Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure
Primary Purpose
Long Term Adverse Effects, Pneumonia, Acute Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
High-resolution computed tomography
Magnetic resonance imaging
Cognitive testing
Sponsored by
About this trial
This is an interventional other trial for Long Term Adverse Effects focused on measuring extracorporeal circulation, critical care outcomes
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
Sites / Locations
- ECMO Center Karolinska
Outcomes
Primary Outcome Measures
Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests
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
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
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
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
Number of participants with signs of a reduced health related quality-of-life, assessed by the Short Form-36
Number of participants with signs of a reduced Health related quality-of-life, assessed by the S:t George´s Respiratory Questionnaire
Number of participants with signs of a reduced exercise tolerance
6-minute walking test
Number of participants with signs of anxiety and depression assessed by the Hospital and Anxiety Depression Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03031275
First Posted
January 10, 2017
Last Updated
January 22, 2017
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03031275
Brief Title
Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long Term Adverse Effects, Pneumonia, Acute Respiratory Distress Syndrome, Sepsis, Critical Illness, Cognitive Impairment, Extracorporeal Circulation; Complications
Keywords
extracorporeal circulation, critical care outcomes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
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).
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
High-resolution computed tomography
Intervention Description
HRCT of the thorax
Intervention Type
Radiation
Intervention Name(s)
Magnetic resonance imaging
Intervention Description
MRI of the brain
Intervention Type
Behavioral
Intervention Name(s)
Cognitive testing
Intervention Description
Neuropsychological testing
Primary Outcome Measure Information:
Title
Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests
Description
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.
Time Frame
5-17 years after treatment
Title
Number of participants with abnormal brain imaging assessed by magnetic resonance imaging
Description
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.
Time Frame
5-17 years after treatment
Title
Number of Participants With Abnormal Pulmonary function
Description
Static and dynamic spirometry. Measured results as % of the expected normal values were presented.
Time Frame
5-17 years after treatment
Title
Number of Participants With Abnormal Lungs radiographic findings assessed by high-resolution CT scan
Description
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.
Time Frame
5-17 years after treatment
Title
Number of participants with signs of post-traumatic stress assessed by the Trauma Screening Questionnaire
Time Frame
5-17 years after treatment
Title
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
Title
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
Title
Number of participants with signs of a reduced exercise tolerance
Description
6-minute walking test
Time Frame
5-17 years after treatment
Title
Number of participants with signs of anxiety and depression assessed by the Hospital and Anxiety Depression Scale
Time Frame
5-17 years after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
ECMO Center Karolinska
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
12. IPD Sharing Statement
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Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure
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