Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of Participants With Abnormal Lungs radiographic findings assessed by high-resolution CT scan
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients treated with ECMO at the ECMO Center Karolinska 1995 - July 2009
排除标准
- •Diseased patients
- •Patients living abroad (including non-Swedish citizens)
- •Patients treated for non-respiratory conditions
- •Patients with a known pre-ECMO mental handicap
结局指标
主要结局
Number of Participants With Abnormal Lungs radiographic findings assessed by high-resolution CT scan
时间窗: 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
时间窗: 5-17 years after treatment
Number of Participants With Abnormal Pulmonary function
时间窗: 5-17 years after treatment
Static and dynamic spirometry. Measured results as % of the expected normal values were presented.
Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests
时间窗: 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
时间窗: 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 signs of a reduced health related quality-of-life, assessed by the Short Form-36
时间窗: 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
时间窗: 5-17 years after treatment
Number of participants with signs of a reduced exercise tolerance
时间窗: 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
时间窗: 5-17 years after treatment
次要结局
未报告次要终点
研究者
Bernhard Holzgraefe
MD, PhD
Karolinska University Hospital