Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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
Study Start Date : January 2014
Actual Primary Completion Date : December 2016



Intervention Details:
  • Radiation: High-resolution computed tomography
    HRCT of the thorax
  • Radiation: Magnetic resonance imaging
    MRI of the brain
  • Behavioral: Cognitive testing
    Neuropsychological testing


Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Number of participants with signs of post-traumatic stress assessed by the Trauma Screening Questionnaire [ Time Frame: 5-17 years after treatment ]
  6. 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 ]
  7. 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 ]
  8. Number of participants with signs of a reduced exercise tolerance [ Time Frame: 5-17 years after treatment ]
    6-minute walking test

  9. Number of participants with signs of anxiety and depression assessed by the Hospital and Anxiety Depression Scale [ Time Frame: 5-17 years after treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Sweden
ECMO Center Karolinska
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska University Hospital
Layout table for additonal information
Responsible Party: Bernhard Holzgraefe, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03031275    
Other Study ID Numbers: 2013/2258-31/1
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Keywords provided by Bernhard Holzgraefe, Karolinska University Hospital:
extracorporeal circulation
critical care outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Critical Illness
Long Term Adverse Effects
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Disease Attributes
Pathologic Processes
Lung Injury