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Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031275
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Bernhard Holzgraefe, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE January 10, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date January 25, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure
Official Title  ICMJE Not Provided
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (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).
Primary Purpose: Other
Condition  ICMJE
  • Long Term Adverse Effects
  • Pneumonia
  • Acute Respiratory Distress Syndrome
  • Sepsis
  • Critical Illness
  • Cognitive Impairment
  • Extracorporeal Circulation; Complications
Intervention  ICMJE
  • Radiation: High-resolution computed tomography
    HRCT of the thorax
  • Radiation: Magnetic resonance imaging
    MRI of the brain
  • Behavioral: Cognitive testing
    Neuropsychological testing
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2017)
31
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03031275
Other Study ID Numbers  ICMJE 2013/2258-31/1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bernhard Holzgraefe, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Karolinska University Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP