal Circulation; Complications||Radiation: High-resolution computed tomography Radiation: Magnetic resonance imaging Behavioral: Cognitive testing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking Description:||All investigators (radiologist, neuropsychologist, physiotherapist) were masked from all patient details other than the fact that they were treated with ECMO (ie did not know when the patient was treated, for what condition, if any side effects were seen and so on).|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2016|
- Radiation: High-resolution computed tomography
HRCT of the thorax
- Radiation: Magnetic resonance imaging
MRI of the brain
- Behavioral: Cognitive testing
- Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests [ Time Frame: 5-17 years after treatment ]Wechsler Adult Intelligence Scale, 4th ed, Rey Auditory Verbal Learning Test (learning trials 1 to 5 and delayed recall), immediate recall from the Rey Complex Figure and Logical Memory I and II from Wechsler Memory Scale, 3rd ed.
- Number of participants with abnormal brain imaging assessed by magnetic resonance imaging [ Time Frame: 5-17 years after treatment ]Sagittal and axial T1- and T2-weighted images, and coronal T2-weighted and T2-weighted fluid attenuated inversion recovery (FLAIR) images. Slice thickness 4 mm. Presence of hypoxic or anoxic damage, infarctions, hemorrhages, and contusion damage were described.
- Number of Participants With Abnormal Pulmonary function [ Time Frame: 5-17 years after treatment ]Static and dynamic spirometry. Measured results as % of the expected normal values were presented.
- Number of Participants With Abnormal Lungs radiographic findings assessed by high-resolution CT scan [ Time Frame: 5-17 years after treatment ]Non-contrast spiral scan. A series for grading of pulmonary changes was reconstructed, using a high spatial resolution reconstruction algorithm with 1 mm-width, overlapping slices. Four patterns were mapped: reticular, ground-glass opacification, consolidation and decreased attenuation.
- Number of participants with signs of post-traumatic stress assessed by the Trauma Screening Questionnaire [ Time Frame: 5-17 years after treatment ]
- Number of participants with signs of a reduced health related quality-of-life, assessed by the Short Form-36 [ Time Frame: 5-17 years after treatment ]
- Number of participants with signs of a reduced Health related quality-of-life, assessed by the S:t George´s Respiratory Questionnaire [ Time Frame: 5-17 years after treatment ]
- Number of participants with signs of a reduced exercise tolerance [ Time Frame: 5-17 years after treatment ]6-minute walking test
- Number of participants with signs of anxiety and depression assessed by the Hospital and Anxiety Depression Scale [ Time Frame: 5-17 years after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031275
|ECMO Center Karolinska|
|Stockholm, Sweden, 17176|